Informations générales (source: ClinicalTrials.gov)
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) (ISD SEEG)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
juin 2017
janvier 2030
05 avril 2025
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Hospices Civils de Lyon - 69500 - Bron - France | Sylvain RHEIMS, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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