Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07911384
NA

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

Sponsor: Marta Sofia Ramos Torres

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2026-12

Completion Date

2028-05

Last Updated

2026-11-02

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Brain-Machine Interface Training With Virtual Reality and NMES

Participants will undergo 12 sessions over four weeks (three sessions per week) of EEG-based brain-machine interface (BMI) training combined with immersive virtual reality (VR) neurofeedback and neuromuscular electrical stimulation (NMES). Participants will perform kinesthetic motor imagery or attempted movements of the affected wrist and fingers. EEG-based classification will provide real-time visual neurofeedback. NMES will be delivered to the affected wrist and finger extensors during designated movement cues, independently of EEG classifier output. Each session includes calibration and real-time feedback training, with 40 electrical stimulations.

DEVICE

Neuromuscular Electrical Stimulation

Participants will receive 12 sessions over four weeks (three sessions per week) of neuromuscular electrical stimulation (NMES) targeting the affected wrist and finger extensors. Each session will include 40 electrical stimulations delivered at regular intervals over approximately 20 minutes. Stimulation parameters will match those used in the experimental group. No brain-machine interface training, virtual reality neurofeedback, or structured motor imagery will be provided.

Locations (1)

Centro de Reabilitação do Norte (CRN), Unidade Local de Saúde de Gaia e Espinho

Vila Nova de Gaia, Porto District, Portugal