A Pilot Study of Repetitive Transcranial Magnetic Stimulation
Effects of Repetitive Transcranial Magnetic Stimulation Combined With Mirror Therapy on Upper Limb Function in Patients With Stroke: a Pilot Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jou Yu Lin
- Phone Number: 3806 +886-2-28264400
- Email: trancequid@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: rTMS + mirror therapy + traditional OT
Patient would receive treatment three time per week, including individualized rTMS, and following mirror therapy and traditional occupational therapy.
|
repetitive transcranial magnetic stimulation at both cerebral hemisphere
Other Names:
|
|
Active Comparator: rTMS + traditional OT
Patient would receive treatment three time per week, including individualized rTMS and following traditional occupational therapy.
|
repetitive transcranial magnetic stimulation at both cerebral hemisphere
Other Names:
|
|
Placebo Comparator: sham rTMS + traditional OT
Patient would receive treatment three time per week, including sham rTMS and following traditional occupational therapy.
|
repetitive transcranial magnetic stimulation at both cerebral hemisphere
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Assessment (FMA) - upper extremity
Time Frame: week 0, week 6, week 12
|
FMA would be recorded for evaluate patients' motor function of hand.
|
week 0, week 6, week 12
|
|
Nine-hole peg test
Time Frame: week 0, week 6, week 12
|
Nine-hole peg test would be used to measure finger dexterity.
|
week 0, week 6, week 12
|
|
Action research arm test
Time Frame: week 0, week 6, week 12
|
Action research arm test would be used to assess upper extremity performance including coordination, dexterity and functioning.
|
week 0, week 6, week 12
|
|
Box and block test
Time Frame: week 0, week 6, week 12
|
Box and block test would be used to assess unilateral gross manual dexterity.
|
week 0, week 6, week 12
|
|
Functional independence measurement
Time Frame: 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.
|
week 0, week 6, week 12
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- (1055)112A-46
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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