Epilepsy IntractableNCT06138808
5-SENSE Score Validation Study
An observational study of Epilepsy Intractable, run by Duke University at 19 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Epilepsy Intractable
- What is being tested?
- Stereoelectroencephalography (SEEG)
- How many people
- 400 participants
- Where
- 19 sitesin 12 countries
- Study dates
- 9 Jan 2024to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients will be prospectively recruited at 20-25 epilepsy centers from North America, Europe, Australia and Asia.
Who may be able to join
- 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)
Who cannot join
- no telemetry/scalp EEG in center
- no protocol MRI in center
- subdural/GRID electrodes
Trial locations and contacts
19 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 12 countries
United States4 sites
Northwestern University
Chicago, Illinois, 60611
Duke University Health System
Durham, North Carolina, 27710
University of Florida College of Medicine
Gainesville, Florida, 32610
Presbyterian-Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Australia3 sites
Mater Health
Brisbane
Monash University
Melbourne, Victoria, 3800
Alfred Health
Melbourne
Canada2 sites
Dalhousie Universiry and Hospital
Dalhousie, Nova Scotia
Wester University
London, Ontario
France2 sites
Grenoble Institute of Neurosciences, Centre Hospitalier Universitaire Grenoble Alpes
Grenoble
Epilepsy Department University Hospitals of Marseille
Marseille
Austria1 site
Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg
Salzburg, 5020
Denmark1 site
Danish Epilepsy Centre, Aarhus Universitets Hospital
Aarhus, 8200
Germany1 site
Epilepsy Centre, University Hospital Freiburg
Freiburg im Breisgau
Switzerland1 site
Department of Clinical Neurosciences chez CHUV; Centre Hospitalier Universitaire Vaudois
Lausanne
About this study
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
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.
- Conditions
- Epilepsy Intractable
- Being tested
- Stereoelectroencephalography (SEEG)
- Keywords
- epilepsy, surgery, stereo-electroencephalography
- Medical subject headings
- Drug Resistant Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereoelectroencephalography (SEEG)Other
Participants will under Stereoelectroencephalography (SEEG) as part of standard of care. This is not assigned by the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Stereoelectroencephalography (SEEG) | Participants undergoing SEEG as part of standard of care. Receives: Other: Stereoelectroencephalography (SEEG) | |
| Control Group | Participants not undergoing SEEG as part of standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG
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.
Measured: At time of SEEG, up to approximately 1 month
Sensitivity of the 5-SENSE score for the identification of a focal SOZ on SEEG
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.
Measured: At time of SEEG, up to approximately 1 month
Positive predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
Measured for participants undergoing SEEG
Measured: At time of SEEG, up to approximately 1 month
Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
Measured for participants undergoing SEEG
Measured: At time of SEEG, up to approximately 1 month
Secondary outcomes (3)
Specificity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG
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
Measured: At time of SEEG, up to approximately 1 month
Sensitivity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG
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
Measured: At time of SEEG, up to approximately 1 month
Concordance of the 5-SENSE Score with the decision whether to proceed with SEEG or not
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start9 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epilepsy IntractableStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Birgit Frauscher, MD PD, Principal investigator, Duke UniversityAlexandra Astner-Rohracher, Principal investigator, Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138808
- Sponsor's protocol ID
- Pro00113692
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Astner-Rohracher A, Ho A, Archer J, Bartolomei F, Brazdil M, Cacic Hribljan M, Castellano J, Dolezalova I, Fabricius ME, Garces-Sanchez M, Hammam K, Ikeda A, Ikeda K, Kahane P, Kalamangalam G, Kalss G, Khweileh M, Kobayashi K, Kwan P, Laing JA, Leitinger M, Lhatoo S, Makhalova J, McGonigal A, Mindruta I, Mizera MM, Neal A, Oane I, Parikh P, Perucca P, Pizzo F, Rocamora R, Ryvlin P, San Antonio Arce V, Schuele S, Schulze-Bonhage A, Suller Marti A, Urban A, Villanueva V, Vilella Bertran L, Whatley B, Beniczky S, Trinka E, Zimmermann G, Frauscher B. Prognostic value of the 5-SENSE Score to predict focality of the seizure-onset zone as assessed by stereoelectroencephalography: a prospective international multicentre validation study. BMJ Neurol Open. 2024 Aug 21;6(2):e000765. doi: 10.1136/bmjno-2024-000765. eCollection 2024.
PubMed 39175939
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06138808
- Acronym / sponsor ID
- Pro00113692
- Conditions
- Epilepsy Intractable
- Keywords
- epilepsy, surgery, stereo-electroencephalography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stereoelectroencephalography (SEEG) | – | Other: Stereoelectroencephalography (SEEG)Participants undergoing SEEG as part of standard of care. |
| Control Group | – | –Participants not undergoing SEEG as part of standard of care. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients will be prospectively recruited at 20-25 epilepsy centers from North America, Europe, Australia and Asia.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- no telemetry/scalp EEG in center
- no protocol MRI in center
- subdural/GRID electrodes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereoelectroencephalography (SEEG)Participants will under Stereoelectroencephalography (SEEG) as part of standard of care. This is not assigned by the protocol. | Other | Stereoelectroencephalography (SEEG) |
Primary outcome
Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG
Time frame: 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.
Sensitivity of the 5-SENSE score for the identification of a focal SOZ on SEEG
Time frame: 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.
Positive predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
Time frame: At time of SEEG, up to approximately 1 month
Measured for participants undergoing SEEG
Negative predictive value of the 5-SENSE score for the identification of a focal SOZ on SEEG
Time frame: At time of SEEG, up to approximately 1 month
Measured for participants undergoing SEEG
3 secondary outcomes
Specificity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG
Time frame: At time of SEEG, up to approximately 1 month
Sensitivity of the 5-SENSE score augmented by information from auxiliary diagnostic methods for the identification of a focal SOZ on SEEG
Time frame: At time of SEEG, up to approximately 1 month
Concordance of the 5-SENSE Score with the decision whether to proceed with SEEG or not
Time frame: At enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 39175939Astner-Rohracher A, Ho A, Archer J, Bartolomei F, Brazdil M, Cacic Hribljan M, Castellano J, Dolezalova I, Fabricius ME, Garces-Sanchez M, Hammam K, Ikeda A, Ikeda K, Kahane P, Kalamangalam G, Kalss G, Khweileh M, Kobayashi K, Kwan P, Laing JA, Leitinger M, Lhatoo S, Makhalova J, McGonigal A, Mindruta I, Mizera MM, Neal A, Oane I, Parikh P, Perucca P, Pizzo F, Rocamora R, Ryvlin P, San Antonio Arce V, Schuele S, Schulze-Bonhage A, Suller Marti A, Urban A, Villanueva V, Vilella Bertran L, Whatley B, Beniczky S, Trinka E, Zimmermann G, Frauscher B. Prognostic value of the 5-SENSE Score to predict focality of the seizure-onset zone as assessed by stereoelectroencephalography: a prospective international multicentre validation study. BMJ Neurol Open. 2024 Aug 21;6(2):e000765. doi: 10.1136/bmjno-2024-000765. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Birgit Frauscher, MD PD principal investigator
Duke University
Alexandra Astner-Rohracher principal investigator
Christian Doppler University Hospital Paracelsus Medical University Salzburg and Centre for Cognitive Neuroscience Salzburg
19 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy Intractable, run by Duke University at 19 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Australia, Canada, France, Austria and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of the 5-SENSE score for the identification of a focal SOZ on SEEG (time frame: At time of SEEG, up to approximately 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06138808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.