Training Cognition With Neurofeedback After Stroke

NCT ID: NCT06852209

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-11-28

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

Detailed Description

Stroke is a major source of cognitive impairment including slowdown of processing speed, executive functions disturbances, attention and memory loss, that can lead to invisible disability, even before the ultimate stage of dementia. The traditional techniques of cognitive remediation have been reported to have a small effect, and european scientific societies stated on the need to foster research in the field of PSCI, with the goal of preventing cognitive decline. PSCI mechanisms arising from functional MRI studies include a disconnexion of brain networks, with a loss of segregation between networks and integration within networks, centered on the frontoparietal network. Rt-fMRI NF is a psychophysiological procedure of brain-machine interface enabling to a subject to learn to self-regulate his brain activity in a desired direction, based on the brain haemodynamic response. Promising results in the treatment of mental disorders have been reported using rt-fMRI NF, but data are scarce in the field of cognitive rehabilitation after stroke. Based on the mechanisms of PSCI reported in fMRI studies, the goal of the present study is to evaluate the ability of stroke patients to learn to self-regulate a brain target using rt-fMRI NF. The brain target is defined by the difference of activation between the central executive network (CEN, or frontoparietal network) and the default mode network (DMN), known to be highly anticorrelated with the CEN in the healthy brain. The experimental procedure will include four training sessions of rt-fMRI NF (1/week), preceded by a localizer session for the identification of the target networks, and followed by a tranfer session where the subjects will be asked to try to self-regulate their brain activity but without receiving feedback. A control group will perform the four fMRI sessions but without receiving feedback. The two groups will receive cognitive remediation therapy as treatment as usual. Resting state scans and diffusion tensor imaging seqences will be performed before and after the intervention, to measure the changes in functional and structural connectivity. A neuropsychological assessment will be also performed before and after the intervention, to measure the changes in cognitive performances.

Conditions

Stroke; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Training sessions of rt-fMRI NF. The experimental procedure will include four training sessions of rt-fMRI NF (1/week), preceded by a localizer session for the identification of the target networks, and followed by a tranfer session where the subjects will be asked to try to self-regulate their brain activity but without receiving feedback

Group Type: EXPERIMENTAL

Cognitive remediation therapy

Intervention Type: PROCEDURE

Cognitive remediation therapy as treatment as usual

Neuropsychological assessment

Intervention Type: PROCEDURE

Neuropsychological assessment to measure cognitive performances

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

Intervention Type: PROCEDURE

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.

Control group

Four fMRI sessions but without receiving feedback

Group Type: ACTIVE_COMPARATOR

Cognitive remediation therapy

Intervention Type: PROCEDURE

Cognitive remediation therapy as treatment as usual

Neuropsychological assessment

Intervention Type: PROCEDURE

Neuropsychological assessment to measure cognitive performances

fMRI sessions

Intervention Type: PROCEDURE

fMRI sessions but without receiving feedback

Interventions

Cognitive remediation therapy

Cognitive remediation therapy as treatment as usual

Intervention Type: PROCEDURE

Neuropsychological assessment

Neuropsychological assessment to measure cognitive performances

Intervention Type: 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.

Intervention Type: PROCEDURE

fMRI sessions

fMRI sessions but without receiving feedback

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharmila SAGNIER

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Sharmila SAGNIER, Dr

Role: CONTACT

sharmila.sagnier@chu-bordeaux.fr

05 56 79 55 20

Facility Contacts

Sharmila SAGNIER, Dr

Role: primary

sharmila.sagnier@chu-bordeaux.fr

05 56 79 55 20

Other Identifiers

CHUBX 2023/43

Identifier Type: -

Identifier Source: org_study_id