NCT07911384Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Post-Stroke Upper Limb Motor Rehabilitation Using a Brain-Machine Interface With Virtual Reality-Based Neurofeedback: Study Protocol for a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- First submitted
- 25 Oct 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Marta Sofia Ramos Torres
- Diseases
- Stroke
- NCT number
- NCT07911384
What you commit to
- Study type: Interventional
- Planned participants: 68
- From 1 Dec 2026 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cognitive or language impairment preventing comprehension or execution of study instructions.
- Severe sensory impairment affecting the paretic upper limb.
- Other neurological or musculoskeletal conditions significantly affecting upper limb motor function.
- Life-threatening or clinically unstable medical conditions that would compromise safe participation in the intervention.
Other
- Hemispatial neglect.
- Ideomotor apraxia.
Who the study is looking for
- Age 18 years or older.
- First-ever unilateral ischemic stroke involving the anterior cerebral circulation.
- Time since stroke onset between 2 weeks and 5 months.
- Admission to the inpatient stroke rehabilitation program at the North Rehabilitation Center (Centro de Reabilitação do Norte), Local Health Unit Gaia Espinho, Portugal
- Upper limb motor impairment, defined as a Fugl-Meyer Assessment for the Upper Extremity (FM-UE) score below 47.
- Medically stable and able to tolerate seated training sessions lasting approximately 60 minutes.
- Ability to understand and follow the instructions required to participate in the intervention.
- Provision of written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Reabilitação do Norte (CRN), Unidade Local de Saúde de Gaia e Espinho Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.