Efficacy of Integrated Therapy of rTMS and rPMS on Upper Limb Function in Patients With Stroke

  • STATUS
    Recruiting
  • participants needed
    90
  • sponsor
    Chang Gung Memorial Hospital
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Updated on 16 February 2024
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transcranial magnetic stimulation
epilepsy
hemiplegia
brain lesion

Summary

Repetitive transcranial magnetic stimulation (rTMS) and repetitive peripheral magnetic stimulation (rPMS) are innovative treatments for patients with stroke. Therefore, the integrated therapy of rTMS and with repetitive peripheral magnetic stimulaiton (rPMS) is employed in this project. This proposal aims at exploring different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: rTMS integrated with rPMS.

Description

Several aims in this study include identifying a better protocol of rPMS with Theta burst stimulation (TBS) and different nerves stimulation location, identifying the most optimal treatment protocols for rPMS (TBS treatment and nerve stimulation location), integrating novel treatment protocol (optimal rTMS + rPMS), comparing efficacy between integrated therapy of optimal rTMS and rPMS treatment and single rTMS or rPMS treatment, determining the mechanism of neuro-motor control, clinical predictors, and related biomarkers for the novel treatment protocol A total of 108-135 patients with stroke will be recruited. During phase 1 (year 1 and year 2), 72 to 90 participants will be randomly enrolled in different groups (12-15 participants in each group). For the first year, the participants will be randomly enrolled in 3 different groups according to the TBS mode (iTBS vs.cTBS). In the second year, the participants will be randomly enrolled in 3 different groups according to the stimulated nerves (radial, median/ulnar nerves) to find the optimal novel treatment protocols for UE dysfunction in patients with stroke. During phase 2 (2-3 years), 36 to 45 patients will be randomly enrolled into 3 groups of rTMS and rPMS integrated therapy to identify optimal integrated novel treatment protocol.

Outcome measures include clinical based on International Classification of Functioning, Disability and Health (ICF) and motor control (Motor Evoked Potential, MEP; muscle tone assessment (MYOTON); pinch and grip strength and kinematics of upper extremity) assessments that administered at pretest, posttest, and 3-month follow-up. The aim of this study is to establish the novel assessment and treatment protocols in patients with stroke. The intervention will be conducted 10 times in 2 weeks (five times per week). The optimal effective treatment protocol of combination of rTMS and rPMS will also be established. The results of this study will be applied to the translational and evidence-based medicine of the neuro-rehabilitation field of stroke research.

Details
Condition Cerebrovascular accident
Age 20years - 80years
Treatment rTMS+rPMS_iTBS_R, rTMS+rPMS_cTBS_R, rTMS +sham-rPMS, rTMS+rPMS_iTBS_M/U, rTMS+rPMS_cTBS_M/U, sham-rTMS+sham-rPMS, rTMS + optimal-rPMS, sham-rTMS+optimal-rPMS
Clinical Study IdentifierNCT04265365
SponsorChang Gung Memorial Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

first stoke and in stable phase
age 20-80 years
unilateral brain lesions with unilateral hemiplegia
brain wave examination without epileptic waves

Exclusion Criteria

brain stem or cerebellar stroke
Patients with epilepsy
Patients with aneurysm or cerebrovascular malformation
Patients with mental illness
Patients with degenerative diseases (such as neurodegenerative diseases)
Patients with severe intelligence or language barriers (such as mental retardation or severe communication impairment)
Patients with serious medical conditions (such as heart failure)
Patients with acute disease (such as infection)
Patients had metal implants in the body (such as cardiac rhythm or brain metal implants, metal clips for aneurysms)
Patients had botox injection or surgery in the first half of the study
pregnant woman or breastfeeding woman
other obstacles (such as claustrophobia, obesity, etc.)
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