A Pilot Study of Repetitive Transcranial Magnetic Stimulation

NCT ID: NCT06482372

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2027-06-30

Brief Summary

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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

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Conditions

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Stroke Mirror Therapy Transcranial Magnetic Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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rTMS + mirror therapy + traditional OT

Patient would receive treatment three time per week, including individualized rTMS, and following mirror therapy and traditional occupational therapy.

Group Type EXPERIMENTAL

transcranial magnetic stimulation

Intervention Type DEVICE

repetitive transcranial magnetic stimulation at both cerebral hemisphere

rTMS + traditional OT

Patient would receive treatment three time per week, including individualized rTMS and following traditional occupational therapy.

Group Type ACTIVE_COMPARATOR

transcranial magnetic stimulation

Intervention Type DEVICE

repetitive transcranial magnetic stimulation at both cerebral hemisphere

sham rTMS + traditional OT

Patient would receive treatment three time per week, including sham rTMS and following traditional occupational therapy.

Group Type PLACEBO_COMPARATOR

transcranial magnetic stimulation

Intervention Type DEVICE

repetitive transcranial magnetic stimulation at both cerebral hemisphere

Interventions

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transcranial magnetic stimulation

repetitive transcranial magnetic stimulation at both cerebral hemisphere

Intervention Type DEVICE

Other Intervention Names

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mirror therapy

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cheng-Hsin General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jou Yu Lin

Role: CONTACT

+886-2-28264400 ext. 3806

Other Identifiers

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(1055)112A-46

Identifier Type: -

Identifier Source: org_study_id

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