Brain-computer Interface (BCI)-Guided Upper Limb Neurorehabilitation for Acute Stroke With the recoveriX System

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-80
SponsorTan Tock Seng Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Presence of previous diagnosis of stroke

Implanted pacemaker or continuous infusion pump

History of seizures or past history of epilepsy

Recent neurosurgery

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
2

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

Time frame
Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
3

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.

Time frame
Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)
4

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).

Time frame
Weeks 0 (baseline), 3-4 (end training), 12, and 24 (follow-up)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tan Tock Seng Hospital

Lead sponsor

National Neuroscience Institute

Collaborator

This trial is not recruiting at the moment. You can still explore other options: