An interventional study of Brain-Machine Interface Training With Virtual Reality and NMES and Neuromuscular Electrical Stimulation in Ischemic Stroke, sponsored by Marta Sofia Ramos Torres. Not yet recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Marta Sofia Ramos Torres · Not applicable, Interventional, and Treatment
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 68 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →This is the only study on the registry with Marta Sofia Ramos Torres as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Brain-Machine Interface Training With Virtual Reality and NMES
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.
Device: Neuromuscular Electrical Stimulation
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.
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.
Also known as: NMES
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.
Time frame: Baseline (T0) and immediately after the 4-week intervention (T1)
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (T0) and immediately after the 4-week intervention (T1)
Change in EEG Laterality Index (Exploratory)
Exploratory assessment of changes in hemispheric asymmetry of motor-related EEG activity, using a laterality index derived from electrodes C3 and C4 during motor imagery or attempted movement. This is an EEG-derived physiological index rather than a clinical rating scale. Its interpretation depends on the direction and magnitude of hemispheric asymmetry, rather than higher values necessarily indicating better or worse clinical outcomes.
Time frame: Baseline (T0) and immediately after the 4-week intervention (T1)
Change in Spasticity (Modified Ashworth Scale)
Exploratory assessment of changes in spasticity of the affected upper limb using the Modified Ashworth Scale (MAS), which grades resistance to passive muscle stretch during rapid passive movement. Scores range from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension), including an intermediate grade of 1+. Higher grades indicate greater resistance to passive movement.
Time frame: Baseline (T0) and immediately after the 4-week intervention (T1)
Presence of Neuropathic Pain Assessed by Routine Clinical Evaluation
Exploratory assessment of the presence or absence of neuropathic pain following stroke. Neuropathic pain will be assessed through routine clinical evaluation during inpatient rehabilitation. Patients are regularly questioned about the presence of pain and its characteristics, including symptoms suggestive of neuropathic pain. Based on this clinical assessment, neuropathic pain will be recorded as a binary variable (present or absent) at baseline and immediately after the intervention. No specific neuropathic pain questionnaire or diagnostic scale will be used.
Time frame: Baseline (T0) and immediately after the 4-week intervention (T1)
Stroke Impact Scale (SIS) Score
Exploratory assessment of patient-reported stroke impact using the Stroke Impact Scale (SIS), a multidimensional questionnaire evaluating physical function, cognition, communication, emotion, memory, participation, and perceived recovery. Domain scores are transformed to a 0-100 scale, with higher scores generally indicating better outcomes.
Time frame: Immediately after the 4-week intervention (T1)
Plan to share: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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