Training Cognition With Neurofeedback After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive remediation therapy, Neuropsychological assessment, Real-time functional MRI neurofeedack (rt-fMRI NF), fMRI sessions.
- Who it may be relevant to
- Registry conditions: Stroke, Cognitive Impairment. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cognitive Impairment Mechanisms and Training With Real Time-functional MRI Neurofeedback After Stroke
Overview
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.
Interventions
- Procedure Cognitive remediation therapy
Cognitive remediation therapy as treatment as usual - Procedure Neuropsychological assessment
Neuropsychological assessment to measure cognitive performances - 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. - Procedure fMRI sessions
fMRI sessions but without receiving feedback
Primary outcome measures
- Differential CEN-DMN activity and imaging contrast between regulation and rest [Time frame: Through study training completion, an average of 4 weeks]
Secondary outcome measures (12)
- Evolution of global cognition assessed by the Montreal Cognitive Assessment (MoCA) [Time frame: Through study completion, an average of 6 weeks]
- Evolution of executive functions assessed by a composite score [Time frame: through study completion, an average of 6 weeks]
- Evolution of attentional functions assessed by the Mesulam cancellation task [Time frame: Through study completion, an average of 6weeks]
- Evolution of processing speed assessed by the Symbol Digit Modalities Test (SDMT) [Time frame: Through study completion, an average of 6 weeks]
- Evolution of memory functions assessed by the 16-item Free and Cued Recall [Time frame: Through study completion, an average of 6 weeks]
- Evolution of visuospatial functions assessed by the Rey figure [Time frame: Through study completion, an average of 6 weeks]
- Evolution of language functions assessed byt the 40-item neuropsychological semantic battery [Time frame: Through study completion, an average of 6 weeks]
- Evolution of the Central Executive Network (CEN) activity [Time frame: Through study training completion, an average of 4 weeks]
- Evolution of the Default Mode Network (DMN) activity [Time frame: Through study training completion, an average of 4 weeks]
- Evolution of activity in the whole brain [Time frame: Through study training completion, an average of 4 weeks]
- Evolution of resting state CEN and DMN activity [Time frame: Through study completion, an average of 6 weeks]
- Microstructural changes assessed by Fractional Anisotropy (FA) [Time frame: Through study completion, an average of 6 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
France · 1 center
- CHU de Bordeaux — Bordeaux
Identifiers
NCT: NCT06852209 · CHUBX 2023/43