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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Hospices Civils de Lyon

    Bron, 69500

    Sylvain RHEIMS, MD, 472359343 ext. +33, sylvain.rheims@chu-lyon.fr

    Anne-Laure CHARLOIS

    Recruiting

Other trials in France

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 groups in NCT03094312
Study groupRoleWhat they receive
Dynamic Spectral Imaging (ISD)ExperimentalEvaluation 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.

  1. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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.

  1. First posted29 Mar 2017
  2. Study start23 Jun 2017
  3. Primary completion23 Jan 2030 (estimated)
  4. Study completion23 Jan 2030 (estimated)

Resources

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)
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

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.

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