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

NCT07858006 | Not Yet Recruiting

• 1 other identifier: ECOS ref: 2024-3186
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Stroke

Keywords

Brain Computer Interface

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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.

  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).

  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".

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

Study Arms (1)

BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX)

EXPERIMENTAL

Device: BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX)

Interventions

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.

BCI-Based Neurorehabilitation with Functional Electrical Stimulation (recoveriX)

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• National Neuroscience Institute: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yu Tung Lo

  National Neuroscience Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Yi Lim

CONTACT

63596312; xin.yi.lim1@nhghealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2026
• First Posted: October 5, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share