NCT07911384

Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke

StatusNot Yet Recruiting

PhaseNot applicable

SponsorMarta Sofia Ramos Torres

Primary completionApr 2028 (estimated)

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Record History

All 1 version: 1 with changes below.

Oct 29, 2026 Study First Submitted

Endpoints

Primary

Change in Fugl-Meyer Assessment for the Upper Extremity (FM-UE) Score

Timeframe: Baseline (T0) and immediately after the 4-week intervention (T1)

Secondary (3)

Change in Action Research Arm Test (ARAT) Score

Change in Wrist and Finger Extensor Muscle Strength (MRC Scale)

Change in Functional Independence Measure (FIM) Total Score

Arms and interventions

BMI-Assisted RehabilitationExperimental

Participants will receive standard multidisciplinary inpatient stroke rehabilitation plus 12 additional sessions over four weeks of brain-machine interface (BMI) training using EEG-based motor imagery or attempted movement, immersive virtual reality neurofeedback, and neuromuscular electrical stimulation (NMES) of the affected wrist and finger extensors. NMES will be triggered by designated movement cues, independently of EEG classifier output.

NMES ControlActive comparator

Participants will receive standard multidisciplinary inpatient stroke rehabilitation plus 12 additional sessions over four weeks of neuromuscular electrical stimulation (NMES) targeting the affected wrist and finger extensors. Stimulation parameters, number of stimulations, and therapist contact time will be comparable to the experimental group. No brain-machine interface training, virtual reality neurofeedback, or structured motor imagery will be provided.

Devices: Brain-Machine Interface Training With Virtual Reality and NMES, Neuromuscular Electrical Stimulation

Sites

1 site in 1 country

Centro de Reabilitação do Norte (CRN), Unidade Local de Saúde de Gaia e EspinhoVila Nova de Gaia, Porto District, Portugal

About this trial

Stroke is a major cause of long-term disability, and many stroke survivors experience persistent difficulties moving and using their affected arm and hand. Improving upper limb function is an important goal of stroke rehabilitation. This study aims to investigate whether adding brain-machine interface (BMI) training to conventional rehabilitation improves upper limb motor recovery after stroke. The BMI system uses electroencephalography (EEG) to detect brain activity associated with imagined or attempted hand movements and provides visual feedback through virtual reality (VR). Neuromuscular electrical stimulation (NMES) is also applied to the affected wrist and finger extensor muscles during designated movement tasks. A total of 68 adults undergoing inpatient rehabilitation after ischemic stroke will be randomly assigned to one of two groups. Both groups will receive standard rehabilitation. The experimental group will additionally receive BMI training with VR feedback and NMES, while the control group will receive NMES without BMI or VR feedback. Both groups will complete 12 additional sessions over four weeks. The main outcome will be the change in upper limb motor impairment, assessed using the Fugl-Meyer Assessment for the Upper Extremity (FM-UE). Other measures will assess upper limb activity, muscle strength, and functional independence. The study will help determine whether BMI-assisted training provides additional benefits compared with NMES alone when combined with conventional inpatient stroke rehabilitation.

Trial details

Enrollment: 68 participants (estimated)
Started: Dec 2026
Study completion: May 2028 (estimated)
Eligibility: 18 and older, all sexes, no healthy volunteers
Design: Interventional, randomized, single blind, treatment
Oversight: No data monitoring committee
Conditions: Ischemic Stroke
Collaborators: Unidade Local de Saude de Gaia e Espinho EPE, Instituto de Biomedicina da Universidade de Aveiro
Official title: Post-Stroke Upper Limb Motor Rehabilitation Using a Brain-Machine Interface With Virtual Reality-Based Neurofeedback: Study Protocol for a Randomized Controlled Trial
First posted: Nov 2, 2026
Registry updated: Nov 2, 2026
Last verified: Oct 2026

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