Stroke
Conditions
Keywords
rTMS, stroke
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.
Interventions
OTHERrTMS-PTi
10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus immediate rehabilitation programs
OTHERrTMS-PTd
10 daily sessions of rTMS (1Hz, 1200 short, for totally 20 minutes) plus delayed rehabilitation programs (\>2hr)
OTHERrTMSs-PT
10 daily sessions of sham rTMS (to vertex) plus rehabilitation programs
Sponsors
National Taiwan University Hospital Hsin-Chu Branch
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>=20 years old, unilateral stroke diagnosed by CT or MRI 2. Post-stroke 1 week to 6 months 3. Medical Research Council Scale for Muscle Strength in upper limb ≤ 3 4. No history of previous stroke, seizure, dementia, parkinsonism or other neurodegenerative disease 5. stable medical condition and vital signs
Exclusion criteria
1. Previous stroke, traumatic brain injury, brain tumor 2. With central nervous system disease (spinal cord injury, Parkinson's disease) 3. Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker, Pregnancy...) 4. Patients unable to cooperate the treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment (FMA) | 12 weeks | Fugl-Meyer Assessment (FMA) of upper limb |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip strength | 12 weeks | Grip strength (Kg) |
| Barthel Index | 12 weeks | Barthel Index |
| Modified Rankin Scale | 12 weeks | Modified Rankin Scale |
| Medical Research Council (MRC) scale | 12 weeks | Medical Research Council (MRC) scale |
| motor evoked potential latency | 12 weeks | motor evoked potential latency of lesion site (ms) |
| 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) |
Countries
Taiwan
Contacts
Primary ContactSheng-Hao Cheng, MD
Backup ContactMeng Ting Lin, MD
Outcome results
None listed