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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02112253
Registration number
NCT02112253
Ethics application status
Date submitted
22/03/2014
Date registered
11/04/2014
Date last updated
18/05/2021
Titles & IDs
Public title
Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome
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Scientific title
Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome - A Pilot Study
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Secondary ID [1]
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2012-120
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tourette's Syndrome
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Condition category
Condition code
Mental Health
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Other mental health disorders
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Neurological
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Other neurological disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Deep brain stimulator ventral electrode up to 2 mA - The ventral contact within the anterior globus pallidus interna near the ansa lenticularis is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 2 mA amplitude is reached; whichever comes first.
Experimental: Deep brain stimulator ventral electrode up to 3 mA - The ventral contact within the anterior globus pallidus interna near the ansa lenticularis is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 3 mA amplitude is reached; whichever comes first.
Experimental: Deep brain stimulator dorsal electrode up to 2 mA - The dorsal contact within the superior half of the anterior globus pallidus interna is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 2 mA amplitude is reached; whichever comes first.
Experimental: Deep brain stimulator dorsal electrode up to 3 mA - The dorsal contact within the superior half of the anterior globus pallidus interna is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 3 mA amplitude is reached; whichever comes first.
Active comparator: Deep brain stimulator empirical programming - Any of the four electrode contacts on each of the two deep brain stimulation leads can be activated in any combination with any amplitude, frequency or pulse width settings to achieve optimized clinical control of motor tics whilst minimizing side effects. Both programmer and patient may be unblinded. The assessors are blinded to stimulation settings.
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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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Yale Global Tic Severity Scale (YGTSS)
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Assessment method [1]
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Performed before surgery.
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Timepoint [1]
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At baseline
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Primary outcome [2]
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Yale Global Tic Severity Scale (YGTSS)
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Assessment method [2]
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At the end of the first of four three-month randomized blinded stimulation periods.
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Timepoint [2]
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3 months
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Primary outcome [3]
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Yale Global Tic Severity Scale (YGTSS)
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Assessment method [3]
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At the end of the second of four three-month randomized blinded stimulation periods.
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Timepoint [3]
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6 months
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Primary outcome [4]
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Yale Global Tic Severity Scale (YGTSS)
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Assessment method [4]
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At the end of the third of four three-month randomized blinded stimulation periods.
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Timepoint [4]
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9 months
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Primary outcome [5]
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Yale Global Tic Severity Scale (YGTSS)
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Assessment method [5]
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At the end of the last of four three-month randomized blinded stimulation periods.
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Timepoint [5]
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12 months
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Primary outcome [6]
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Yale Global Tic Severity Scale (YGTSS)
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Assessment method [6]
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At the end of the 6 month non-randomized empirical stimulation period.
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Timepoint [6]
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18 months
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Secondary outcome [1]
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Modified Rush Video Rating Scale and tic counts
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Assessment method [1]
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Performed before surgery.
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Timepoint [1]
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At baseline
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Secondary outcome [2]
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Modified Rush Video Rating Scale and tic counts
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Assessment method [2]
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At the end of the first of four three-month randomized blinded stimulation periods.
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Timepoint [2]
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3 months
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Secondary outcome [3]
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Modified Rush Video Rating Scale and tic counts
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Assessment method [3]
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At the end of the second of four three-month randomized blinded stimulation periods.
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Modified Rush Video Rating Scale and tic counts
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Assessment method [4]
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At the end of the third of four three-month randomized blinded stimulation periods.
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Timepoint [4]
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9 months
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Secondary outcome [5]
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Modified Rush Video Rating Scale and tic counts
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Assessment method [5]
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0
At the end of the last of four three-month randomized blinded stimulation periods.
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Timepoint [5]
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12 months
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Secondary outcome [6]
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Modified Rush Video Rating Scale and tic counts
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Assessment method [6]
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At the end of the 6 month non-randomized empirical stimulation period.
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Timepoint [6]
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18 months
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Secondary outcome [7]
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Tourette's syndrome symptom list
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Assessment method [7]
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Performed before surgery.
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Timepoint [7]
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At baseline
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Secondary outcome [8]
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Tourette's syndrome symptom list
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Assessment method [8]
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At the end of the first of four three-month randomized blinded stimulation periods.
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Timepoint [8]
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3 months
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Secondary outcome [9]
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Tourette's syndrome symptom list
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Assessment method [9]
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At the end of the second of four three-month randomized blinded stimulation periods.
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Timepoint [9]
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6 months
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Secondary outcome [10]
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Tourette's syndrome symptom list
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Assessment method [10]
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At the end of the third of four three-month randomized blinded stimulation periods.
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Timepoint [10]
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9 months
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Secondary outcome [11]
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Tourette's syndrome symptom list
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Assessment method [11]
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At the end of the third of four three-month randomized blinded stimulation periods.
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Timepoint [11]
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12 months
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Secondary outcome [12]
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Tourette's syndrome symptom list
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Assessment method [12]
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At the end of the 6 month non-randomized empirical stimulation period.
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Timepoint [12]
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18 months
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Secondary outcome [13]
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Short Form 36
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Assessment method [13]
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Quality of life outcome measure. Performed before surgery.
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Timepoint [13]
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At baseline
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Secondary outcome [14]
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Short Form 36
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Assessment method [14]
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Quality of life outcome measure. At the end of the first of four three-month randomized blinded stimulation periods.
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Timepoint [14]
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3 months
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Secondary outcome [15]
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Short Form 36
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Assessment method [15]
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Quality of life outcome measure. At the end of the second of four three-month randomized blinded stimulation periods.
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Timepoint [15]
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6 months
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Secondary outcome [16]
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Short Form 36
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Assessment method [16]
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Quality of life outcome measure. At the end of the third of four three-month randomized blinded stimulation periods.
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Timepoint [16]
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9 months
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Secondary outcome [17]
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Short Form 36
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Assessment method [17]
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Quality of life outcome measure. At the end of the last of four three-month randomized blinded stimulation periods.
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Timepoint [17]
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12 months
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Secondary outcome [18]
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Short Form 36
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Assessment method [18]
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At the end of the 6 month non-randomized empirical stimulation period.
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Timepoint [18]
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18 months
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Secondary outcome [19]
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Montreal Cognitive Assessment (MoCA)
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Assessment method [19]
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Performed before surgery.
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Timepoint [19]
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At baseline
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Secondary outcome [20]
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Montreal Cognitive Assessment (MoCA)
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Assessment method [20]
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At the end of the first of four three-month randomized blinded stimulation periods.
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Timepoint [20]
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3 months
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Secondary outcome [21]
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Montreal Cognitive Assessment (MoCA)
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Assessment method [21]
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At the end of the second of four three-month randomized blinded stimulation periods.
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Timepoint [21]
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6 months
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Secondary outcome [22]
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Montreal Cognitive Assessment (MoCA)
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Assessment method [22]
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At the end of the third of four three-month randomized blinded stimulation periods.
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Timepoint [22]
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9 months
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Secondary outcome [23]
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0
Montreal Cognitive Assessment (MoCA)
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Assessment method [23]
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At the end of the last of four three-month randomized blinded stimulation periods.
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Timepoint [23]
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12 months
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Secondary outcome [24]
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Montreal Cognitive Assessment (MoCA)
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Assessment method [24]
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At the end of the 6 month non-randomized empirical stimulation period.
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Timepoint [24]
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18 months
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Secondary outcome [25]
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Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
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Assessment method [25]
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Performed before surgery.
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Timepoint [25]
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At baseline
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Secondary outcome [26]
0
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Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
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Assessment method [26]
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At the end of the first of four three-month randomized blinded stimulation periods.
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Timepoint [26]
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3 months
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Secondary outcome [27]
0
0
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
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Assessment method [27]
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At the end of the second of four three-month randomized blinded stimulation periods.
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Timepoint [27]
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6 months
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Secondary outcome [28]
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0
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
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Assessment method [28]
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At the end of the third of four three-month randomized blinded stimulation periods.
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Timepoint [28]
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9 months
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Secondary outcome [29]
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0
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
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Assessment method [29]
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At the end of the last of four three-month randomized blinded stimulation periods.
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Timepoint [29]
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12 months
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Secondary outcome [30]
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Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
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Assessment method [30]
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At the end of the 6 month non-randomized empirical stimulation period.
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Timepoint [30]
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18 months
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Secondary outcome [31]
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Adverse effects list
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Assessment method [31]
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Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the first of four three-month randomized blinded stimulation periods.
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Timepoint [31]
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3 months
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Secondary outcome [32]
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Adverse effects list
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Assessment method [32]
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Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the second of four three-month randomized blinded stimulation periods.
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Timepoint [32]
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6 months
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Secondary outcome [33]
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Adverse effects list
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Assessment method [33]
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Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the third of four three-month randomized blinded stimulation periods.
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Timepoint [33]
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9 months
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Secondary outcome [34]
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Adverse effects list
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Assessment method [34]
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Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the last of four three-month randomized blinded stimulation periods.
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Timepoint [34]
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12 months
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Secondary outcome [35]
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Adverse effects list
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Assessment method [35]
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Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the 6 month non-randomized empirical stimulation period.
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Timepoint [35]
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12 months
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Eligibility
Key inclusion criteria
* Age 14 to 60 years
* Patient Group with Tourette's syndrome - severe and resistant to medical treatment including antipsychotic medication
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Minimum age
14
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Surgical contraindications to deep brain stimulation surgery
* Major Depressive Episode within the previous 6 months
* Schizophrenia or other psychotic disorder
* Personality disorder impairing ability to reliably comply with study protocol
* Significant cognitive impairment
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/03/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
14/05/2021
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Actual
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Sample size
Target
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Accrual to date
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Final
0
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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6009 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Western Australia
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Address
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Country
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Other collaborator category [1]
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0
Other
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Name [1]
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Sir Charles Gairdner Hospital
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Address [1]
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0
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Perron Institute for Neurological and Translational Science
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Address [2]
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Country [2]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
The motor tics associated with Tourette's syndrome may be reduced with deep brain stimulation of the anterior globus pallidus. The best area within this brain region and the best stimulation device settings are currently unknown. This is a study in which deep versus superficial electrode contact positions and two different amplitudes of stimulation are compared under scientific conditions. The hypothesis is that one contact position/stimulation amplitude combination will provide a better outcome than the others. Each study participant receives each of four different anatomical position/stimulation amplitude setting combinations over a 12 month period in randomized order followed by a 6-month period of trial-and-error device programming to optimize control of motor tics. Motor tics, potential side effects, daily functioning and quality of life are assessed at the end of each trial stimulation period. At the end of the study, the study participant continues to have long-term deep brain stimulation treatment with whatever settings provide the most relief.
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Trial website
https://clinicaltrials.gov/study/NCT02112253
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christopher Lind, FRACS
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Address
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The University of Western Australia
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Country
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Phone
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Fax
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Email
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0
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Contact person for public queries
Name
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Address
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Country
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0
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02112253
Download to PDF