Theta Burst Stimulation for Motor Recovery
ConditionTranscranial Magnetic Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
repetitive transcranial magnetic stimulation
DeviceRepetitive 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: contralateral 1Hz+ipsilateral iTBS 1Experimental treatment 1 intervention
Group B: contralateral 1Hz+ipsilateral iTBS 2Experimental treatment 1 intervention
Group C: contralateral 1HzActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fugl-Meyer Assessment
Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome.
Time frame
12 weeks post interventionSecondary outcomes
1
Medical Research Council (MRC) Scale for Muscle Strength
Medical Research Council (MRC) Scale for Muscle Strength, assessing muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).
Time frame
1 week, 4 weeks, 12 weeks and 24 weeks post intervention2
National Institutes of Health Stroke Scale
National Institutes of Health Stroke Scale, The maximum possible score is 42, with the minimum score being a 0. Higher scores indicate a worse outcome.
Time frame
1 week, 4 weeks, 12 weeks and 24 weeks post intervention3
Barthel Index
Barthel Index, score 100-0. Higher scores indicate a better outcome.
Time frame
1 week, 4 weeks, 12 weeks and 24 weeks post intervention4
Modified Rankin Scale
Modified Rankin Scale, score from 0 to 6. Higher scores indicate a worse outcome.
Time frame
1 week, 4 weeks, 12 weeks and 24 weeks post interventionSponsors and contacts
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Source ClinicalTrials.gov