Training Cognition With Neurofeedback After Stroke (CITRINeS)

March 27, 2025 updated by: University Hospital, Bordeaux

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Active Comparator: Control group
Four fMRI sessions but without receiving feedback
Procedure: Cognitive remediation therapy
Cognitive remediation therapy as treatment as usual
Procedure: Neuropsychological assessment
Neuropsychological assessment to measure cognitive performances
Procedure: fMRI sessions
fMRI sessions but without receiving feedback

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Through study training completion, an average of 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evolution of global cognition assessed by the Montreal Cognitive Assessment (MoCA)
Time Frame: Through study completion, an average of 6 weeks
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).
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

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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
Change from baseline to each training session on the whole brain activity during regulation compared with rest, in the experimental and control groups
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
Change in correlation between resting state CEN and DMN activity before intervention compared with after intervention.
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
Change in median FA parameters before intervention compared with after intervention
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
Change in median MD parameters (mm2/sec) before intervention compared with after intervention
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
Change in median AD parameters (mm2/sec) before intervention compared with after intervention
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
Change in median RD parameters (mm2/sec) before intervention compared with after intervention
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
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
Through study completion, an average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sharmila SAGNIER, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2023/43

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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