Ischemic StrokeNCT07911384
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
A study testing Brain-Machine Interface Training With Virtual Reality and NMES and Neuromuscular Electrical Stimulation in people with Ischemic Stroke, run by Marta Sofia Ramos Torres at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Brain-Machine Interface Training With Virtual Reality and NMES and Neuromuscular Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePortugal
- Study dates
- Dec 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cognitive or language impairment preventing comprehension or execution of study instructions.
- Hemispatial neglect.
- Severe sensory impairment affecting the paretic upper limb.
- Ideomotor apraxia.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Centro de Reabilitação do Norte (CRN), Unidade Local de Saúde de Gaia e Espinho
Vila Nova de Gaia, Porto District, 4405-565
Marta R Torres, MD, +351935900164, marta.torres@ulsge.min-saude.pt
Marta R Torres, MD
About this study
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
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.
Read more
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.
- Conditions
- Ischemic Stroke
- Being tested
- Brain-Machine Interface Training With Virtual Reality and NMES, Neuromuscular Electrical Stimulation
- Keywords
- Brain-Machine Interface, Brain-Computer Interface, Stroke Rehabilitation, Upper Limb Rehabilitation, Motor Imagery, Virtual Reality, Neuromuscular Electrical Stimulation, Neurofeedback
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-Machine Interface Training With Virtual Reality and NMESDevice
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.
Neuromuscular Electrical StimulationDevice
Also called NMES
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.
| Study group | Role | What they receive |
|---|---|---|
| BMI-Assisted Rehabilitation | Experimental | 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. Receives: Device: Brain-Machine Interface Training With Virtual Reality and NMES |
| NMES Control | Active 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. Receives: Device: Neuromuscular Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment for the Upper Extremity (FM-UE) Score
Change in upper limb motor impairment assessed using the Fugl-Meyer Assessment for the Upper Extremity (FM-UE). Scores range from 0 to 66, with higher scores indicating better motor function. The outcome is calculated as the post-intervention score minus the baseline score.
Measured: Baseline (T0) and immediately after the 4-week intervention (T1)
Secondary outcomes (3)
Change in Action Research Arm Test (ARAT) Score
Change in upper limb activity assessed using the Action Research Arm Test (ARAT). The test evaluates grasp, grip, pinch, and gross movement. Total scores range from 0 to 57, with higher scores indicating better upper limb performance. The outcome is calculated as the post-intervention score minus the baseline score.
Measured: Baseline (T0) and immediately after the 4-week intervention (T1)
Change in Wrist and Finger Extensor Muscle Strength (MRC Scale)
Change in muscle strength of the affected wrist and finger extensors, assessed using the Medical Research Council (MRC) scale. Each muscle group is graded from 0 (no visible or palpable contraction) to 5 (normal strength), with higher grades indicating greater muscle strength. Changes from baseline to post-intervention will be assessed.
Measured: Baseline (T0) and immediately after the 4-week intervention (T1)
Change in Functional Independence Measure (FIM) Total Score
Change in functional independence assessed using the Functional Independence Measure (FIM). The scale comprises 18 items evaluating motor and cognitive aspects of daily functioning. Total scores range from 18 to 126, with higher scores indicating greater functional independence. The outcome is calculated as the post-intervention score minus the baseline score.
Measured: Baseline (T0) and immediately after the 4-week intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marta Sofia Ramos Torres
- Sponsor type
- University, hospital or other
- Collaborators
- Unidade Local de Saude de Gaia e Espinho EPE, Instituto de Biomedicina da Universidade de Aveiro
- Responsible party
- Sponsor-investigator, Marta Sofia Ramos Torres, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911384
- Sponsor's protocol ID
- BMI-STROKE-2026
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Study data will be stored securely, with access restricted to the principal investigator, in accordance with the approved data protection procedures.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07911384
- Acronym / sponsor ID
- BMI-STROKE-2026
- Conditions
- Ischemic Stroke
- Keywords
- Brain-Machine Interface, Brain-Computer Interface, Stroke Rehabilitation, Upper Limb Rehabilitation, Motor Imagery, Virtual Reality, Neuromuscular Electrical Stimulation, Neurofeedback
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Marta Sofia Ramos TorresUniversity, hospital or other
- Collaborators
- Unidade Local de Saude de Gaia e Espinho EPE, Instituto de Biomedicina da Universidade de Aveiro
- Study start
- Dec 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMI-Assisted Rehabilitation | Experimental | Device: Brain-Machine Interface Training With Virtual Reality and NMESParticipants 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 Control | Active comparator | Device: Neuromuscular Electrical StimulationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- Cognitive or language impairment preventing comprehension or execution of study instructions.
- Hemispatial neglect.
- Severe sensory impairment affecting the paretic upper limb.
- Ideomotor apraxia.
- Other neurological or musculoskeletal conditions significantly affecting upper limb motor function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain-Machine Interface Training With Virtual Reality and NMESParticipants 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 | BMI-Assisted Rehabilitation |
| Neuromuscular Electrical StimulationAlso: NMESParticipants 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. | Device | NMES Control |
Primary outcome
Change in Fugl-Meyer Assessment for the Upper Extremity (FM-UE) Score
Time frame: Baseline (T0) and immediately after the 4-week intervention (T1)
Change in upper limb motor impairment assessed using the Fugl-Meyer Assessment for the Upper Extremity (FM-UE). Scores range from 0 to 66, with higher scores indicating better motor function. The outcome is calculated as the post-intervention score minus the baseline score.
3 secondary outcomes
Change in Action Research Arm Test (ARAT) Score
Time frame: Baseline (T0) and immediately after the 4-week intervention (T1)
Change in Wrist and Finger Extensor Muscle Strength (MRC Scale)
Time frame: Baseline (T0) and immediately after the 4-week intervention (T1)
Change in Functional Independence Measure (FIM) Total Score
Time frame: Baseline (T0) and immediately after the 4-week intervention (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Study data will be stored securely, with access restricted to the principal investigator, in accordance with the approved data protection procedures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-Machine Interface Training With Virtual Reality and NMES and Neuromuscular Electrical Stimulation in people with Ischemic Stroke, run by Marta Sofia Ramos Torres at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta R Torres, MD (+351935900164, marta.torres@ulsge.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Assessment for the Upper Extremity (FM-UE) Score (time frame: Baseline (T0) and immediately after the 4-week intervention (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.