Training Cognition With Neurofeedback After Stroke

NCT06852209 | Recruiting

• 1 other identifier: CHUBX 2023/43
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Cognitive Impairment

Keywords

Stroke; Cognition; Real time-fMRI; Neurofeedback

Outcome Measures

Primary Outcomes (1)

• Differential CEN-DMN activity and imaging contrast between regulation and rest

  Change from baseline to each training session on the CEN-DMN activity during regulation compared with rest, in the experimental and control groups

  Through study training completion, an average of 4 weeks

Secondary Outcomes (16)

• Evolution of global cognition assessed by the Montreal Cognitive Assessment (MoCA)

  Through study completion, an average of 6 weeks

• Evolution of executive functions assessed by a composite score

  through study completion, an average of 6 weeks

• Evolution of attentional functions assessed by the Mesulam cancellation task

  Through study completion, an average of 6weeks

• Evolution of processing speed assessed by the Symbol Digit Modalities Test (SDMT)

  Through study completion, an average of 6 weeks

• Evolution of memory functions assessed by the 16-item Free and Cued Recall

  Through study completion, an average of 6 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Procedure: Cognitive remediation therapy; Procedure: Neuropsychological assessment; Procedure: Real-time functional MRI neurofeedack (rt-fMRI NF)

Control group

ACTIVE COMPARATOR

Four fMRI sessions but without receiving feedback

Procedure: Cognitive remediation therapy; Procedure: Neuropsychological assessment; Procedure: fMRI sessions

Interventions

Cognitive remediation therapy PROCEDURE

Cognitive remediation therapy as treatment as usual

Control group; Experimental group

Neuropsychological assessment PROCEDURE

Neuropsychological assessment to measure cognitive performances

Control group; Experimental group

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

Experimental group

fMRI sessions PROCEDURE

fMRI sessions but without receiving feedback

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Stroke; Cognitive Dysfunction

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Sharmila SAGNIER

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharmila SAGNIER, Dr

CONTACT

05 56 79 55 20; sharmila.sagnier@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: February 28, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): November 28, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

FR (1)