A Pilot Study of Repetitive Transcranial Magnetic Stimulation

June 28, 2024 updated by: Cheng-Hsin General Hospital

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Device: transcranial magnetic stimulation
repetitive transcranial magnetic stimulation at both cerebral hemisphere
Other Names:
  • mirror therapy
Active Comparator: rTMS + traditional OT
Patient would receive treatment three time per week, including individualized rTMS and following traditional occupational therapy.
Device: transcranial magnetic stimulation
repetitive transcranial magnetic stimulation at both cerebral hemisphere
Other Names:
  • mirror therapy
Placebo Comparator: sham rTMS + traditional OT
Patient would receive treatment three time per week, including sham rTMS and following traditional occupational therapy.
Device: transcranial magnetic stimulation
repetitive transcranial magnetic stimulation at both cerebral hemisphere
Other Names:
  • mirror therapy

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

This is where you will find people and organizations involved with this study.

Sponsor

Cheng-Hsin General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

March 17, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 1, 2024

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on transcranial magnetic stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe