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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| contralateral 1Hz+ipsilateral iTBS 1 | Experimental | Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 1 |
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| contralateral 1Hz+ipsilateral iTBS 2 | Experimental | Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 2 |
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| contralateral 1Hz | Active Comparator | Patients received contralateral 1 Hz and ipsilateral sham iTBS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive transcranial magnetic stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment | Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome. | 12 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 week, 4 weeks, 12 weeks and 24 weeks post intervention |
| National Institutes of Health Stroke Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meng Ting Lin, M.D. | Contact | +886-2312-3456 | 67048 | b96401093@ntu.edu.tw |
| Ming Yen Hsiao, M.D., PhD | Contact | +886-2312-3456 | 67316 | myferrant@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Meng Ting Lin, M.D. | The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31901449 | Background | Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1. |
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will make further analysis
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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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. |
| 1 week, 4 weeks, 12 weeks and 24 weeks post intervention |
| Barthel Index | Barthel Index, score 100-0. Higher scores indicate a better outcome. | 1 week, 4 weeks, 12 weeks and 24 weeks post intervention |
| Modified Rankin Scale | Modified Rankin Scale, score from 0 to 6. Higher scores indicate a worse outcome. | 1 week, 4 weeks, 12 weeks and 24 weeks post intervention |
| MEP | motor evoked potential | 1 week, 4 weeks, 12 weeks and 24 weeks post intervention |
| Fugl-Meyer Assessment | Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome. | 1 week post intervention |
| Fugl-Meyer Assessment | Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome. | 4 weeks post intervention |
| Fugl-Meyer Assessment | Fugl-Meyer Assessment motor function set, score: 0-66, higher scores indicate a better outcome. | 24 weeks post intervention |