EpilepsyFaisPLASTICITENCT03543267
Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy
A study testing MRI exam in people with Epilepsy, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- MRI exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 21 Oct 2017to 5 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Epilepsy
- Being tested
- MRI exam
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI examOther
MRI before and after resection surgery
| Study group | Role | What they receive |
|---|---|---|
| epileptic Patients | Experimental | Not described Receives: Other: MRI exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One hour and thirty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start21 Oct 2017
- Primary completion5 Jul 2022
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition
- Responsible party
- Sponsor
- Investigators
- Monica BACIU, PhD, Principal investigator, Centre National de la Recherche Scientifique, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543267
- Sponsor's protocol ID
- 38RC17.018
- Acronym
- FaisPLASTICITE
- Status last verified
- Jun 2025
- First submitted
- 14 May 2018
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03543267
- Acronym / sponsor ID
- FaisPLASTICITE / 38RC17.018
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition
- Study start
- 21 Oct 2017 (actual)
- Primary completion
- 5 Jul 2022 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epileptic Patients | Experimental | Other: MRI exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI examMRI before and after resection surgery | Other | epileptic Patients |
Primary outcome
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.
Time frame: One hour and thirty minutes
The outcome measure is the hemispheric lateralization index (IL) before surgery measured by functional MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica BACIU, PhD principal investigator
Centre National de la Recherche Scientifique, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI exam in people with Epilepsy, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: One hour and thirty minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.