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RECRUITINGINTERVENTIONAL

Training Cognition With Neurofeedback After Stroke

Cognitive Impairment Mechanisms and Training With Real Time-functional MRI Neurofeedback After Stroke

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form by the patient. - Coverage by the French Social Insurance Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Cognitive remediation therapy

Cognitive remediation therapy as treatment as usual

PROCEDURE

Neuropsychological assessment

Neuropsychological assessment to measure cognitive performances

PROCEDURE

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.

PROCEDURE

fMRI sessions

fMRI sessions but without receiving feedback

Locations (1)

CHU de Bordeaux
Bordeaux, France