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A Clinical Study of Brain–Computer Interface–Based Transcutaneous Acupoint Electrical Stimulation for Post-Stroke Upper Limb Motor Dysfunction

Mechanisms and Efficacy Evaluation of Brain-Computer Interface-Guided Transcutaneous Electrical Acupoint Stimulation for Post-Stroke Upper Limb Motor Dysfunction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000990
Enrollment
Unknown
Registered
2026-04-16
Start date
2026-04-08
Completion date
Unknown
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Interventions

Control Group:Simulated Brain–Computer Interface–Based Transcutaneous Acupoint Electrical Stimulation
Experimental Group:Brain–Computer Interface–Based Transcutaneous Acupoint Electrical Stimulation

Sponsors

Shanghai Second Rehabilitation Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 1) Time since onset = 6 months, with stable medical condition; 2. 2) Diagnosis of stroke confirmed by cranial CT or MRI, in accordance with the *Diagnostic Criteria for Major Cerebrovascular Diseases in China (2019)*; 3. 3) Age 18–75 years (inclusive of 18 and 75 years); 4. 4) Upper limb motor function score = 10 on the Fugl-Meyer Assessment Upper Limb subscale (FMA-UL); 5. 5) Upper limb muscle tone graded = 1+ on the Modified Ashworth Scale (MAS); 6. 6) Adequate cognitive function without significant attention deficits, with a Mini-Mental State Examination (MMSE) score = 22; 7. 7) Stable vital signs and medical condition, able to tolerate low-intensity seated balance training; 8. 8) Voluntary participation and provision of written informed consent.

Exclusion criteria

Exclusion criteria: 1. 1) Patients currently receiving other non-invasive brain stimulation interventions, such as Transcranial Magnetic Stimulation (TMS) or transcranial Direct-Current Stimulation (tDCS); 2. 2) Presence of clinically significant unilateral neglect; 3. 3) Poor treatment compliance; 4. 4) Concomitant severe internal medical conditions (e.g., heart failure, respiratory failure, renal insufficiency, uncontrolled hypertension, cardiac arrhythmia, severe coronary heart disease, or poorly controlled diabetes-related complications); 5. 5) Presence of any acute or chronic infections (e.g., pulmonary tuberculosis, intracranial infection, etc.); 6. 6) Pregnancy; 7. 7) Concurrent participation in other clinical trials; 8. 8) Presence of metallic foreign bodies or implanted electronic devices in the head or neck region.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment for Upper Extremity (FMA-UE) ;—

Secondary

MeasureTime frame
Action Research Arm Test (ARAT);Modified Ashworth Scale (MAS);Modified Barthel Index (MBI);Manual Muscle Testing (MMT);Brunnstrom Stages;Functional Near-Infrared Spectroscopy Signal ;electroencephalogram signal;—

Countries

China

Contacts

Public ContactFengjiao Liang

Shanghai University of Traditional Chinese Medicine

liangfengjiao98125@126.com18340078102

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026