Comparative Efficacy of Different Time Interval Between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients
- Conditions
- Stroke
- Interventions
- Other: rTMS-PTiOther: rTMS-PTdOther: rTMSs-PT
- Registration Number
- NCT05663424
- Lead Sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Brief Summary
Comparative Efficacy of Different Time Interval between rTMS and Rehabilitation Program for Motor Recovery in Stroke Patients
- Detailed Description
Stroke is one of the main causes of death and disability in Taiwan. The M1 excitability of the affected hemisphere decreases, while that of the unaffected hemisphere increases, leading to further interhemispheric inhibition. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Through regulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients. Previous study had been demonstrated that priming rehabilitation program with low frequent rTMS would lead to better motor recovery in the chronic stroke patients. However, the optimal time interval between the rTMS and the rehabilitation program had not been investigated. Thus, this study will utilize low frequent rTMS, targeting the intact hemisphere, to investigate the clinical effects and motor cortex excitability under different time intervals between the rTMS and the rehabilitation program.
This study is designed as a randomized controlled trial. We plan to recruit 45 subacute stroke patients with hemiplegia. The patients are randomly assigned to three groups. In the Group 1, the patients receive contralateral 1 Hz rTMS stimulation and subsequent rehabilitation program. In the Group 2, the patients receive contralateral 1 Hz rTMS, but the rehabilitation will be delayed at least two hours after the rTMS stimulation. The control group receive sham rTMS and subsequent rehabilitation program. The treatment schedule for all groups will be five times per week for a two-week course, which means a total of ten sessions. The primary outcome is upper limb Fugl-Meyer Assessment. The secondary outcomes included Medical Research Council (MRC) scale, Barthel Scale, Modified Rankin Scale (MRS), cortical excitability assessment (including bilateral maximum MEP amplitude, MEP latency, and bilateral resting motor threshold). Follow-up time points are before rTMS and at 1st, 4th, 12th weeks after the end of the treatments.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description immediate rehabilitation group rTMS-PTi rTMS plus immediate rehabilitation programs delayed rehabilitation group rTMS-PTd rTMS plus delayed rehabilitation programs sham rTMS group rTMSs-PT sham rTMS + rehabilitation programs
- Primary Outcome Measures
Name Time Method Fugl-Meyer Assessment (FMA) 12 weeks Fugl-Meyer Assessment (FMA) of upper limb
- Secondary Outcome Measures
Name Time Method Modified Rankin Scale 12 weeks Modified Rankin Scale
motor evoked potential latency 12 weeks motor evoked potential latency of lesion site (ms)
Barthel Index 12 weeks Barthel Index
Medical Research Council (MRC) scale 12 weeks Medical Research Council (MRC) scale
Grip strength 12 weeks Grip strength (Kg)
resting motor threshold 12 weeks bilateral resting motor threshold (mV)
maximal motor evoked potential amplitude 12 weeks maximal motor evoked potential amplitude of lesion site (mV)
Trial Locations
- Locations (1)
National Taiwan University Hospital Hsin-Chu Branch
🇨🇳Hsinchu, Taiwan