Ireland
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Recruiting Not applicable

Training Cognition With Neurofeedback After Stroke

NCT06852209 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-02-28
Last updated
2025-04-02

Condition(s) studied

StrokeCognitive Impairment

Investigational drug(s) / intervention(s)

Cognitive remediation therapyNeuropsychological assessmentReal-time functional MRI neurofeedack (rt-fMRI NF)fMRI sessions

Cognitive remediation therapy: Cognitive remediation therapy as treatment as usual

Neuropsychological assessment: Neuropsychological assessment to measure cognitive performances

Real-time functional MRI neurofeedack (rt-fMRI NF): 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.

fMRI sessions: fMRI sessions but without receiving feedback

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Differential CEN-DMN activity and imaging contrast between regulation and rest — Through study training completion, an average of 4 weeks
    Change from baseline to each training session on the CEN-DMN activity during regulation compared with rest, in the experimental and control groups

Trial sites (1)

FacilityCityRegionStatus
CHU de Bordeaux Bordeaux France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06852209 on ClinicalTrials.gov ↗ ← All trials in France