Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy

Epilepsy Clinical Trial

— FaisPLASTICITE  

Official title:

Feasibility Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy, Before and After Surgery. Evaluation by Functional and Anatomic Neuroimaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03543267
• Other study ID #: 38RC17.018
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2017
• Est. completion date: December 21, 2024

Study information

• Verified date: August 2023
• Source: University Hospital, Grenoble
• Contact: Emilie Cousin, PhD
• Phone: 00334.76.82.58.91
• Email: emilie.cousin[@]univ-grenoble-alpes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study consist of define anatomo-functional reorganization (plasticity) profiles for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.

For that, patients will have 2 MRI examinations, one before surgery and the second, between 3 and 8 months after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 21, 2024
• Est. primary completion date: December 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

Other:
• MRI exam
MRI before and after resection surgery

Locations

Country	Name	City	State
France	CHU Grenoble-Alpes	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Laboratoire de Psychologie et NeuroCognition

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to define anatomo-functional reorganization (plasticity) profiles by functional MRI for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.	The outcome measure is the hemispheric lateralization index (IL) before surgery measured by functional MRI	One hour and thirty minutes