NCT06852209Recruiting
Training Cognition With Neurofeedback After Stroke
Cognitive Impairment Mechanisms and Training With Real Time-functional MRI Neurofeedback After Stroke
Source: ClinicalTrials.gov · Last updated 2 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Post-stroke cognitive impairment (PSCI) is a common source of invisible disability. The actual techniques of cognitive remediation have been reported to have only a small effect, justifying the need to foster research in this field. Real-time functional MRI neurofeedack (rt-fMRI NF) is a procedure of brain-machine interface supporting self-regulation of brain activity, with promising results in the treatment of mental disorders. The main objective of the study is to evaluate in a pilot study, the ability of stroke patients to learn to self-regulate their brain activity in a priviledged direction, using rt-fMRI NF
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 2 Dec 2024
- Start date
- 28 Feb 2025
- Primary completion date
- 28 Oct 2026
- Lead sponsor
- University Hospital, Bordeaux
- Diseases
- Stroke
- NCT number
- NCT06852209
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 28 Feb 2025 to the primary completion date, 28 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous cognitive impairment ;
- Current use of psychotropic medication ;
Other illness
- History of psychiatric disorder ;
- Chronic disease empeding the follow-up of the subject during the lenght of the study ;
Other
- MRI contraindication ;
- Pregnancy or breastfeeding ;
- Non fluently-French speakers ;
- Patient under legal protection.
- Patient unable of giving personal consent
- Emergency situation
- 1st MRI incomplete, not performed or not analyzable
Who the study is looking for
- Men or women
- Right handed
- 18 ≤ years old \< 75
- first-ever ischemic stroke on brain MRI in the past 3 to 6 months ;
- Persisting cognitive complaint 3 months after the ischemic stroke, proved by a MoCA score ≤ 26 (if educational level ≥ 12 years, or ≤ 25 if educational level \< 12 years), and involving at least one of the following cognitive domains : executive functions, attention, and processing speed ;
- Ischemic stroke located in the territory of the middle cerebral artery and /or basal ganglia/thalamus ;
- NIHSS ≤ 5, without aphasia or severe visual disability empeding the understanding of the instructions, the neurofeedback task achievement, and/or the neuropsychological assessment ;
- No prestroke disability defined by a modified Rankin Scale ≤ 2 ;
- For women of childbearing potential, use of effective contraception and negative pregnancy test.
- Written informed consent by the patient.
- Coverage by the French Social Insurance
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.