StrokefNIRS-NFBNCT07876700
Enabling Bedside Brain Measurement of Motor Outcomes Post Stroke
A study testing fNIRS-neurofeedback in people with Stroke, run by Sue Peters.
Trial summary
The goal of this basic neuroscience study is to learn whether visual feedback of brain activity can help improve arm and hand recovery in people who recently had a stroke. The study will also examine whether this type of training is practical to use during early stroke rehabilitation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- fNIRS-neurofeedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Oct 2029
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke patients in the subacute phase
- upper extremity hemiparesis (< or =4/5 manual muscle grade in at least one of the major upper extremity muscles)
- Modified Rankin Scale (mRS) score of <2 pre-stroke
- Able to communicate in English
- Able to comprehend instructions and provide informed consent
Who cannot join
- cognitive deficits
- have another known neurological or serious medical condition (e.g., Parkinson's, active cancer, etc.)
- Present with severe receptive aphasia which would compromise their ability to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Enabling Bedside Brain Measurement to Maximize Motor Outcomes After Stroke
The goal of this basic neuroscience study is to learn whether visual feedback of brain activity can help improve arm and hand recovery in people who recently had a stroke. The study will also examine whether this type of training is practical to use during early stroke rehabilitation. Researchers will compare two groups of participants. Both groups will practice reaching for and grasping a cup, either by physically performing the movement or imagining the movement. One group will receive visual feedback showing their brain activity during practice. The other group will complete the same practice without seeing this feedback. Participants will be randomly assigned to one of these groups.
The study will include 60 participants who had a stroke and who have weakness in one arm. Participants will complete 8 in-person sessions over 2 weeks. The first and last sessions will include tests of arm function, disability, quality of life, and brain activity. The 6 sessions in between will involve repeated movement or imagined movement practice. During the sessions, researchers will use functional near-infrared spectroscopy (fNIRS), a non-invasive brain imaging tool that shines light into the scalp to measure changes in brain activity. Small sensors placed on the skin of the arm and hand will also be used to measure muscle activity.
Read the detailed description
This is a two-site mechanistic study involving 60 participants with stroke. Participants will be in the subacute stage of recovery after a stroke with weakness in the arm. This study will examine whether functional near-infrared spectroscopy (fNIRS)-based neurofeedback can be used during upper-limb rehabilitation in people recovering from a recent stroke. Participants will be randomized to one of two groups and in both groups will complete the same repetitive upper-limb practice while wearing the fNIRS cap. The main difference between the groups is that participants in the neurofeedback group will receive individualized visual feedback based on their brain activity, while participants in the control group will not receive this visual feedback. fNIRS data will be recorded in both groups.
Each participant will complete 8 sessions. Session 1 will consist of a pre-intervention assessment, sessions 2 through 7 will consist of intervention sessions, and session 8 will consist of a post-intervention assessment. The intervention will include either a motor task or imagery task. For the active motor task, participants will repeatedly attempt to reach for and grasp a cup until instructed to rest. For the mental imagery task, participants will repeatedly imagine reaching for and grasping a cup without physically performing the movement. Electromyography (EMG) electrodes will also be placed on the skin over the muscles of the weaker arm to record muscle activity. During practice, participants assigned to the neurofeedback group will receive visual feedback representing changes in their brain activity. Participants in the control group will perform the same task-based practice and undergo the same fNIRS recordings but will not see visual feedback about their brain activity.
Clinical assessments will also be collected to characterize stroke severity, upper-limb impairment, arm activity, quality of life, and overall disability. Study feasibility will be evaluated in part by recording attendance and comparing the number of completed intervention sessions with the number of scheduled sessions.
- Conditions
- Stroke
- Being tested
- fNIRS-neurofeedback, Control
- Keywords
- rehabilitation, exercise, arm, upper limb
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fNIRS-neurofeedbackOther
This group receives visual feedback of the fNIRS signal
ControlOther
Control group
| Study group | Role | What they receive |
|---|---|---|
| neurofeedback group | Experimental | This group will receive visual feedback of the fNIRS signal Receives: Other: fNIRS-neurofeedback |
| Control group | Active comparator | This group will not receive visual feedback Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional Near Infrared Spectroscopy (fNIRS) amplitude over the motor cortex
brain activity
Measured: Session 8 (up to 6 months post stroke)
Secondary outcomes (8)
National Institutes of Health Stroke Scale
stroke severity (0=no deficit, 42=maximum deficit)
Measured: Pre-intervention
Fugl-Meyer Upper Extremity
motor impairment, (0=maximum impairment, 66=no impairment)
Measured: Session 8 (up to 6 months post stroke)
Action Research Arm Test
motor activity (0=maximum impairment, 57=no impairment)
Measured: Session 8 (up to 6 months post stroke)
EuroQol Five Dimensions
quality of life (5=best quality of life, 25=lowest quality of life)
Measured: Session 8 (up to 6 months post stroke)
Modified Rankin Scale
disability (1=no disability, 6=dead)
Measured: Session 8 (up to 6 months post stroke)
fNIRS amplitude of other motor and prefrontal areas
mechanistic measure
Measured: Session 8 (up to 6 months post stroke)
Electromyography (EMG) over the wrist, elbow, and shoulder muscles
muscle activity
Measured: Session 8 (up to 6 months post stroke)
Number of attended sessions
feasibility
Measured: Sessions 1 through to Session 8 (from enrolment up to 6 months post stroke)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Oct 2029 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sue Peters
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Responsible party
- Sponsor-investigator, Sue Peters, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876700
- Sponsor's protocol ID
- Project ID 129592
- Acronym
- fNIRS-NFB
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At minimum, summary statistics will be provided in the primary outcomes paper.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enabling Bedside Brain Measurement to Maximize Motor Outcomes After Stroke
- ClinicalTrials.gov ID
- NCT07876700
- Acronym / sponsor ID
- fNIRS-NFB / Project ID 129592
- Conditions
- Stroke
- Keywords
- rehabilitation, exercise, arm, upper limb
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sue PetersUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 15 Oct 2026 (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.
The goal of this basic neuroscience study is to learn whether visual feedback of brain activity can help improve arm and hand recovery in people who recently had a stroke. The study will also examine whether this type of training is practical to use during early stroke rehabilitation. Researchers will compare two groups of participants. Both groups will practice reaching for and grasping a cup, either by physically performing the movement or imagining the movement. One group will receive visual feedback showing their brain activity during practice. The other group will complete the same practice without seeing this feedback. Participants will be randomly assigned to one of these groups.
The study will include 60 participants who had a stroke and who have weakness in one arm. Participants will complete 8 in-person sessions over 2 weeks. The first and last sessions will include tests of arm function, disability, quality of life, and brain activity. The 6 sessions in between will involve repeated movement or imagined movement practice. During the sessions, researchers will use functional near-infrared spectroscopy (fNIRS), a non-invasive brain imaging tool that shines light into the scalp to measure changes in brain activity. Small sensors placed on the skin of the arm and hand will also be used to measure muscle activity.
Detailed description
This is a two-site mechanistic study involving 60 participants with stroke. Participants will be in the subacute stage of recovery after a stroke with weakness in the arm. This study will examine whether functional near-infrared spectroscopy (fNIRS)-based neurofeedback can be used during upper-limb rehabilitation in people recovering from a recent stroke. Participants will be randomized to one of two groups and in both groups will complete the same repetitive upper-limb practice while wearing the fNIRS cap. The main difference between the groups is that participants in the neurofeedback group will receive individualized visual feedback based on their brain activity, while participants in the control group will not receive this visual feedback. fNIRS data will be recorded in both groups.
Each participant will complete 8 sessions. Session 1 will consist of a pre-intervention assessment, sessions 2 through 7 will consist of intervention sessions, and session 8 will consist of a post-intervention assessment. The intervention will include either a motor task or imagery task. For the active motor task, participants will repeatedly attempt to reach for and grasp a cup until instructed to rest. For the mental imagery task, participants will repeatedly imagine reaching for and grasping a cup without physically performing the movement. Electromyography (EMG) electrodes will also be placed on the skin over the muscles of the weaker arm to record muscle activity. During practice, participants assigned to the neurofeedback group will receive visual feedback representing changes in their brain activity. Participants in the control group will perform the same task-based practice and undergo the same fNIRS recordings but will not see visual feedback about their brain activity.
Clinical assessments will also be collected to characterize stroke severity, upper-limb impairment, arm activity, quality of life, and overall disability. Study feasibility will be evaluated in part by recording attendance and comparing the number of completed intervention sessions with the number of scheduled sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neurofeedback group | Experimental | Other: fNIRS-neurofeedbackThis group will receive visual feedback of the fNIRS signal |
| Control group | Active comparator | Other: ControlThis group will not receive visual feedback |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stroke patients in the subacute phase
- upper extremity hemiparesis (< or =4/5 manual muscle grade in at least one of the major upper extremity muscles)
- Modified Rankin Scale (mRS) score of <2 pre-stroke
- Able to communicate in English
- Able to comprehend instructions and provide informed consent
Key exclusion criteria (3 listed)
- cognitive deficits
- have another known neurological or serious medical condition (e.g., Parkinson's, active cancer, etc.)
- Present with severe receptive aphasia which would compromise their ability to provide informed consent
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 |
|---|---|---|
| fNIRS-neurofeedbackThis group receives visual feedback of the fNIRS signal | Other | neurofeedback group |
| ControlControl group | Other | Control group |
Primary outcome
functional Near Infrared Spectroscopy (fNIRS) amplitude over the motor cortex
Time frame: Session 8 (up to 6 months post stroke)
brain activity
8 secondary outcomes
National Institutes of Health Stroke Scale
Time frame: Pre-intervention
Fugl-Meyer Upper Extremity
Time frame: Session 8 (up to 6 months post stroke)
Action Research Arm Test
Time frame: Session 8 (up to 6 months post stroke)
EuroQol Five Dimensions
Time frame: Session 8 (up to 6 months post stroke)
Modified Rankin Scale
Time frame: Session 8 (up to 6 months post stroke)
fNIRS amplitude of other motor and prefrontal areas
Time frame: Session 8 (up to 6 months post stroke)
Electromyography (EMG) over the wrist, elbow, and shoulder muscles
Time frame: Session 8 (up to 6 months post stroke)
Number of attended sessions
Time frame: Sessions 1 through to Session 8 (from enrolment up to 6 months post stroke)
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 15 Oct 2026.
- Individual participant dataSharing planned: Undecided. At minimum, summary statistics will be provided in the primary outcomes paper.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing fNIRS-neurofeedback in people with Stroke, run by Sue Peters.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Sue Peters, PT, PhD (519-646-6100 ext. 45784, sue.peters@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional Near Infrared Spectroscopy (fNIRS) amplitude over the motor cortex (time frame: Session 8 (up to 6 months post stroke)). 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 15 Oct 2026.