A multicenter randomized controlled study of the effects of different excitability intervention protocols in bilateral M1 hand regions of the brain on motor recovery after spinal cord injury

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400094593

Enrollment

Unknown

Registered

2024-12-25

Start date

2025-01-01

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

spinal cord injury

Interventions

Group A:10 Hz rTMS on dominant side + 1 Hz rTMS on non-dominant side

Group B:10Hz rTMS on dominant side + sham rTMS on non-dominant side

Group C:10 Hz rTMS on dominant side + 10 Hz rTMS on non-dominant side

Group D:sham rTMS + non-dominant side sham rTMS

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. age 18-70 years, right-handed (Edinburgh Sharp Handedness Questionnaire); 2. patients with established SCI; 3. duration of illness after injury: less than 6 months; 4. patients not undergoing any form of rTMS treatment within 2 weeks; 5. no cognitive impairment with a score of >=24 on the Brief Mental State Examination (MMSE); 6. informed consent signed by the patient or immediate family.

Exclusion criteria

Exclusion criteria: 1. severe neurological disease that cannot tolerate the test; 2. lower limb fracture, arteriovenous fistula or other diseases that cause lower limb mobility impairment; 3. ferromagnetic implants in the head or neck; 4. implanted cardiac pacemakers; 5. severe coagulation disorders, severe cardiac insufficiency, or uncontrollable high blood pressure: systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg; 6. other serious Systemic diseases such as tumors; 7. Patients who have taken medications that affect spTMS testing such as baclofen and diazepam within 1 week.

Design outcomes

Primary

Measure	Time frame
Manual MuscleTest;	—

Secondary

Measure	Time frame
modified Ashworth scale;10 Metre Walk Test;spinal cord lesion independence measure;Modified Barthel score;Short-formMcGill Pain Questionnaire-2;numerical rating scale;Douleur Neuropathique 4 questions;Location and extent of pain;Generalized Anxiety Disorder-7;Patient Health Questionnaire-9;Single-pulse Transcranial Magnetic Stimulation;	—

Countries

China

Contacts

Public ContactYuan Hua

The First Affiliated Hospital of Air Force Medical University

445034571@qq.com+86 29 8477 5439

Outcome results

None listed

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