Understanding brain changes in patients with drug-resistant epilepsy
Feasibility Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy, Before and After Surgery. Evaluation by Functional and Anatomic Neuroimaging
This study is testing how surgery affects brain changes in people with drug-resistant epilepsy to see if it helps improve their cognitive functions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT03543267 on ClinicalTrials.gov |
What this trial studies
This study aims to define the neurocognitive plasticity profiles in patients with focal and drug-resistant epilepsy before and after surgical intervention. Participants will undergo two MRI examinations: one prior to surgery and another between 3 to 8 months post-surgery to assess changes in brain function and structure. The focus is on understanding how the brain reorganizes itself in response to the epileptogenic zone. This research could provide insights into cognitive functions affected by epilepsy and the impact of surgical treatment.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with pharmaco-resistant focal epilepsy who are candidates for surgery to remove the epileptogenic zone.
Not a fit: Patients with contraindications for MRI or severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of brain plasticity in epilepsy, potentially leading to improved surgical outcomes and cognitive rehabilitation strategies.
How similar studies have performed: While studies on neuroplasticity in epilepsy exist, this specific approach focusing on pre- and post-surgical MRI assessments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with diagnosis of pharmaco-resistant focal epilepsy * Patient candidate for surgery to resect the epileptogenic zone * Patients affiliated to a social security scheme or beneficiaries of such a scheme * Patients with French as their mother tongue * Patients who have given signed informed consent before performing any procedure related to the study. Exclusion Criteria: * Contraindication to performing an MRI: * Intellectual disability objectified by a Mini Mental Score (MMS) score \<24 in the year preceding inclusion, * Existence of a severe condition in general: cardiac, respiratory, hematological, renal, hepatic, cancerous, * Participation in other research protocols underway with exclusion period or in the previous week, * Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code.
Where this trial is running
Grenoble
- CHU Grenoble-Alpes — Grenoble, France (Recruiting)
Study contacts
- Principal investigator: Monica BACIU, PhD — Centre National de la Recherche Scientifique, France
- Study coordinator: Emilie Cousin, PhD
- Email: emilie.cousin@univ-grenoble-alpes.fr
- Phone: 00334.76.82.58.91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.