5-SENSE Score Validation Study

• Sponsor: Duke University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06138808
• Collaborator: Christian Doppler University Hospital (Other)
• Enrollment: 400
• Locations: 22
• Anticipated Duration (Months): 24
• Patients Per Site: 18.2
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Intractable	Other: Stereoelectroencephalography (SEEG)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official 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
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2025
• Anticipated Study Completion Date: Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Stereoelectroencephalography (SEEG) Participants undergoing SEEG as part of standard of care.	Other: Stereoelectroencephalography (SEEG); Participants will under Stereoelectroencephalography (SEEG) as part of standard of care. This is not assigned by the protocol.
Control Group Participants not undergoing SEEG as part of standard of care.

Outcome Measures

Primary Outcome Measures

1. Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG [At time of SEEG, up to approximately 1 month]

   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.

2. Sensitivity of the 5-SENSE score for the identification of a focal SOZ on SEEG [At time of SEEG, up to approximately 1 month]

   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.

3. Positive predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG [At time of SEEG, up to approximately 1 month]

   Measured for participants undergoing SEEG

4. Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG [At time of SEEG, up to approximately 1 month]

   Measured for participants undergoing SEEG

Secondary Outcome Measures

1. Specificity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG [At time of SEEG, up to approximately 1 month]

   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

2. Sensitivity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG [At time of SEEG, up to approximately 1 month]

   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

3. Concordance of the 5-SENSE Score with the decision whether to proceed with SEEG or not [At enrollment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Exclusion Criteria:

• no telemetry/scalp EEG in center

• no protocol MRI in center

• subdural/GRID electrodes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida College of Medicine	Gainesville	Florida	United States	32610
2	Northwestern University	Chicago	Illinois	United States	60611
3	Beth Israel/Harvard Program	Boston	Massachusetts	United States	02215
4	Duke University Health System	Durham	North Carolina	United States	27710
5	Presbyterian-Shadyside Hospital	Pittsburgh	Pennsylvania	United States	15232
6	Monash University	Melbourne	Victoria	Australia	3800
7	University of Queensland	Brisbane		Australia
8	Alfred Health	Melbourne		Australia
9	Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg	Salzburg		Austria	5020
10	Dalhousie Universiry and Hospital	Dalhousie	Nova Scotia	Canada
11	Wester University	London	Ontario	Canada
12	Departmet of Neurology, Masaryk University Brno	Brno		Czechia
13	Danish Epilepsy Centre, Aarhus Universitets Hospital	Aarhus		Denmark	8200
14	Grenoble Institute of Neurosciences, Centre Hospitalier Universitaire Grenoble Alpes	Grenoble		France
15	Epilepsy Department University Hospitals of Marseille	Marseille		France
16	Epilepsy Department; Universitätsklinikum Erlangen	Erlangen		Germany
17	Epilepsy Centre, University Hospital Freiburg	Freiburg		Germany
18	University School of Medicine Kyoto	Kyoto		Japan	606-8303
19	"Carol Davila" University of Medicine and Pharmacy	Bucharest		Romania
20	Hospital Universitario y Politecnico La Fe	Valencia		Spain
21	Department of Clinical Neurosciences chez CHUV; Centre Hospitalier Universitaire Vaudois	Lausanne		Switzerland
22	University College London Hospitals, NHS Foundation Trust	London		United Kingdom

Sponsors and Collaborators

• Duke University
• Christian Doppler University Hospital

Investigators

• Principal Investigator: Birgit Frauscher, MD PD, Duke University
• Principal Investigator: Alexandra Astner-Rohracher, Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT06138808
• Other Study ID Numbers: Pro00113692
• First Posted: Nov 18, 2023
• Last Update Posted: Nov 18, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Duke University: epilepsy; surgery; stereo-electroencephalography
• Additional relevant MeSH terms: Epilepsy; Drug Resistant Epilepsy

Study Results

No Results Posted as of Nov 18, 2023