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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Bordeaux
RECRUITING
Bordeaux
Contact Information
Primary
Sharmila SAGNIER, Dr
sharmila.sagnier@chu-bordeaux.fr
05 56 79 55 20
Time Frame
Start Date: 2025-02-28
Estimated Completion Date: 2026-11-28
Participants
Target number of participants: 20
Treatments
Experimental: 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
Active_comparator: Control group
Four fMRI sessions but without receiving feedback
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Bordeaux

This content was sourced from clinicaltrials.gov