NCT03102957

Brief Summary

Exploring the reorganization (plasticity) of neuroanatomic networks associated with language and memory in patients with left (or dominant hemisphere) temporal lobe epilepsy using functional MRI (fMRI)

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2009

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
Last Updated

April 6, 2017

Status Verified

March 1, 2017

Enrollment Period

7.2 years

First QC Date

March 22, 2017

Last Update Submit

April 5, 2017

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • neuronal reorganization exploration in language and memory area thanks to functionnal MRI

    fMRI exam before and after resection surgery of epileptogenic area: assess (plasticity) of neuroanatomic networks associated with language and memory - examined before and after surgery

    one hour for each exam

Study Arms (2)

epileptic patients

EXPERIMENTAL

2 functional MRI (pre and post resective surgery) with memory and language tasks

Other: functional MRI

Healthy volunteers

OTHER

1 functional MRI with memory and language tasks

Other: functional MRI

Interventions

functional MRIOTHER
Healthy volunteersepileptic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • epileptic patients
  • social security affiliation
  • Pharmaco-resistant epilepsy

You may not qualify if:

  • MRI contraindication
  • pregnant women
  • breastfeeding mothers
  • person under tutorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Alexandre KRAINIK, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 2 arms : epileptic patient and healthy volonteers
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2017

First Posted

April 6, 2017

Study Start

June 17, 2009

Primary Completion

August 31, 2016

Study Completion

August 31, 2016

Last Updated

April 6, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share