Clinical Research Directory

Lifescapes System in Post-stroke Hand Recovery

Sponsor: National University Hospital, Singapore

Summary

Stroke is a leading cause of long-term disability, with 30-60% of survivors remaining unable to use their affected arms after discharge. Existing rehabilitation approaches such as motor imagery, robotic assistance, and neuromodulation have shown limited effectiveness for hand motor recovery. The Lifescapes system is a novel EEG-based brain-computer interface that combines motor imagery practice, biofeedback, neuromuscular electrical stimulation, and robotic assistance to help post-stroke patients with severe hand paralysis. A recent clinical trial in 40 patients demonstrated promising improvements in motor function with the Lifescapes system, supporting its potential as a rehabilitation tool. This study aims to evaluate whether Lifescapes therapy delivered with reduced therapist supervision can improve upper-limb motor function in stroke patients, and whether such an approach is operationally feasible in the local clinical setting. 32 participants will be recruited from Alexandra Hospital and National University Hospital over 2 years. Participants must be aged 21-80, have had a stroke between 8 weeks and 5 years before enrolment, and have moderate to severe upper-limb impairment. They must be able to give informed consent and follow instructions. Participants are excluded if they are pregnant, have bilateral stroke, severe finger spasticity (MAS \>2), implanted stimulators or pacemakers, recent seizures within 90 days, or any unstable medical conditions. Participants will complete 16 sessions of Lifescapes BCI training over 4-8 weeks (2-4 sessions per week, approximately 30 minutes each). Therapist assistance will be progressively reduced based on each participant's ability, though a therapist remains present throughout. Each Lifescapes session is followed by a 30-minute GRASP session, a standardised self-directed arm and hand exercise programme prescribed by an occupational therapist. Participants will attend up to 21 visits over 5-6 months. Outcomes are assessed at 6 timepoints: pre-baseline (2-4 weeks before starting), baseline, after the 8th session, after the 16th session, and at 1-month and 3-month follow-up (the latter optional). Outcome measures include the Fugl-Meyer Assessment for the upper extremity (FMA-UE), Action Research Arm Test (ARAT), grip and pinch strength, Modified Ashworth Scale (MAS), Motor Activity Log-14 (MAL-14), EQ-5D-5L quality of life measure, and optional TMS measurement of corticospinal excitability.

Official title: Effectiveness and Feasibility of a Brain-computer Interface Based Neurofeedback System With Reduced Therapist Supervision for Hand Motor Recovery in Stroke Patients

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