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NOT YET RECRUITING
NCT07858006
NA

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

Sponsor: Tan Tock Seng Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

21 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-10-01

Completion Date

2027-12

Last Updated

2026-10-05

Healthy Volunteers

No

Conditions

Interventions

DEVICE

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 15 sessions over 3 to 4 weeks (4-5 sessions/week), supervised by a certified research occupational therapist, 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 minutes of each session, participants undergo 45 minutes of conventional standard-of-care occupational therapy.