A Pilot Study of Repetitive Transcranial Magnetic Stimulation

Not Applicable

Not yet recruiting

• Conditions: Stroke; Mirror Therapy; Transcranial Magnetic Stimulation
• Interventions: Device: transcranial magnetic stimulation

• Registration Number: NCT06482372
• Lead Sponsor: Cheng-Hsin General Hospital

Brief Summary

Stroke patients often have long-term upper limb dysfunction. Currently, there is still no specific clinical treatment for nerve damage. After acute treatments of stroke, patients' motor ability can only improve by spontaneous recovery of brain and rehabilitation treatment.

Transcranial magnetic stimulation uses a magnetic field pulse generated by a coil outside the skull to pass through the skull. It uses the principle that magnetic electricity can generate currents, which activates nearby brain areas or changing the relationship between the left and right brains. Transcranial magnetic stimulation is a non-invasive, safe treatment.

Mirror therapy is an emerging rehabilitation method in recent years. As mirror therapy, therapists ask the patient to place the affected hand behind the mirror while looking at the image reflected by the unaffected upper limb. During mirror therapy, patients have to perform upper limb activities and imagine that the affected upper limb is performing the same action.

As mentioned above, transcranial magnetic stimulation and mirror therapy improve the recovery of stroke patients by two different ways. Currently, there are no studies that combine these two treatments. Therefore, our study hopes to initially explore the efficacy of transcranial magnetic stimulation and the efficacy of transcranial magnetic stimulation combined with mirror therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-17
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-28
• Last Update Submitted: 2024-06-28
• Study First Posted: 2024-07-01
• Last Update Posted: 2024-07-01
• Study Start: 2024-10-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• at least 1 month after stroke
• manual muscle strength < 5

Exclusion Criteria

• history of epilepsy
• has other central nervous system diseases
• has electric medication pump
• has implant at inner ear

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS + mirror therapy + traditional OT	transcranial magnetic stimulation	Patient would receive treatment three time per week, including individualized rTMS, and following mirror therapy and traditional occupational therapy.
sham rTMS + traditional OT	transcranial magnetic stimulation	Patient would receive treatment three time per week, including sham rTMS and following traditional occupational therapy.
rTMS + traditional OT	transcranial magnetic stimulation	Patient would receive treatment three time per week, including individualized rTMS and following traditional occupational therapy.

Primary Outcome Measures

Name	Time	Method
Nine-hole peg test	week 0, week 6, week 12	Nine-hole peg test would be used to measure finger dexterity.
Fugl-Meyer Assessment (FMA) - upper extremity	week 0, week 6, week 12	FMA would be recorded for evaluate patients' motor function of hand.
Action research arm test	week 0, week 6, week 12	Action research arm test would be used to assess upper extremity performance including coordination, dexterity and functioning.
Box and block test	week 0, week 6, week 12	Box and block test would be used to assess unilateral gross manual dexterity.
Functional independence measurement	week 0, week 6, week 12	Functional independence measurement would be recorded to assess a patient's level of disability as well as a change in patient status in response to rehabilitation or medical intervention.