A Pilot Study of Repetitive Transcranial Magnetic Stimulation

NCT06482372 | Not Yet Recruiting

• 1 other identifier: (1055)112A-46
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Mirror Therapy; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (5)

• Fugl-Meyer Assessment (FMA) - upper extremity

  FMA would be recorded for evaluate patients' motor function of hand.

  week 0, week 6, week 12

• Nine-hole peg test

  Nine-hole peg test would be used to measure finger dexterity.

  week 0, week 6, week 12

• Action research arm test

  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

  Box and block test would be used to assess unilateral gross manual dexterity.

  week 0, week 6, week 12

• Functional independence measurement

  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

Study Arms (3)

rTMS + mirror therapy + traditional OT

EXPERIMENTAL

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

Device: transcranial magnetic stimulation

rTMS + traditional OT

ACTIVE COMPARATOR

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

Device: transcranial magnetic stimulation

sham rTMS + traditional OT

PLACEBO COMPARATOR

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

Device: transcranial magnetic stimulation

Interventions

transcranial magnetic stimulation DEVICE

repetitive transcranial magnetic stimulation at both cerebral hemisphere

Also known as: mirror therapy

rTMS + mirror therapy + traditional OT; rTMS + traditional OT; sham rTMS + traditional OT

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cheng-Hsin General Hospital: lead

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Magnetic Stimulation; Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Jou Yu Lin

CONTACT

+886-2-28264400; trancequid@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: July 1, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 1, 2024

Record last verified: 2024-06