Study on Neurocognitive Plasticity in Patients With Focal... | NCT03543267

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

NCT03543267

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Jun 13, 2025Actual

Enrollment

37Actual

Phase

Not Applicable

Conditions

Epilepsy

Interventions

MRI exam

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 21, 2017Actual

Primary Completion Date

Jul 5, 2022Actual

Completion Date

Jul 5, 2022Actual

First Submitted Date

May 14, 2018

First Submission Date that Met QC Criteria

May 31, 2018

First Posted Date

Jun 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2025

Last Update Posted Date

Jun 13, 2025Actual

Name	Class
Laboratoire de Psychologie et NeuroCognition	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
epileptic Patients	Experimental		Other: MRI exam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI exam	Other	MRI before and after resection surgery	epileptic Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Monica BACIU, PhD	Centre National de la Recherche Scientifique, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Grenoble-Alpes		Grenoble		38043	France

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided