Lifescapes System in Post-stroke Hand Recovery

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

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07784920
Lead Sponsor: National University Hospital, SingaporeOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 32Estimated
Last Update Posted: Aug 25, 2026Actual
Start Date: Oct 1, 2026Estimated
Primary Completion Date: Sep 30, 2027Estimated
Completion Date: Sep 30, 2027Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

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

Conditions

The medical conditions and diseases this study investigates.

Stroke

Interventions

The treatments and procedures being evaluated in this study.

Lifescapes

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Age 21-80 years old;

First-ever or recurrent ischemic or haemorrhagic stroke;

Stroke onset between 8 weeks and 5 years prior to enrolment;

Moderate to severe unilateral upper-limb motor impairment following stroke, defined as a baseline upper-extremity Fugal-Meyer Assessment (FMA-UE) score <47, and Manual Muscle Testing (MMT) of finger extensor ≤2;

Being able to provide informed consent, understand and follow verbal instructions.

Having sufficient visual acuity to scan full computer screen.

Exclusion Criteria:

Pregnant or breastfeeding women;

Bilateral stroke;

Modified Ashworth Scale (MAS) of finger flexors >2;

Use of a pacemaker or of other implanted stimulators;

History of seizures within 90 days before enrolment;

Impossible to record EEG because of skin status or skull deformity;

Sensorimotor disturbance due to other causes other than stroke;

Medically unstable or uncontrolled conditions that may compromise safety or the ability to complete scheduled visits.

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Peijing Su, MBBSContact

peijing_su@nuhs.edu.sg65 69082222

Locations

Where the study is run and whether each site is currently recruiting.

Alexandra Hospital

Singapore, Singapore

Collaborators

The organizations and people involved in this study.

Lead Sponsor: National University Hospital, SingaporeOTHER
Collaborators

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Other registered studies that closely resemble this one.

Detailed Description

Background

Stroke is a leading cause of adult long-term disability, with 30-60% of stroke survivors remaining unable to use their affected arms after discharge. While many interventional approaches have been tested - including motor imagery, robotic movement assistance, and neuromodulation - therapeutic efficacy remains limited for hand motor function. The Lifescapes system is a novel EEG-based brain-computer interface (BCI) neurofeedback system that facilitates motor imagery practice in post-stroke patients with severe hemiparesis, integrating biofeedback, neuromuscular electrical stimulation (NMES), and robot-aided sensorimotor stimulation. By triggering NMES and robotic assistance contingent on sensorimotor rhythm event-related desynchronisation (SMR-ERD) magnitude, the system enables voluntary modulation of endogenous sensorimotor activities in the ipsilesional hemisphere. A recent RCT in 40 chronic post-stroke hemiplegic patients demonstrated a significant between-group difference in Fugl-Meyer Assessment scores in favour of the Lifescapes group, supporting its potential as an adjunctive rehabilitation approach.

Study Objectives

The primary objective is to evaluate the effectiveness of Lifescapes therapy with reduced therapist supervision in improving upper-limb motor function in sub-acute and chronic stroke patients with moderate to severe upper limb paresis. The secondary objective is to evaluate the operational feasibility of Lifescapes with reduced therapist supervision in the local context. It is hypothesised that Lifescapes therapy with reduced therapist supervision is feasible in this study population and will quantitatively improve hand motor function.

Study Design

This is a single-arm, prospective study to evaluate the real-world effectiveness and feasibility of Lifescapes with reduced therapist supervision for post-stroke upper-limb rehabilitation. 32 subjects will be recruited from Alexandra Hospital (AH) and National University Hospital (NUH) over an estimated study duration of 2 years.

Participants

Inclusion criteria are: age 21-80 years; first-ever or recurrent ischemic or haemorrhagic stroke; stroke onset between 8 weeks and 5 years prior to enrolment; moderate to severe unilateral upper-limb motor impairment defined as a baseline FMA-UE score <47 and Manual Muscle Testing (MMT) of finger extensor ≤2; ability to provide informed consent and follow verbal instructions; and sufficient visual acuity to scan a full computer screen.

Exclusion criteria include: pregnant or breastfeeding women; bilateral stroke; Modified Ashworth Scale (MAS) of finger flexors >2; use of a pacemaker or other implanted stimulators; history of seizures within 90 days before enrolment; inability to record EEG due to skin status or skull deformity; sensorimotor disturbance due to causes other than stroke; and medically unstable or uncontrolled conditions that may compromise safety or the ability to complete scheduled visits.

Intervention

Eligible subjects will undergo 16 sessions of MI-BCI training with NMES and robotic movement assistance using the paralysed hand through the Lifescapes device. The intervention course must be completed within 4-8 weeks from the first to the last session, at a target frequency of 2-4 sessions per week. Therapist assistance during each Lifescapes session will be reduced progressively according to individual ability, though a therapist will remain present throughout in case assistance is needed. Each session is approximately 30 minutes.

Following each Lifescapes session, participants will complete a standardised occupational therapy programme - GRASP (Graded Repetitive Arm Supplementary Program) - supervised by a trained research staff member. All occupational tasks will be selected from the GRASP task pool and prescribed by an occupational therapist. Each GRASP session will take approximately 30 minutes.

Study Visits and Assessments

There will be up to 21 study visits over 5-6 months, comprising 16 intervention sessions and 6 rounds of assessment at the following timepoints: 2-4 weeks before the first Lifescapes session (pre-baseline), before the first session (baseline), after the 8th session (interim), after the 16th session (post), 1 month after the 16th session (1-month follow-up), and 3 months after the 16th session (3-month follow-up, optional).

Outcome Measures

Clinical outcomes assessed at each timepoint include: Upper Extremity Fugl-Meyer Assessment (FMA-UE); Action Research Arm Test (ARAT); grip and pinch strength measured by dynamometer; Modified Ashworth Scale (MAS) of the affected upper limb muscles; Motor Activity Log-14 (MAL-14); EQ-5D-5L; and corticospinal excitability measurement by TMS (optional).