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Efficacy and mechanism of a brain-computer interface hand rehabilitation robot combined with transcranial magnetic stimulation for the treatment of post-stroke hand dysfunction based on DTI technology

Efficacy and mechanism of a brain-computer interface hand rehabilitation robot combined with transcranial magnetic stimulation for the treatment of post-stroke hand dysfunction based on DTI technology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103478
Enrollment
Unknown
Registered
2025-05-29
Start date
2021-12-12
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Stroke

Interventions

BCI group:BCI training add-on to standard therapy
BCI+rTMS group:Sequential rTMS followed by BCI training add-on to standard therapy
Conventional rehabilitation group:Conventional rehabilitation therapy alone

Sponsors

Longgang District People's Hospital, Shenzhen, Guangdong, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age: 18 to 80 years old. (2) Diagnosis: Stroke confirmed by the diagnostic criteria established at the 4th National Cerebrovascular Disease Academic Conference (1995, China). (3) Disease Status: First-onset unilateral hemiplegia, with a disease course of 2 weeks to 6 months post-stroke. (4) Hand Dysfunction: Moderate-to-severe hand dysfunction (Brunnstrom stage <=4, MAS score <=3). (5) Cognitive Function: No severe cognitive impairment; ability to follow instructions and perform hand movements (e.g., grasping). (6) Medical History: - No severe hepatic/renal dysfunction, traumatic brain injury, drug/alcohol dependence, or other conditions that may affect brain structure/function. - No comorbid psychiatric disorders. (7) Physical Ability: Ability to sit independently or with support for =1 hour. (8) Consent: Voluntarily participation with signed informed consent.

Exclusion criteria

Exclusion criteria: (1) History of two or more strokes (recurrent stroke). (2) Pre-existing limb dysfunction due to other causes (e.g., trauma, neuropathy) prior to the current stroke. (3) Severe cardiac, pulmonary, or renal complications. (4) Other neurological disorders, inability to cooperate with training, or poor treatment compliance. (5) Cognitive impairment (MMSE <21), visual or hearing deficits. (6) Sensory aphasia or mixed aphasia. (7) Unstable fractures, infections, or active bleeding in the affected hand.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment (FMA) - Hand/Wrist Subscale;Action Research Arm Test, ARAT;Wolf Motor Function Test, WMFT;

Secondary

MeasureTime frame
ADL;DTI;

Countries

China

Contacts

Public ContactWang Benguo

Longgang District People's Hospital, Shenzhen, Guangdong, China

18760350279@163.com+86 135 2826 5815

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026