StrokeNCT07858006
Brain-computer Interface (BCI)-Guided Upper Limb Neurorehabilitation for Acute Stroke With the recoveriX System
A study testing BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX) in people with Stroke, run by Tan Tock Seng Hospital.
Trial summary
Stroke is a leading cause of neurological disability and upper limb impairment. While conventional rehabilitation options exist, brain-computer interface (BCI)-based neurorehabilitation has emerged as a promising approach that records and decodes neural signals to drive rehabilitation devices or functional electrical… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to Dec 2027
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between age 21 to 80 years with hemorrhagic or ischemic stroke
- Stroke onset within 2-12 weeks
- Any demonstrated voluntary finger flexion or finger extension Oxford Medical Research Council (MRC) grade 0 to 4 (total 5)
- Montreal Cognitive Assessment (MoCA) > 20
- Ability to understand written and spoken instructions, as well as stable medical and neurological status.
Who cannot join
- Presence of previous diagnosis of stroke
- Implanted pacemaker or continuous infusion pump
- History of seizures or past history of epilepsy
- Recent neurosurgery
- Medical instability deemed by study team
- Severe blindness
Show all 15Show fewer
- Anticipated life expectancy <6 months
- Hemodialysis
- Inability to obey 1-step commands
- Severe aphasia, or dysarthria
- Severe arm/hand pain (Visual Analog Scale >4/10) or severe hemi anesthesia or spasticity in the paretic arm (modified Ashworth scale MAS >2, total 4)
- Fixed shoulder or finger joint contractures, active arthritis in any upper limb joint
- Inability to tolerate upright supported sitting posture for at least 45 minutes
- Disorders of consciousness or altered arousal states precluding active participation in the task.
- Pregnant women will be excluded from the study as the safety of FES (electrical stimulations) on foetus is unclear.
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
Stroke is a leading cause of neurological disability and upper limb impairment. While conventional rehabilitation options exist, brain-computer interface (BCI)-based neurorehabilitation has emerged as a promising approach that records and decodes neural signals to drive rehabilitation devices or functional electrical stimulation. By re-coupling cortical motor intent to limb movement, BCI systems restore closed-loop neurofeedback and facilitate neuroplasticity through residual neural pathways. Motor intent is detected non-invasively via scalp electroencephalography (EEG), using characteristic changes in mu and beta rhythm activity known as event-related desynchronisation (ERD). This study aims to investigate how these electrophysiological signals change over time following stroke and their implications for BCI-based rehabilitation.
Read the detailed description
Stroke is a leading cause of neurological disability, resulting in significant upper limb impairment. Current rehabilitation approaches include conventional occupational therapy, constraint-induced movement therapy, and robot-assisted therapy. Brain-computer interface (BCI)-based neurorehabilitation has emerged as a promising addition, whereby neural signals are recorded, decoded to determine motor intent, and used to drive external devices or functional electrical stimulation of the patient's own muscles.
A key mechanism underlying BCI-based rehabilitation is the restoration of closed-loop neurofeedback. Conventional rehabilitation lacks a direct link between a patient's volitional intent and limb movement. BCI systems address this by re-coupling cortical motor signals to end-effector activity, bypassing lesioned neural pathways and facilitating Hebbian neuroplasticity. Sensory feedback from limb movement further reinforces this closed loop, promoting recovery of motor function through residual and alternative neural pathways.
Motor intent is measured non-invasively using scalp electroencephalography (EEG), which captures oscillatory brain activity - particularly the mu (8-13 Hz) and beta (13-30 Hz) rhythms - that correlate with motor preparation and execution. During movement intent, characteristic reductions in these rhythms, known as event-related desynchronisation (ERD), can be detected algorithmically and used to control rehabilitation devices. Following stroke, these electrophysiological signals are known to be altered, though how they evolve over time remains an open question that this study aims to address.
- Conditions
- Stroke
- Being tested
- BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX)
- Keywords
- Brain Computer Interface
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX)Device
Participants will undergo BCI-based neurorehabilitation using the FDA-approved recoveriX system, comprising a wet-electrode EEG cap, EEG signal processing software, and a functional electrical stimulator (FES). Treatment consists of up to 12 sessions over 3 to 4 weeks (2-3 sessions/week), supervised by a trained study team member, alongside usual inpatient rehabilitation.
Each session involves motor imagery (MI) of finger extension across 3 blocks of 80 trials (240 total). Each trial begins with a 2-second baseline, followed by an auditory and visual cue to imagine finger extension for 5 seconds. If MI is detected (assessed every 200 ms), FES is delivered to the finger extensors (50 Hz, 300 µs pulse width), titrated to produce movement without pain. Real-time feedback is provided, and a session report is generated for review. Within 2 hours of each session, participants undergo 45 minutes of conventional standard-of-care occupational therapy.
| Study group | Role | What they receive |
|---|---|---|
| BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX) | Experimental | Not described Receives: Device: BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM)
An 18-item clinical assessment tool used to measure a patient's level of disability and determine how much assistance they require to perform basic activities of daily living. Minimum score: 18 (Patient requires total assistance for all 18 tasks), maximum score: Maximum score: 126 (Patient is completely independent in all 18 tasks), with higher score indicating better function.
Measured: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
Fugl-Meyer Motor Assessment (FMA) scale
Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function
Measured: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
Action Research Arm Test (ARAT) Score
Functional and dexterity score in the affected arm evaluated using 19 tests of motor function across 4 subsets; minimum score = 0, maximum score = 57, with higher score indicating better function.
Measured: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
Stroke Impact Scale v3.0
A patient-reported questionnaire used to evaluate how a stroke impacts health and quality of life. Patients rate how difficult tasks are on a 5-point Likert scale (1 = "could not do it at all" to 5 = "not difficult at all"). Scores for each domain are then standardized to range from 0 to 100, with higher scores indicating better functioning and a higher quality of life. An additional visual scale asks patients to estimate their overall stroke recovery from 0 (no recovery) to 100 (full recovery).
Measured: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
EQ-5D-5L
EQ-5D-5L is a standardized, patient-reported questionnaire used globally to evaluate health-related quality of life. It measures 5 dimensions of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each area features 5 severity levels, from "no problems" to "extreme problems".
Measured: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Neuroscience Institute
- Responsible party
- Sponsor
- Investigators
- Yu Tung Lo, Principal investigator, National Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858006
- Sponsor's protocol ID
- ECOS ref: 2024-3186
- Status last verified
- Jun 2026
- First submitted
- 29 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-computer Interface (BCI)-Guided Upper Limb Neurorehabilitation for Acute Stroke With the recoveriX System
- ClinicalTrials.gov ID
- NCT07858006
- Acronym / sponsor ID
- ECOS ref: 2024-3186
- Conditions
- Stroke
- Keywords
- Brain Computer Interface
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- National Neuroscience Institute
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 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.
Stroke is a leading cause of neurological disability and upper limb impairment. While conventional rehabilitation options exist, brain-computer interface (BCI)-based neurorehabilitation has emerged as a promising approach that records and decodes neural signals to drive rehabilitation devices or functional electrical stimulation. By re-coupling cortical motor intent to limb movement, BCI systems restore closed-loop neurofeedback and facilitate neuroplasticity through residual neural pathways. Motor intent is detected non-invasively via scalp electroencephalography (EEG), using characteristic changes in mu and beta rhythm activity known as event-related desynchronisation (ERD). This study aims to investigate how these electrophysiological signals change over time following stroke and their implications for BCI-based rehabilitation.
Detailed description
Stroke is a leading cause of neurological disability, resulting in significant upper limb impairment. Current rehabilitation approaches include conventional occupational therapy, constraint-induced movement therapy, and robot-assisted therapy. Brain-computer interface (BCI)-based neurorehabilitation has emerged as a promising addition, whereby neural signals are recorded, decoded to determine motor intent, and used to drive external devices or functional electrical stimulation of the patient's own muscles.
A key mechanism underlying BCI-based rehabilitation is the restoration of closed-loop neurofeedback. Conventional rehabilitation lacks a direct link between a patient's volitional intent and limb movement. BCI systems address this by re-coupling cortical motor signals to end-effector activity, bypassing lesioned neural pathways and facilitating Hebbian neuroplasticity. Sensory feedback from limb movement further reinforces this closed loop, promoting recovery of motor function through residual and alternative neural pathways.
Motor intent is measured non-invasively using scalp electroencephalography (EEG), which captures oscillatory brain activity - particularly the mu (8-13 Hz) and beta (13-30 Hz) rhythms - that correlate with motor preparation and execution. During movement intent, characteristic reductions in these rhythms, known as event-related desynchronisation (ERD), can be detected algorithmically and used to control rehabilitation devices. Following stroke, these electrophysiological signals are known to be altered, though how they evolve over time remains an open question that this study aims to address.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX) | Experimental | Device: BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults between age 21 to 80 years with hemorrhagic or ischemic stroke
- Stroke onset within 2-12 weeks
- Any demonstrated voluntary finger flexion or finger extension Oxford Medical Research Council (MRC) grade 0 to 4 (total 5)
- Montreal Cognitive Assessment (MoCA) > 20
- Ability to understand written and spoken instructions, as well as stable medical and neurological status.
Key exclusion criteria (15 listed)
- Presence of previous diagnosis of stroke
- Implanted pacemaker or continuous infusion pump
- History of seizures or past history of epilepsy
- Recent neurosurgery
- Medical instability deemed by study team
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 |
|---|---|---|
| BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX)Participants will undergo BCI-based neurorehabilitation using the FDA-approved recoveriX system, comprising a wet-electrode EEG cap, EEG signal processing software, and a functional electrical stimulator (FES). Treatment consists of up to 12 sessions over 3 to 4 weeks (2-3 sessions/week), supervised by a trained study team member, alongside usual inpatient rehabilitation. Each session involves motor imagery (MI) of finger extension across 3 blocks of 80 trials (240 total). Each trial begins with a 2-second baseline, followed by an auditory and visual cue to imagine finger extension for 5 seconds. If MI is detected (assessed every 200 ms), FES is delivered to the finger extensors (50 Hz, 300 µs pulse width), titrated to produce movement without pain. Real-time feedback is provided, and a session report is generated for review. Within 2 hours of each session, participants undergo 45 minutes of conventional standard-of-care occupational therapy. | Device | BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX) |
Primary outcome
Functional Independence Measure (FIM)
Time frame: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
An 18-item clinical assessment tool used to measure a patient's level of disability and determine how much assistance they require to perform basic activities of daily living. Minimum score: 18 (Patient requires total assistance for all 18 tasks), maximum score: Maximum score: 126 (Patient is completely independent in all 18 tasks), with higher score indicating better function.
Fugl-Meyer Motor Assessment (FMA) scale
Time frame: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function
Action Research Arm Test (ARAT) Score
Time frame: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
Functional and dexterity score in the affected arm evaluated using 19 tests of motor function across 4 subsets; minimum score = 0, maximum score = 57, with higher score indicating better function.
Stroke Impact Scale v3.0
Time frame: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
A patient-reported questionnaire used to evaluate how a stroke impacts health and quality of life. Patients rate how difficult tasks are on a 5-point Likert scale (1 = "could not do it at all" to 5 = "not difficult at all"). Scores for each domain are then standardized to range from 0 to 100, with higher scores indicating better functioning and a higher quality of life. An additional visual scale asks patients to estimate their overall stroke recovery from 0 (no recovery) to 100 (full recovery).
EQ-5D-5L
Time frame: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
EQ-5D-5L is a standardized, patient-reported questionnaire used globally to evaluate health-related quality of life. It measures 5 dimensions of health: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each area features 5 severity levels, from "no problems" to "extreme problems".
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 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Yu Tung Lo principal investigator
National Neuroscience Institute
Questions about this trial
What is this clinical trial studying?
A study testing BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX) in people with Stroke, run by Tan Tock Seng Hospital.
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 15 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 7 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 Xin Yi Lim (63596312, xin.yi.lim1@nhghealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measure (FIM) (time frame: Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)). The study lists 5 primary outcomes in all. 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 7 Oct 2026.