Repetitive Transcranial Magnetic Stimulation Combined With Bimanual Therapy for Upper Limb Stroke Rehabilitation

Chang Gung Medical Foundation

Status: Not yet enrolling

Conditions: Repetitive Transcranial Magnetic Stimulation (rTMS); Bimanual Therapy; Post-stroke Upper Limb Hemiparesis; Neuromodulation

Treatments: Other: stretching exercise; Other: rTMS; Other: Conventional occupation therapy; Device: bimanual therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07054424

202400379A0C6001

Details and patient eligibility

About

The goal of this clinical trial is to evaluate whether combining repetitive transcranial magnetic stimulation (rTMS) with machine-assisted bimanual therapy (BT) can improve upper limb function in stroke patients. The participants will be individuals aged 40-80 years who have experienced a first-time ischemic or hemorrhagic stroke. The main questions it aims to answer are:

• Does the combined therapy enhance motor recovery compared to traditional rehabilitation methods?
• Are changes in brain activity associated with improvements in upper limb function?

Participants will be randomly assigned to different groups and will:

• Receive rTMS stimulation on specific areas of the brain to modulate neural activity,
• Perform machine-assisted bimanual exercises to promote motor skills, and
• Undergo assessments before, immediately after, and during follow-up periods to measure functional improvements.

Enrollment: 54 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 3 patient groups

Control group

Sham Comparator group

Description:

15 mins self-initiated stretching exercise + 50 mins conventional occupational therapy

Treatment:

Other: Conventional occupation therapy

Other: stretching exercise

rTMS-only group

Active Comparator group

Description:

15 mins rTMS and 50 mins conventional occupational therapy

Treatment:

Other: Conventional occupation therapy

Other: rTMS

rTMS combined with bimanual therapy group

Experimental group

Description:

15 mins therapy (rTMS + bimanual therapy) and 50 mins conventional occupational therapy

Treatment:

Device: bimanual therapy

Other: Conventional occupation therapy

Other: rTMS