EpilepsyISD SEEGNCT03094312
Evaluation of the Risk of Cognitive Deficit After Surgery of Epilepsy by Dynamic Spectral Imaging (ISD) of the Cognitive Functions in Patients Explored in StereoElectroEncephaloGraphy (SEEG)
A study testing Dynamic Spectral Imaging (ISD) in people with Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Epilepsy affects between 0.5 and 0.7% of the European population. Despite the availability of numerous drug treatments, one third of patients still have seizures, which are associated with significant cognitive and social complications and excess mortality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Dynamic Spectral Imaging (ISD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2017to 23 Jan 2030
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient adult (18-65 y/o) without legal protection measures
- Patient with a drug-resistant focal epilepsy
- Patient with a SEEG exploration as part of pre-surgical assessment of epilepsy
- patient with a consent form signed
- Intellectual capacities compatible with cognitive tasks and the signing of informed consent
- Affiliation to the social security
Who cannot join
- Pregnant women: this is already a contraindication to the realization of a SEEG study
- Subjects under 18 years of age or over 65 years of age
- Patient not suffering from EFPR, or not scheduled for SEEG
- Intellectual capacities incompatible with the cognitive tasks and / or the signature of a consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne-Laure CHARLOIS contact
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Bron, 69500
Sylvain RHEIMS, MD, 472359343 ext. +33, sylvain.rheims@chu-lyon.fr
Anne-Laure CHARLOIS
About this study
Epilepsy affects between 0.5 and 0.7% of the European population. Despite the availability of numerous drug treatments, one third of patients still have seizures, which are associated with significant cognitive and social complications and excess mortality. In these patients, surgical treatment to remove the epileptogenic zone (EZ), the region of the brain responsible for seizures, is the only approach that can allow control of the disease. However, before investigating this surgery, investigations have to answer two questions: (i) what is the location and extension of the EZ and (ii) what functional risks, both motor and cognitive, would represent the resection of this Cortical region? As it is a functional surgery, it is in fact inconceivable that the surgery will result in an over-handicap. For these reasons, all candidates for surgery benefit from a complete assessment including imaging examinations, a neuropsychological assessment and a long-term video-EEG recording to record seizures. Nevertheless, in some patients, this assessment does not give us a formal answer. In these subjects, it is then necessary to carry out a second step, consisting of an invasive exploration by implantation of intracerebral electrodes during a stereoencephalography (SEEG). Due to its temporal and spatial resolution, the SEEG allows, besides the precise determination of the EZ, to carry out a functional mapping of the cortical regions likely to be included in cortectomy. Conventionally, this mapping is carried out on the basis of the cortical electrical stimulations applied to the implanted electrodes. If this approach is very robust for exploring primary functions such as motor skills or language, it cannot be used to evaluate more complex cognitive tasks such as face recognition or attention Effective cognitive treatment on a daily basis. This has led to the development in recent years, in Lyon and Grenoble, of a complementary approach to cerebral stimulation: dynamic spectral imaging (ISD). Numerous experimental paradigms have demonstrated that the realization of a cognitive task associates with the generation within the cortical regions involved in its treatment of a particular cortical activity. This activity is characterized by oscillations of the cortical rhythm in high frequencies (> 30 Hz), called gamma activities. The ISD thus consists in mapping this gamma activity during various cognitive tasks, thus making it possible to study more widely the complexity of the cognitive functions. Correlations between gamma activity and cognitive tasks have so far been exclusively performed in the non-epileptic cortex explored at the periphery of the EA during SEEG. Nevertheless, the cortical oscillatory pattern study associated with a specific cognitive task within the EZ could better anticipate complex cognitive deficits that could be generated by the resection of a cortical region.
The main objective of this project is to establish the predictive character of the gamma cortical oscillatory pattern associated with a specific cognitive task on the risk of occurrence of a cognitive disorder after surgery of epilepsy.
- Conditions
- Epilepsy
- Being tested
- Dynamic Spectral Imaging (ISD)
- Keywords
- SEEG, ISD, cognitive disorder, epilepsy surgery
- Medical subject headings
- Epilepsy, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Spectral Imaging (ISD)Procedure or surgery
cerebral stimulation: dynamic spectral imaging (ISD)
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Spectral Imaging (ISD) | Experimental | Evaluation of cognitive functions by ISD Receives: Procedure: Dynamic Spectral Imaging (ISD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictive character of the cortical gamma oscillatory pattern associated with a specific cognitive task on the risk of occurrence of a cognitive disorder after epilepsy surgery
Relation between the presence in the epileptogenic zone of a gamma activation in at least 1 of the cognitive tasks performed during the ISD and the occurrence of a postoperative neuropsychological deficit (Wilcoxon test)
Measured: 12 months post-surgery compare to preoperative assessment (SEEG)
Secondary outcomes (5)
database on the dynamics of large cerebral networks underlying the main cognitive functions
Comparison of mapping of pre-surgical gamma activity with preoperative neu-ropsychological evaluation
Measured: pre-surgical assessment (SEEG)
spatio-temporal organization of these networks with that predicted by fMRI
Pre-surgical comparison of the performances for the functional cartography of gamma activity performed during SEEG, fMRI and cortical stimulation at preoperative assessment.
Measured: preoperative assessment (SEEG, fMRI and cortical stimulations)
effect of intracerebral electrical stimulations
Pre-surgical comparison of the performances for the functional cartography of gamma activity performed during SEEG, fMRI and cortical stimulation at preoperative assessment.
Measured: preoperative assessment (SEEG, fMRI and cortical stimulations)
macro-electrophysiological recordings
The relation between the presence in the epileptogenic zone of an activation in the other frequency bands (theta, alpha, beta) in at least 1 of the cognitive tasks performed during the ISD and the occurrence of a post neuropsychological deficit
Measured: 12 months post-surgery compare to preoperative assessment (SEEG)
micro-electrophysiological recordings
The relation between the presence in the epileptogenic zone of an activation in the other frequency bands (theta, alpha, beta) in at least 1 of the cognitive tasks performed during the ISD and the occurrence of a post neuropsychological deficit
Measured: 12 months post-surgery compare to preoperative assessment (SEEG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start23 Jun 2017
- Primary completion23 Jan 2030 (estimated)
- Study completion23 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain RHEIMS, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094312
- Sponsor's protocol ID
- 69HCL16_0644
- Other IDs
- 2017-A00464-49
- Acronym
- ISD SEEG
- Status last verified
- Jan 2026
- First submitted
- 9 Mar 2017
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Risk of Cognitive Deficit After Surgery of Epilepsy by Dynamic Spectral Imaging (ISD) of the Cognitive Functions in Patients Explored in StereoElectroEncephaloGraphy (SEEG)
- ClinicalTrials.gov ID
- NCT03094312
- Acronym / sponsor ID
- ISD SEEG / 69HCL16_0644
- Conditions
- Epilepsy
- Keywords
- SEEG, ISD, cognitive disorder, epilepsy surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 23 Jan 2030 (estimated)
- Study completion
- 23 Jan 2030 (estimated)
- First posted
- 29 Mar 2017 (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.
Epilepsy affects between 0.5 and 0.7% of the European population. Despite the availability of numerous drug treatments, one third of patients still have seizures, which are associated with significant cognitive and social complications and excess mortality. In these patients, surgical treatment to remove the epileptogenic zone (EZ), the region of the brain responsible for seizures, is the only approach that can allow control of the disease. However, before investigating this surgery, investigations have to answer two questions: (i) what is the location and extension of the EZ and (ii) what functional risks, both motor and cognitive, would represent the resection of this Cortical region? As it is a functional surgery, it is in fact inconceivable that the surgery will result in an over-handicap. For these reasons, all candidates for surgery benefit from a complete assessment including imaging examinations, a neuropsychological assessment and a long-term video-EEG recording to record seizures. Nevertheless, in some patients, this assessment does not give us a formal answer. In these subjects, it is then necessary to carry out a second step, consisting of an invasive exploration by implantation of intracerebral electrodes during a stereoencephalography (SEEG). Due to its temporal and spatial resolution, the SEEG allows, besides the precise determination of the EZ, to carry out a functional mapping of the cortical regions likely to be included in cortectomy. Conventionally, this mapping is carried out on the basis of the cortical electrical stimulations applied to the implanted electrodes. If this approach is very robust for exploring primary functions such as motor skills or language, it cannot be used to evaluate more complex cognitive tasks such as face recognition or attention Effective cognitive treatment on a daily basis. This has led to the development in recent years, in Lyon and Grenoble, of a complementary approach to cerebral stimulation: dynamic spectral imaging (ISD). Numerous experimental paradigms have demonstrated that the realization of a cognitive task associates with the generation within the cortical regions involved in its treatment of a particular cortical activity. This activity is characterized by oscillations of the cortical rhythm in high frequencies (> 30 Hz), called gamma activities. The ISD thus consists in mapping this gamma activity during various cognitive tasks, thus making it possible to study more widely the complexity of the cognitive functions. Correlations between gamma activity and cognitive tasks have so far been exclusively performed in the non-epileptic cortex explored at the periphery of the EA during SEEG. Nevertheless, the cortical oscillatory pattern study associated with a specific cognitive task within the EZ could better anticipate complex cognitive deficits that could be generated by the resection of a cortical region.
The main objective of this project is to establish the predictive character of the gamma cortical oscillatory pattern associated with a specific cognitive task on the risk of occurrence of a cognitive disorder after surgery of epilepsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dynamic Spectral Imaging (ISD) | Experimental | Procedure: Dynamic Spectral Imaging (ISD)Evaluation of cognitive functions by ISD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patient adult (18-65 y/o) without legal protection measures
- Patient with a drug-resistant focal epilepsy
- Patient with a SEEG exploration as part of pre-surgical assessment of epilepsy
- patient with a consent form signed
- Intellectual capacities compatible with cognitive tasks and the signing of informed consent
Key exclusion criteria (4 listed)
- Pregnant women: this is already a contraindication to the realization of a SEEG study
- Subjects under 18 years of age or over 65 years of age
- Patient not suffering from EFPR, or not scheduled for SEEG
- Intellectual capacities incompatible with the cognitive tasks and / or the signature of a consent
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 |
|---|---|---|
| Dynamic Spectral Imaging (ISD)cerebral stimulation: dynamic spectral imaging (ISD) | Procedure or surgery | Dynamic Spectral Imaging (ISD) |
Primary outcome
predictive character of the cortical gamma oscillatory pattern associated with a specific cognitive task on the risk of occurrence of a cognitive disorder after epilepsy surgery
Time frame: 12 months post-surgery compare to preoperative assessment (SEEG)
Relation between the presence in the epileptogenic zone of a gamma activation in at least 1 of the cognitive tasks performed during the ISD and the occurrence of a postoperative neuropsychological deficit (Wilcoxon test)
5 secondary outcomes
database on the dynamics of large cerebral networks underlying the main cognitive functions
Time frame: pre-surgical assessment (SEEG)
spatio-temporal organization of these networks with that predicted by fMRI
Time frame: preoperative assessment (SEEG, fMRI and cortical stimulations)
effect of intracerebral electrical stimulations
Time frame: preoperative assessment (SEEG, fMRI and cortical stimulations)
macro-electrophysiological recordings
Time frame: 12 months post-surgery compare to preoperative assessment (SEEG)
micro-electrophysiological recordings
Time frame: 12 months post-surgery compare to preoperative assessment (SEEG)
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 21 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 1
Study Designed to Evaluate the Safety, Tolerability, and PK of RAP-219 Formulated as an Long Acting Injectable.
Epilepsy
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.
Anne-Laure CHARLOIS contact
Sylvain RHEIMS, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Spectral Imaging (ISD) in people with Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Contact Sylvain RHEIMS, MD (472359343 ext. +33, sylvain.rheims@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictive character of the cortical gamma oscillatory pattern associated with a specific cognitive task on the risk of occurrence of a cognitive disorder after epilepsy surgery (time frame: 12 months post-surgery compare to preoperative assessment (SEEG)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.