Comparative Efficacy of Different Doses of Theta Burst Stimulation for Motor Recovery in Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer Assessment
Study Overview
Brief Summary
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.
Detailed Description
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. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect. Through modulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients.
This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1.Unilateral ischemic or hemorrhagic stroke
- •2.Stroke within 3 months
- •3.Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
- •4.No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
- •5.Patient could sit over 15 minutes
- •6.Age over 20
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)
- •4.Patients unable to cooperate the treatment
- •5.Pregnancy
- •6.Depression
Arms & Interventions
contralateral 1Hz+ipsilateral iTBS 1
Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 1
Intervention: repetitive transcranial magnetic stimulation (Device)
contralateral 1Hz+ipsilateral iTBS 2
Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 2
Intervention: repetitive transcranial magnetic stimulation (Device)
contralateral 1Hz
Patients received contralateral 1 Hz and ipsilateral sham iTBS
Intervention: repetitive transcranial magnetic stimulation (Device)
Outcomes
Primary Outcomes
Fugl-Meyer Assessment
Time Frame: 12 weeks post intervention
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
Secondary Outcomes
- Barthel Index(1 week, 4 weeks, 12 weeks and 24 weeks post intervention)
- Medical Research Council (MRC) Scale for Muscle Strength(1 week, 4 weeks, 12 weeks and 24 weeks post intervention)
- Modified Rankin Scale(1 week, 4 weeks, 12 weeks and 24 weeks post intervention)
- National Institutes of Health Stroke Scale(1 week, 4 weeks, 12 weeks and 24 weeks post intervention)
- MEP(1 week, 4 weeks, 12 weeks and 24 weeks post intervention)
- Fugl-Meyer Assessment(24 weeks post intervention)
- Fugl-Meyer Assessment(1 week post intervention)
- Fugl-Meyer Assessment(4 weeks post intervention)