StrokeCITRINeSNCT06852209
Training Cognition With Neurofeedback After Stroke
A study testing Cognitive remediation therapy, Neuropsychological assessment and Real-time functional MRI neurofeedack (rt-fMRI NF) in people with Stroke and Cognitive Impairment, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Cognitive Impairment
- What is being tested?
- Cognitive remediation therapy, Neuropsychological assessment and Real-time functional MRI neurofeedack (rt-fMRI NF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2025to 28 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ;
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- 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
Who cannot join
- 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 ;
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- Non fluently-French speakers ;
- Patient under legal protection.
- Patient unable of giving personal consent
- Emergency situation
- 1st MRI incomplete, not performed or not analyzable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux
Sharmila SAGNIER, Dr, 05 56 79 55 20, sharmila.sagnier@chu-bordeaux.fr
About this study
Official title: Cognitive Impairment Mechanisms and Training With Real Time-functional MRI Neurofeedback After Stroke
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
Read the 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
- Being tested
- Cognitive remediation therapy, Neuropsychological assessment, Real-time functional MRI neurofeedack (rt-fMRI NF), fMRI sessions
- Keywords
- Stroke, Cognition, Real time-fMRI, Neurofeedback
- Medical subject headings
- Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive remediation therapyProcedure or surgery
Cognitive remediation therapy as treatment as usual
Neuropsychological assessmentProcedure or surgery
Neuropsychological assessment to measure cognitive performances
Real-time functional MRI neurofeedack (rt-fMRI NF)Procedure or surgery
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.
fMRI sessionsProcedure or surgery
fMRI sessions but without receiving feedback
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Cognitive remediation therapy; Procedure: Neuropsychological assessment; Procedure: fMRI sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study training completion, an average of 4 weeks
Secondary outcomes (16)
Evolution of global cognition assessed by the Montreal Cognitive Assessment (MoCA)
Change from baseline to the end of the study on the MoCA score. The MoCA score allows the detection of mild cognitive impairment and is ranged from 0 (minimum) to 30 (maximum : no cognitive impairment).
Measured: Through study completion, an average of 6 weeks
Evolution of executive functions assessed by a composite score
Change from baseline to the end of the study on a composite Z-score made from the averages of the Z-scores of the following tests :
- verbal fluency : the subject is asked to cite a maximum of animals, letters starting with the letter P and V in 60 seconds) ;
- memory span (working memory) : the subject is asked to restitute a maximum of the items of a list immediatly after hearing them) ;
- Trail making Test (cognitive flexibility) : the subject is asked to link a set of digits in increasing order, alternating with letters, or items of different shapes or colors, the number of errors is recorded ;
- Stroop task (inhibition capacity) : the subject is asked to name the font color of a list of words of colors which don't match their font color ;
- Zoo testing plan (scheduling ability) : the subject is asked to follow a list of instructions for the visit of a zoo, while dealing with a list of constraints.
Measured: through study completion, an average of 6 weeks
Evolution of attentional functions assessed by the Mesulam cancellation task
Change from baseline to the end of the study on the Mesulam cancellation task : the subject is asked to cancel a specific target among random arrays of structured and unstructured verbal and nonverbal stimuli.
Measured: Through study completion, an average of 6weeks
Evolution of processing speed assessed by the Symbol Digit Modalities Test (SDMT)
Change from baseline to the end of the study on the SDMT : the subject is provided with a set of symbols corresponding to numbers, and he is asked to write the symbols corresponding to a specific list of numbers in 5 minutes.
Measured: Through study completion, an average of 6 weeks
Evolution of memory functions assessed by the 16-item Free and Cued Recall
Change from baseline to the end of the study on the 16-item Free and Cued Recall : the subject is asked to recall a set of 16 words presented by 4, immediately and after an interfering task, the number of free and cued correct recalls are recorded.
Measured: Through study completion, an average of 6 weeks
Evolution of visuospatial functions assessed by the Rey figure
Change from baseline to the end of the study on the Rey figure : the subject is asked to copy a complex figure as quickly as possible, and then, to reproduce the figure without the model.
Measured: Through study completion, an average of 6 weeks
Evolution of language functions assessed byt the 40-item neuropsychological semantic battery
Change from baseline to the end of the study on the 40-item neuropsychological semantic battery : the subject is asked to name a set of 40 living and non living items in verbal and visual conditions, across 6 subtests of matching.
Measured: Through study completion, an average of 6 weeks
Evolution of the Central Executive Network (CEN) activity
Change from baseline to each training session in the CEN activity recorded in the CEN mask during regulation compared with rest, in the experimental and control groups. The CEN mask is a binary mask individualized after running a pipeline for each subject, and the functional activity into this mask is extracted to assess the specific trajectory of the CEN activity.
Measured: Through study training completion, an average of 4 weeks
Evolution of the Default Mode Network (DMN) activity
Change from baseline to each training session in the DMN activity recorded in the DMN mask during regulation compared with rest, in the experimental and control groups. The DMN mask is a binary mask individualized after running a pipeline for each subject, and the functional activity into this mask is extracted to assess the specific trajectory of DMN activity.
Measured: Through study training completion, an average of 4 weeks
Evolution of activity in the whole brain
Change from baseline to each training session on the whole brain activity during regulation compared with rest, in the experimental and control groups
Measured: Through study training completion, an average of 4 weeks
Evolution of resting state CEN and DMN activity
Change in correlation between resting state CEN and DMN activity before intervention compared with after intervention.
Measured: Through study completion, an average of 6 weeks
Microstructural changes assessed by Fractional Anisotropy (FA)
Change in median FA parameters before intervention compared with after intervention
Measured: Through study completion, an average of 6 weeks
Microstructural changes assessed by Mean Diffusivity (MD)
Change in median MD parameters (mm2/sec) before intervention compared with after intervention
Measured: Through study completion, an average of 6 weeks
Microstructural changes assessed by Axial Diffusivity (AD)
Change in median AD parameters (mm2/sec) before intervention compared with after intervention
Measured: Through study completion, an average of 6 weeks
Microstructural changes assessed by Radial Diffusivity (RD)
Change in median RD parameters (mm2/sec) before intervention compared with after intervention
Measured: Through study completion, an average of 6 weeks
Differential CEN-DMN activity and imaging contrast between regulation and rest, without neurofeedback
Change from baseline to the last fMRI session (" transfert session " without neurofeedback) on the CEN-DMN activity during regulation compared with rest, in the experimental and control groups
Measured: Through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start28 Feb 2025
- Primary completion28 Oct 2026 (estimated)
- Study completion28 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharmila SAGNIER, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852209
- Sponsor's protocol ID
- CHUBX 2023/43
- Acronym
- CITRINeS
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment Mechanisms and Training With Real Time-functional MRI Neurofeedback After Stroke
- ClinicalTrials.gov ID
- NCT06852209
- Acronym / sponsor ID
- CITRINeS / CHUBX 2023/43
- Conditions
- Stroke, Cognitive Impairment
- Keywords
- Stroke, Cognition, Real time-fMRI, Neurofeedback
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 28 Oct 2026 (estimated)
- Study completion
- 28 Nov 2026 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Cognitive remediation therapy, Procedure: Neuropsychological assessment, Procedure: Real-time functional MRI neurofeedack (rt-fMRI NF)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 |
| Control group | Active comparator | Procedure: Cognitive remediation therapy, Procedure: Neuropsychological assessment, Procedure: fMRI sessionsFour fMRI sessions but without receiving feedback |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 ;
Key exclusion criteria (11 listed)
- Previous cognitive impairment ;
- History of psychiatric disorder ;
- Current use of psychotropic medication ;
- MRI contraindication ;
- Pregnancy or breastfeeding ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive remediation therapyCognitive remediation therapy as treatment as usual | Procedure or surgery | Control group, Experimental group |
| Neuropsychological assessmentNeuropsychological assessment to measure cognitive performances | Procedure or surgery | Control group, Experimental group |
| 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 or surgery | Experimental group |
| fMRI sessionsfMRI sessions but without receiving feedback | Procedure or surgery | Control group |
Primary outcome
Differential CEN-DMN activity and imaging contrast between regulation and rest
Time frame: Through study training completion, an average of 4 weeks
Change from baseline to each training session on the CEN-DMN activity during regulation compared with rest, in the experimental and control groups
16 secondary outcomes
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
Microstructural changes assessed by Mean Diffusivity (MD)
Time frame: Through study completion, an average of 6 weeks
Microstructural changes assessed by Axial Diffusivity (AD)
Time frame: Through study completion, an average of 6 weeks
Microstructural changes assessed by Radial Diffusivity (RD)
Time frame: Through study completion, an average of 6 weeks
Differential CEN-DMN activity and imaging contrast between regulation and rest, without neurofeedback
Time frame: Through study completion, an average of 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sharmila SAGNIER principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive remediation therapy, Neuropsychological assessment and Real-time functional MRI neurofeedack (rt-fMRI NF) in people with Stroke and Cognitive Impairment, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharmila SAGNIER, Dr (05 56 79 55 20, sharmila.sagnier@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential CEN-DMN activity and imaging contrast between regulation and rest (time frame: Through study training completion, an average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.