RecruitingNot ApplicableNCT06852209

Training Cognition With Neurofeedback After Stroke

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


Sponsor

University Hospital, Bordeaux

Enrollment

20 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria11

  • Men or women
  • Right handed
  • ≤ 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 Criteria11

  • 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
  • st MRI incomplete, not performed or not analyzable

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Interventions

PROCEDURECognitive remediation therapy

Cognitive remediation therapy as treatment as usual

PROCEDURENeuropsychological assessment

Neuropsychological assessment to measure cognitive performances

PROCEDUREReal-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.

PROCEDUREfMRI sessions

fMRI sessions but without receiving feedback


Locations(1)

CHU de Bordeaux

Bordeaux, France

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NCT06852209


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