rTMS with machine-assisted bimanual therapy for improving arm function after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares a combined neuromodulation and therapy approach to standard rehabilitation for post-stroke upper limb weakness. Participants aged 40–80 with a first-time ischemic or hemorrhagic stroke within the past year will be randomly assigned to receive rTMS to targeted brain areas and machine-assisted bimanual exercises, along with conventional therapy. Assessments are conducted before, immediately after, and during follow-up to evaluate motor function and brain activity changes. The study aims to determine if the combined therapy yields greater motor recovery and how neural changes relate to functional gains. Lead sponsor is Chang Gung Memorial Hospital in Taiwan, with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 40-80 years;
2. First-onset stroke patients;
3. Patients diagnosed with cerebral infarction or hemorrhage through CT or MRI;
4. Signed informed consent form by the patient and their family;
5. Stable physiological parameters;
6. Stroke occurred within the last 12 months;
7. Patients with unilateral hand function impairment caused by the stroke;
8. Upper limb muscle tone (Modified Ashworth Scale, MAS) less than 3 points;
9. Able to follow two-step commands.

Exclusion Criteria:

1. A history of epilepsy or family history of epilepsy;
2. Presence of suicidal tendencies;
3. Currently using medications that lower the seizure threshold;
4. Pregnant or planning to become pregnant;
5. Co-existing neurological diseases (such as multiple sclerosis, other neurodegenerative diseases, meningitis, brain abscess, or meningioma);
6. Subjects with uncontrollable migraines caused by elevated intracranial pressure;
7. Subjects taking antidepressants who cannot discontinue the medication;
8. Subjects with sleep disorders during rTMS treatment;
9. Subjects with cerebellar stroke or brainstem stroke;
10. Cerebral ischemic disorders resulting from traumatic brain injury;
11. Transient ischemic attacks (TIAs);
12. History of bleeding tendency and other conditions affecting upper limb function, such as myasthenia gravis, systemic immune neuropathy, severe epilepsy, endocrine system disorders, wearers of external or internal cardiac pacemakers, individuals with metallic implants or orthopedic devices;
13. Co-existing severe heart, liver, kidney dysfunction, or other serious physical illnesses;
14. Subjects with impaired consciousness who cannot cooperate with examinations or treatments, such as those with mental disorders, or those with intellectual or cognitive impairments, severe dementia;
15. Presence of implanted electronic devices in the body;
16. Co-existing severe liver, kidney, or hematological disorders;
17. Special vulnerable populations;
18. Skin disease (e.g., pressure ulcers, trauma, cellulitis, etc.).

Where it's running

• Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Linkou, Taoyuan 333, Taiwan
  Taoyuan, Taiwan Recruiting

Study contacts

• Study coordinator: Yu-Cheng Pei, MD, PhD
• Email: yspeii@gmail.com
• Phone: +886 3 3281200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.