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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04071847
Registration number
NCT04071847
Ethics application status
Date submitted
26/08/2019
Date registered
28/08/2019
Date last updated
28/05/2024
Titles & IDs
Public title
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
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Scientific title
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
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Secondary ID [1]
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ABT-CIP-10300
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Universal Trial Number (UTN)
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Trial acronym
ADROIT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Movement Disorders
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Parkinson Disease
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Essential Tremor
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Tremor
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Dystonia
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Primary Dystonia
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Secondary Dystonia
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Condition category
Condition code
Neurological
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Parkinson's disease
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Neurological
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Other neurological disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Deep Brain Stimulation (DBS)
Deep brain stimulation - Subjects implanted with an Abbott DBS system
Treatment: Devices: Deep Brain Stimulation (DBS)
Deep brain stimulation therapy involves the delivery of electrical signals to targeted structures in the brain to modulate neural circuit activity, and has been used successfully for the treatment of various types of movement disorders, including Parkinson's disease (PD), disabling or essential tremor, and dystonia
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline to 6 months in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
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Assessment method [1]
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The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms.
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Timepoint [1]
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Baseline to 6 months
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Primary outcome [2]
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Change from baseline to1 year in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
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Assessment method [2]
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The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms.
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Timepoint [2]
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Baseline to1 year
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Primary outcome [3]
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Change from baseline to 2 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
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Assessment method [3]
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The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms.
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Timepoint [3]
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Baseline to 2 years
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Primary outcome [4]
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Change from baseline to 3 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
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Assessment method [4]
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0
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms.
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Timepoint [4]
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Baseline to 3 years
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Primary outcome [5]
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Change from baseline to 4 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
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Assessment method [5]
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0
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms.
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Timepoint [5]
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Baseline to 4 years
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Primary outcome [6]
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Change from baseline to 5 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III.
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Assessment method [6]
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0
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assess the severity of Parkinson's disease. This questionnaire is composed of four sections: Part I: non-motor experiences of daily living consisting of 13 questions (Part Ia is assessed by the investigator while part Ib is assessed by the subject, with or without the help of the caregiver); Part II: motor experiences of daily living consisting of 13 questions, designed to be self-administered; Part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores; Part IV: motor complications: consisting of 6 questions. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score for each part is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms.
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Timepoint [6]
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Baseline to 5 years
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Primary outcome [7]
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Change from baseline to 6 months in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
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Assessment method [7]
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The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.
The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.
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Timepoint [7]
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Baseline to 6 months
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Primary outcome [8]
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Change from baseline to 1 year in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
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Assessment method [8]
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0
The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.
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Timepoint [8]
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Baseline to 1 year
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Primary outcome [9]
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Change from baseline to 2 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
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Assessment method [9]
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0
The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.
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Timepoint [9]
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Baseline to 2 years
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Primary outcome [10]
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Change from baseline to 3 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
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Assessment method [10]
0
0
The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.
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Timepoint [10]
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Baseline to 3 years
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Primary outcome [11]
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Change from baseline to 4 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
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Assessment method [11]
0
0
The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability. The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.
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Timepoint [11]
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Baseline to 4 years
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Primary outcome [12]
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Change from baseline to 5 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
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Assessment method [12]
0
0
The Fahn-Tolosa-Marin Tremor Rating Scale (FTMTRS) assesses tremor severity and and consists of three parts. Part A (with a maximum score of 80) rates tremor at rest, during posture, and intentional movements for nine parts of the body, including the head, trunk and limbs; Part B (with a maximum score of 36) rates action tremor of the upper limbs, particularly while writing and pouring liquids; part C the patient rates the impact of tremor on his or her functional disability (speaking, feeding, drinking, hygiene, dressing, writing, and working) with a maximum score of 28. The total score obtained by adding the three parts of the FTM-TRS is 144, with a higher score indicating higher disease severity/disability.The FTM-TRS also includes one separate item dealing with global assessment of tremor-related disability, rated by both patient and examiner on a 5-point scale.
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Timepoint [12]
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Baseline to 5 years
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Primary outcome [13]
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Change from baseline to 6 months in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
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Assessment method [13]
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0
The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability.
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Timepoint [13]
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Baseline to 6 months
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Primary outcome [14]
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Change from baseline to 1 year in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
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Assessment method [14]
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0
The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability.
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Timepoint [14]
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Baseline to 1 year
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Primary outcome [15]
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Change from baseline to 2 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
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Assessment method [15]
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0
The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability.
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Timepoint [15]
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Baseline to 2 years
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Primary outcome [16]
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Change from baseline to 3 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
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Assessment method [16]
0
0
The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability.
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Timepoint [16]
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Baseline to 3 years
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Primary outcome [17]
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0
Change from baseline to 4 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
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Assessment method [17]
0
0
The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability.
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Timepoint [17]
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0
Baseline to 4 years
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Primary outcome [18]
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0
Change from baseline to 5 years in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
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Assessment method [18]
0
0
The BFMDRS consists consists of a movement subscale and a disability subscale. The movement scale measures dystonia in nine body regions (including the eyes, mouth, speech and swallowing, neck, trunk, arms, and legs). Each domain is scored on degree of provoking factor (0=no dystonia at rest or with action to 4=dystonia present at rest) and severity factor (0=no dystonia to 4=extreme/severe dystonia). Scores are weighted yielding a total score ranging from 0 to 120. The disability scale is a functional marker consisting of parental- or self-reported daily activities (involving speech, handwriting, feeding, eating, swallowing, hygiene, dressing, and walking), with scores ranging from 0 (completely independent) to 30 (completely dependent). A higher score indicates higher disease severity/disability.
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Timepoint [18]
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0
Baseline to 5 years
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Primary outcome [19]
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0
Change from baseline to 6 months in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
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Assessment method [19]
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0
The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain.
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Timepoint [19]
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0
Baseline to 6 months
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Primary outcome [20]
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0
Change from baseline to 1 year in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
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Assessment method [20]
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0
The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain.
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Timepoint [20]
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0
Baseline to 1 year
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Primary outcome [21]
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0
Change from baseline to 2 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
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Assessment method [21]
0
0
The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain.
Query!
Timepoint [21]
0
0
Baseline to 2 years
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Primary outcome [22]
0
0
Change from baseline to 3 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
Query!
Assessment method [22]
0
0
The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain.
Query!
Timepoint [22]
0
0
Baseline to 3 years
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Primary outcome [23]
0
0
Change from baseline to 4 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
Query!
Assessment method [23]
0
0
The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain.
Query!
Timepoint [23]
0
0
Baseline to 4 years
Query!
Primary outcome [24]
0
0
Change from baseline to 5 years in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
Query!
Assessment method [24]
0
0
The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) severity subscale rates the severity of cervical dystonia. This scale consists of three subscales measuring symptom severity, disability, and pain. The severity scale is rated by the clinician and is composed of 11 items with a maximum score of 35. The disability and pain scales are patient-rated. The disability scale is composed of 6 items with a maximum score of 30. The pain scale is composed of 3 items with a maximum score of 20. The total TWSTRS score ranges from 0 to 85 points. Higher scores indicate higher severity/disability/pain.
Query!
Timepoint [24]
0
0
Baseline to 5 years
Query!
Primary outcome [25]
0
0
Incidence of device- and procedure-related serious adverse events at 6 months
Query!
Assessment method [25]
0
0
Serious Adverse Events related to the device and procedure will be assessed.
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).
a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.
v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect.
Query!
Timepoint [25]
0
0
At 6 months
Query!
Primary outcome [26]
0
0
Incidence of device- and procedure-related serious adverse events at 1 year
Query!
Assessment method [26]
0
0
Serious Adverse Events related to the device and procedure will be assessed.
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).
a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.
v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect.
Query!
Timepoint [26]
0
0
At 1 year
Query!
Primary outcome [27]
0
0
Incidence of device- and procedure-related serious adverse events at 2 years
Query!
Assessment method [27]
0
0
Serious Adverse Events related to the device and procedure will be assessed.
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).
a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.
v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect.
Query!
Timepoint [27]
0
0
At 2 years
Query!
Primary outcome [28]
0
0
Incidence of device- and procedure-related serious adverse events at 3 years
Query!
Assessment method [28]
0
0
Serious Adverse Events related to the device and procedure will be assessed.
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).
a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.
v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect.
Query!
Timepoint [28]
0
0
At 3 years
Query!
Primary outcome [29]
0
0
Incidence of device- and procedure-related serious adverse events at 4 years
Query!
Assessment method [29]
0
0
Serious Adverse Events related to the device and procedure will be assessed.
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).
a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.
v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect.
Query!
Timepoint [29]
0
0
At 4 years
Query!
Primary outcome [30]
0
0
Incidence of device- and procedure-related serious adverse events at 5 years
Query!
Assessment method [30]
0
0
Serious Adverse Events related to the device and procedure will be assessed.
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).
a) Led to a death, b) Led to a serious deterioration in health of the subject, that either resulted in i) a life-threatening illness or injury, or ii) a permanent impairment of a body structure or a body function, or iii) in-patient hospitalization or prolongation of existing hospitalization, or iv) medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body function.
v) chronic disease c) Led to fetal distress, fetal death or a congenital abnormality or birth defect.
Query!
Timepoint [30]
0
0
At 5 years
Query!
Eligibility
Key inclusion criteria
1. Subject is scheduled for a new implant or IPG device replacement surgery with a
market-released Abbott DBS system within 180 days.
2. Subject, or a legally acceptable representative, must provide written informed consent
prior to any study-related procedure.
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Subject is currently enrolled or plans to enroll in an investigational study that may
confound the results of this study.
2. Subject has anatomic or comorbid conditions, or other medical, social, or
psychological conditions that, in the investigator's opinion, could limit the
subject's ability to participate in the study or to comply with follow-up
requirements, or impact the scientific soundness of the study results.
3. Study center is located in the United States, and indication for DBS implant is not
Parkinson's disease or disabling tremor.
4. Study center is located in the United States, and the intended lead implant location
is not at, or in close proximity to, the STN, GPi, or VIM thalamus.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
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Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
26/11/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/09/2030
Query!
Actual
Query!
Sample size
Target
1000
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Query!
Recruitment hospital [1]
0
0
Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [2]
0
0
Royal Melbourne Hospital - City Campus - Parkville
Query!
Recruitment postcode(s) [1]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [2]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New Hampshire
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Ohio
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Pennsylvania
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Texas
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Utah
Query!
Country [17]
0
0
Finland
Query!
State/province [17]
0
0
Uusimaa
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Auvergne
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
ILE
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Provence-Alpes-Azur
Query!
Country [21]
0
0
Germany
Query!
State/province [21]
0
0
Baden-Wurttemberg
Query!
Country [22]
0
0
Germany
Query!
State/province [22]
0
0
North Rhine-Westphalia
Query!
Country [23]
0
0
Germany
Query!
State/province [23]
0
0
Rhineland-Palatinate
Query!
Country [24]
0
0
Germany
Query!
State/province [24]
0
0
Hamburg
Query!
Country [25]
0
0
Italy
Query!
State/province [25]
0
0
Emilia-Romagna
Query!
Country [26]
0
0
Italy
Query!
State/province [26]
0
0
Latium
Query!
Country [27]
0
0
Italy
Query!
State/province [27]
0
0
Lombardy
Query!
Country [28]
0
0
Spain
Query!
State/province [28]
0
0
Andalusia
Query!
Country [29]
0
0
Spain
Query!
State/province [29]
0
0
Catalonia
Query!
Country [30]
0
0
Spain
Query!
State/province [30]
0
0
Madrid
Query!
Country [31]
0
0
Taiwan
Query!
State/province [31]
0
0
Ntaiwan
Query!
Country [32]
0
0
Taiwan
Query!
State/province [32]
0
0
Hualien City
Query!
Country [33]
0
0
United Kingdom
Query!
State/province [33]
0
0
North West England
Query!
Country [34]
0
0
United Kingdom
Query!
State/province [34]
0
0
South West England
Query!
Country [35]
0
0
United Kingdom
Query!
State/province [35]
0
0
Wdbtshr
Query!
Country [36]
0
0
United Kingdom
Query!
State/province [36]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Abbott Medical Devices
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The purpose of this international study is to evaluate long-term safety and effectiveness of
Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's
disease, essential tremor or other disabling tremor and dystonia.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04071847
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Devyani Nanduri
Query!
Address
0
0
Abbott Medical Devices Neuromodulation
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Natalie Brill, PhD
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+15122864383
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04071847
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