An interventional study of fNIRS-neurofeedback and Control in Stroke, sponsored by Sue Peters. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Sue Peters · Not applicable, Interventional, and Treatment
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.
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Sue Peters is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This group will receive visual feedback of the fNIRS signal
Other: fNIRS-neurofeedback
This group will not receive visual feedback
Other: Control
This group receives visual feedback of the fNIRS signal
Control group
functional Near Infrared Spectroscopy (fNIRS) amplitude over the motor cortex
brain activity
Time frame: Session 8 (up to 6 months post stroke)
National Institutes of Health Stroke Scale
stroke severity (0=no deficit, 42=maximum deficit)
Time frame: Pre-intervention
Fugl-Meyer Upper Extremity
motor impairment, (0=maximum impairment, 66=no impairment)
Time frame: Session 8 (up to 6 months post stroke)
Action Research Arm Test
motor activity (0=maximum impairment, 57=no impairment)
Time frame: Session 8 (up to 6 months post stroke)
EuroQol Five Dimensions
quality of life (5=best quality of life, 25=lowest quality of life)
Time frame: Session 8 (up to 6 months post stroke)
Modified Rankin Scale
disability (1=no disability, 6=dead)
Time frame: Session 8 (up to 6 months post stroke)
fNIRS amplitude of other motor and prefrontal areas
mechanistic measure
Time frame: Session 8 (up to 6 months post stroke)
Electromyography (EMG) over the wrist, elbow, and shoulder muscles
muscle activity
Time frame: Session 8 (up to 6 months post stroke)
Number of attended sessions
feasibility
Time frame: Sessions 1 through to Session 8 (from enrolment up to 6 months post stroke)
No study locations are listed for this record.
Plan to share: Undecided — At minimum, summary statistics will be provided in the primary outcomes paper.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sue Peters