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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/NCT06138808




Registration number
NCT06138808
Ethics application status
Date submitted
14/11/2023
Date registered
18/11/2023
Date last updated
3/04/2024

Titles & IDs
Public title
5-SENSE Score Validation Study
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
Secondary ID [1] 0 0
Pro00113692
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy Intractable 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG
Timepoint [1] 0 0
At time of SEEG, up to approximately 1 month
Primary outcome [2] 0 0
Sensitivity of the 5-SENSE score for the identification of a focal SOZ on SEEG
Timepoint [2] 0 0
At time of SEEG, up to approximately 1 month
Primary outcome [3] 0 0
Positive predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
Timepoint [3] 0 0
At time of SEEG, up to approximately 1 month
Primary outcome [4] 0 0
Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
Timepoint [4] 0 0
At time of SEEG, up to approximately 1 month
Secondary outcome [1] 0 0
Specificity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG
Timepoint [1] 0 0
At time of SEEG, up to approximately 1 month
Secondary outcome [2] 0 0
Sensitivity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG
Timepoint [2] 0 0
At time of SEEG, up to approximately 1 month
Secondary outcome [3] 0 0
Concordance of the 5-SENSE Score with the decision whether to proceed with SEEG or not
Timepoint [3] 0 0
At enrollment

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)
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- no telemetry/scalp EEG in center

- no protocol MRI in center

- subdural/GRID electrodes

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Monash University - Melbourne
Recruitment hospital [2] 0 0
Mater Health - Brisbane
Recruitment hospital [3] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
3800 - Melbourne
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Austria
State/province [5] 0 0
Salzburg
Country [6] 0 0
Canada
State/province [6] 0 0
Nova Scotia
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Czechia
State/province [8] 0 0
Brno
Country [9] 0 0
Denmark
State/province [9] 0 0
Aarhus
Country [10] 0 0
France
State/province [10] 0 0
Grenoble
Country [11] 0 0
France
State/province [11] 0 0
Marseille
Country [12] 0 0
Germany
State/province [12] 0 0
Freiburg
Country [13] 0 0
Japan
State/province [13] 0 0
Kyoto
Country [14] 0 0
Romania
State/province [14] 0 0
Bucharest
Country [15] 0 0
Spain
State/province [15] 0 0
Valencia
Country [16] 0 0
Switzerland
State/province [16] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Other
Name
Duke University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Christian Doppler University Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06138808
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Birgit Frauscher, MD PD
Address 0 0
Duke University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06138808