Training cognitive skills using neurofeedback after a stroke

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

This study is testing whether stroke patients can improve their thinking skills by using brain training with real-time feedback from brain scans.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University Hospital, Bordeaux (other)
• Locations: 1 site (Bordeaux)
• Trial ID: NCT06852209 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the ability of stroke patients to learn self-regulation of their brain activity through real-time functional MRI neurofeedback (rt-fMRI NF). It focuses on patients who have experienced a first-ever ischemic stroke and are suffering from cognitive impairments. The intervention involves cognitive remediation therapy and neuropsychological assessments, alongside fMRI sessions to monitor brain activity. The goal is to enhance cognitive functions by targeting specific brain networks associated with cognitive decline post-stroke.

Who should consider this trial

Good fit: Ideal candidates are right-handed adults aged 18 to 75 who have had a first-ever ischemic stroke within the last 3 to 6 months and exhibit cognitive complaints.

Not a fit: Patients with severe visual disabilities, aphasia, or significant pre-stroke disabilities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve cognitive function and quality of life for stroke survivors experiencing cognitive impairments.

How similar studies have performed: While promising results have been reported in the treatment of mental disorders using rt-fMRI NF, data on its effectiveness for cognitive rehabilitation after stroke is limited, making this approach relatively novel.

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

Where this trial is running

Bordeaux

• CHU de Bordeaux — Bordeaux, France (RECRUITING)

Study contacts

• Principal investigator: Sharmila SAGNIER — University Hospital, Bordeaux
• Study coordinator: Sharmila SAGNIER, Dr

Conditions: Stroke, Cognitive Impairment, Cognition, Real time-fMRI, Neurofeedback