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To accelerate iTBS to improve the motor function of moderate to severe upper limb hemiplegia by regulating the contralateral M1 region and its mechanism

To accelerate iTBS to improve the motor function of moderate to severe upper limb hemiplegia by regulating the contralateral M1 region and its mechanism

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113685
Enrollment
Unknown
Registered
2025-12-02
Start date
2025-12-02
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

stroke

Interventions

Group 1: iTBS(600 pulses +1200 sham stimulation)
Group 3:iTBS (1800 pulses)
Group 4:false iTBS(1800 sham stimulation)
Group 2: iTBS(1200 pulses +600 sham stimulation)

Sponsors

Shanghai Second Rehabilitation Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis met the diagnostic criteria of "Key points for the Diagnosis of Major cerebrovascular Diseases in China 2019" and was confirmed by head CT or MRI; 2. First occurrence of unilateral cerebral hemisphere cerebral infarction/cerebral hemorrhage, patients with cerebral hemorrhage had not undergone head surgery; 3. Age of 55-85 years old; 4. The course of disease was 3-12 months; 5. There is moderate to severe motor dysfunction, the proximal part of the hemiplegic side FMA-UE score is less than 26 points, and the conventional neuromodulation effect is not good; 6. Patients or their immediate family members understood and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with unstable condition and unstable vital signs; 2. Patients who could not tolerate iTBS treatment; 3. Patients with previous Parkinson's disease, peripheral neuropathy and other motor dysfunction; 4. Combined with tumor, serious diseases of respiratory, cardiac, hepatic, renal, endocrine and hematopoietic systems; 5. Pregnant and lactating women; 6. Patients with a history of epilepsy or family history of epilepsy, metal pacemakers, metal implants in the brain, cochlear implants, and skull defects who are not suitable for transcranial magnetic stimulation; 7. Patients who were enrolled in other clinical trials or had recently received neuromodulation therapy.

Design outcomes

Primary

MeasureTime frame
Functional Near Infrared (fNIRS) Detection;

Secondary

MeasureTime frame
Fugl-Meyer Assessment-Upper Extremity;modified Ashworth Scale, MAS;modified Barthel Index,MBI;

Countries

China

Contacts

Public ContactCheng Xie

Shanghai Second Rehabilitation Hospital

xieencheng1993@126.com+86 21 6618 1108

Outcome results

None listed

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