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The Effect of Individualized fMRI-Guided rTMS on Upper Extremity Function for Patients with Post-Stroke Hemiplegia

The Effect of Individualized fMRI-Guided rTMS on Upper Extremity Function for Patients with Post-Stroke Hemiplegia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053454
Enrollment
Unknown
Registered
2021-11-21
Start date
2021-11-07
Completion date
Unknown
Last updated
2022-10-04

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

Conditions

Post-Stroke Hemiplegia

Interventions

Control group:Traditional hotspot target rTMS therapy
Intervention group:individualized rTMS therapy based on fMRI motor task activation points
Normal subjects:none

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Aged 20-75 years; 2. Stroke confirmed by imaging, the stroke focus is subcortical infarction located in the non-lateral motor area, and the type is hemiplegia with unilateral hemisphere injury; 3. The onset of the first stroke, with a course of more than 6 weeks 4. Brunnstrom classification (Brunnstrom, 1966) <= IV stage; 5. Agree to carry out rTMS treatment on the basis of conventional treatment, pass TMS safety screening, have no previous epilepsy and other neuropsychiatric diseases, and no other motor system diseases; 6. No contraindications for MRI scanning, no history of head trauma and severe heart disease; 7. Unconscious disturbance; 8. Can cooperate with the main test to complete the scale evaluation, MRI scan and TMS treatment; 9. Motor evoked potentials can be obtained in the contralateral hemisphere; 10. Able to complete hands-on tasks and obtain activation points in the lateral motor area of the unaffected hemisphere, and obtain the strongest functional connection between the lateral motor area of the affected hemisphere and the activation point of the unaffected hemisphere; 11. The head movement amplitude of all fMRI images is less than 2mm in translation and less than 2 degree in rotation; 12. Patients who voluntarily agree to join this study and sign the "informed consent form".

Exclusion criteria

Exclusion criteria: 1. Those who cannot tolerate the adverse reactions of transcranial magnetic stimulation, such as patients with metal implants in the body, VP shunts in the brain, arrhythmia, and a history of panic attacks; 2. Those with a pacemaker installed in the body; 3. Those who cannot cooperate; 4. Pregnant women.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment-Upper Extremities, FMA-UE;MRI;

Secondary

MeasureTime frame
Action Research Arm Test, ARAT;National Institute of Health Stroke scale, NIHSS;Barthel Index, BI;Study of Validity of Motor Status Scale;resting motor threshold;motor cortex excitability;

Countries

China

Contacts

Public ContactWu Yi

Department of Rehabilitation, Huashan Hospital, Fudan University

wuyi4000@163.com+86 21 52887820

Outcome results

None listed

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