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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06138808
Registration number
NCT06138808
Ethics application status
Date submitted
14/11/2023
Date registered
18/11/2023
Titles & IDs
Public title
5-SENSE Score Validation Study
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Scientific title
Prognostic Value of the 5-SENSE Score to Predict Focality of the Seizure-onset Zone as Assessed by Stereo-electroencephalography - a Prospective Multicenter Validation Study
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Secondary ID [1]
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Pro00113692
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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:
Epilepsy Intractable
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Condition category
Condition code
Neurological
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Epilepsy
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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
Other interventions - Stereoelectroencephalography (SEEG)
Stereoelectroencephalography (SEEG) - Participants undergoing SEEG as part of standard of care.
Control Group - Participants not undergoing SEEG as part of standard of care.
Other interventions: Stereoelectroencephalography (SEEG)
Participants will under Stereoelectroencephalography (SEEG) as part of standard of care. This is not assigned by the protocol.
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Intervention code [1]
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Other interventions
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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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Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG
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Assessment method [1]
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Prospective validation of the predictive value of the 5-SENSE score to identify a focal seizure onset zone (SOZ) in an independent patient sample. Measured for participants undergoing SEEG.
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Timepoint [1]
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At time of SEEG, up to approximately 1 month
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Primary outcome [2]
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Sensitivity of the 5-SENSE score for the identification of a focal SOZ on SEEG
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Assessment method [2]
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Prospective validation of the predictive value of the 5-SENSE score to identify a focal seizure onset zone (SOZ) in an independent patient sample. Measured for participants undergoing SEEG.
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Timepoint [2]
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At time of SEEG, up to approximately 1 month
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Primary outcome [3]
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Positive predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
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Assessment method [3]
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Measured for participants undergoing SEEG
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Timepoint [3]
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At time of SEEG, up to approximately 1 month
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Primary outcome [4]
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Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
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Assessment method [4]
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Measured for participants undergoing SEEG
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Timepoint [4]
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At time of SEEG, up to approximately 1 month
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Secondary outcome [1]
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Specificity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG
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Assessment method [1]
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For participants undergoing SEEG, information from auxiliary diagnostic methods, performed routinely during presurgical evaluation, namely FDG-PET, electrical source imaging (ESI) and/or magnetic source imaging (MSI) and ictal HMPAO-SPECT will be analyzed. The investigators will assess whether addition of those variables to the 5-SENSE Score could enhance score performance with higher specificity for identifying a focal SOZ
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Timepoint [1]
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At time of SEEG, up to approximately 1 month
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Secondary outcome [2]
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Sensitivity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG
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Assessment method [2]
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For participants undergoing SEEG, information from auxiliary diagnostic methods, performed routinely during presurgical evaluation, namely FDG-PET, electrical source imaging (ESI) and/or magnetic source imaging (MSI) and ictal HMPAO-SPECT will be analyzed. The investigators will assess whether addition of those variables to the 5-SENSE Score could enhance score performance with higher sensitivity for identifying a focal SOZ
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Timepoint [2]
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At time of SEEG, up to approximately 1 month
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Secondary outcome [3]
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Concordance of the 5-SENSE Score with the decision whether to proceed with SEEG or not
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Assessment method [3]
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Before SEEG, the decision whether to proceed with SEEG or not is made blinded from the 5- SENSE Score in a Multidisciplinary Team Discussion (MTD). Following the decision, the 5-SENSE Score will be calculated for each participant by the principal investigator. Concordance of the 5-SENSE Score with the decision made in the MTD will be assessed.
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Timepoint [3]
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At enrollment
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Eligibility
Key inclusion criteria
* patients aged 15 years or older in whom no direct surgical approach can be offered and who are discussed in the multidisciplinary team discussion
* availability of complete non-invasive presurgical work-up (including high-resolution MRI according to the in-center epilepsy protocol, video-telemetry with the recording of a minimum of one habitual clinic and EEG seizure, available as original files for review)
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Minimum age
15
Years
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Maximum age
No limit
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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
* no telemetry/scalp EEG in center
* no protocol MRI in center
* subdural/GRID electrodes
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
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Actual
9/01/2024
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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
1/11/2025
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash University - Melbourne
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Recruitment hospital [2]
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Mater Health - Brisbane
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Recruitment hospital [3]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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3800 - Melbourne
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Recruitment postcode(s) [2]
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- Brisbane
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Recruitment postcode(s) [3]
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- Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Illinois
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Country [3]
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United States of America
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State/province [3]
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North Carolina
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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Austria
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State/province [5]
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Salzburg
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Country [6]
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Canada
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State/province [6]
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Nova Scotia
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Country [7]
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Canada
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State/province [7]
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Ontario
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Country [8]
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Czechia
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State/province [8]
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Brno
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Country [9]
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Denmark
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State/province [9]
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Aarhus
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Country [10]
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France
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State/province [10]
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Grenoble
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Country [11]
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France
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State/province [11]
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Marseille
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Country [12]
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Germany
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State/province [12]
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Freiburg
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Country [13]
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Japan
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State/province [13]
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Kyoto
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Country [14]
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Romania
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State/province [14]
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Bucharest
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Country [15]
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Spain
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State/province [15]
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Valencia
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Country [16]
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Switzerland
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State/province [16]
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Lausanne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Duke University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Christian Doppler University Hospital
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess how well a new scoring system called the 5-SENSE score can predict where seizures start in the brain using Stereoelectroencephalography (SEEG). The 5-SENSE Score is a 5-point score based on routine presurgical work-up, designed to assist in predicting whether SEEG can identify a focal seizure onset zone, thereby sparing patients the risk of undergoing this invasive diagnostic procedure.
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Trial website
https://clinicaltrials.gov/study/NCT06138808
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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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Birgit Frauscher, MD PD
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Address
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Duke University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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/NCT06138808