NCT06852209 Training Cognition With Neurofeedback After Stroke
| NCT ID | NCT06852209 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-28 |
| Primary Completion | 2026-10-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-02-28 with a primary completion date of 2026-10-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Previous cognitive impairment ; * History of psychiatric disorder ; * Current use of psychotropic medication ; * MRI contraindication ; * Pregnancy or breastfeeding ; * Chronic disease empeding the follow-up of the subject during the lenght of the study ; * Non fluently-French speakers ; * Patient under legal protection. * Patient unable of giving personal consent * Emergency situation * 1st MRI incomplete, not performed or not analyzable
Contact & Investigator
Sharmila SAGNIER
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT06852209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06852209 currently recruiting?
Yes, NCT06852209 is actively recruiting participants. Contact the research team at sharmila.sagnier@chu-bordeaux.fr for enrollment information.
Where is the NCT06852209 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT06852209 clinical trial?
NCT06852209 is sponsored by University Hospital, Bordeaux. The principal investigator is Sharmila SAGNIER at University Hospital, Bordeaux. The trial plans to enroll 20 participants.
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