TerminatedNot Applicable

Modulation and Assessment of Mental Flexibility in Dysexecutive Brain Patients

Stopped: terminated with16 included patients instead of 18

France16 participantsStarted 2020-02-04

Plain-language summary

This project aims to (1) define and characterize brain networks of cognitive flexibility amongst patients with frontal lesions; (2) quantify the effects of ecological cognitive trainings and brain stimulation on behavioral performance and brain networks; (3) identify predictive markers of effective rehabilitation (patients)

Who can participate

Age range

20 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Affiliated to social security * Signed informed consent * Mother tongue: French * Right handed (Edimburg Scale) * Frontal traumatic brain injury or stroke responsible for a dysexecutive syndrome assessed by the GREFEX battery. Exclusion Criteria: * Claustrophobia * Addiction * Major Hearing or Visual loss * Hearing prosthesis * Metal intraocular implant * Cardiac prosthesis * High Blood pressure * Severe cardiac insufficiency * Uncompensated thyroid disorders * Major neuropsychological disorder * Family or personal history of epilepsy * Pregnancy * Female subject of childbearing age not receiving effective contraception. * Participation in another experimental protocol involving brain stimulation within the last 4 weeks * Person under the protection of justice, tutorship or curatorship * MRI contraindication * Refusal to be informed of a new anomaly detected during the MRI examination * Other traumatic brain injury or neuropsychological disorder

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evolution of performance at GAS (Goal Attainment scaling) in long term

Timeframe: The month following the cognitive training phase (TF+1)

Trial details

NCT IDNCT04253522

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-13

View on ClinicalTrials.gov More Dysexecutive Syndrome trials