Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To compare the effects of various combinations between 6 hertz(Hz) rTMS & LFrTMS on the limb motor dysfunction due to cerebral vascular disease.
It is the basic principle for functional recovery after cerebrovascular disease to restore the original balance in reciprocal inhibition between affected hemisphere and unaffected hemisphere.
repetitive transcranial magnetic stimulation (rTMS) is a noninvasive neuroplastic technique rebalancing interhemispheric competition after stroke. Low frequency rTMS (LFrTMS) on contralesional hemisphere or high frequency rTMS (HFrTMS) on lesional hemisphere might be the basic choice.
6 hertz(Hz) primed LFrTMS on lesional primary motor cortex has the stronger effect than LFrTMS alone does on one hand; the other newly-developed combination, i.e. HFrTMS on lesional primary motor cortex and LFrTMS on contralesional primary motor cortex might also be more effective than they do respectively on the other hand.
The main aim of our research is to find out which combination is better by considering both safety and efficiency.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combined rTMS at both M1 | Experimental | combined rTMS at both M1: sham 6 hertz(Hz) rTMS on unaffected M1 / real 1 Hz rTMS on unaffected M1 / real 6 Hz rTMS on affected M1 |
|
| real primed LFrTMS at unaffected M1 | Experimental | real primed LFrTMS at unaffected M1: real 6 hertz(Hz) rTMS on unaffected M1 / real 1 Hz rTMS on unaffected M1 / sham 6 Hz rTMS on affected M1 |
|
| real LFrTMS at unaffected M1 | Active Comparator | real LFrTMS at unaffected M1: sham 6 hertz(Hz) rTMS on unaffected M1 / real 1 Hz rTMS on unaffected M1 / sham 6 Hz rTMS on affected M1 |
|
| all sham stimulation | Sham Comparator | all sham stimulation: sham 6 hertz(Hz) rTMS on unaffected M1 / sham 1 Hz rTMS on unaffected M1 /sham 6 Hz rTMS on affected M1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| real LFrTMS at unaffected M1 | Device | Compare the effect of LFrTMS at unaffected M1 to that of all sham stimulation on motor rehabilitation after cerebrovascular disease . rTMS: Repetitive Transcranial Magnetic Stimulation. Combination Elements: ①6 hertz(Hz) rTMS at unaffected M1 before LFrTMS at unaffected M1 ;②6 Hz rTMS at affected M1;③1 Hz rTMS at unaffected M1. The four groups are the combinations of real or sham ①/②/③. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer assessment (FMA) | Score of Fugl-Meyer assessment | 1) Before treatment (Baseline); 2) Change from Baseline FMA at the 1st workday after the last treatment; 3) Change from Baseline FMA at the 28th natural day after the last treatment |
| Simple Test for Evaluating Hand Function (STEF) | Score of Simple Test for Evaluating Hand Function | 1) Before treatment (Baseline); 2) Change from Baseline STEF at the 1st workday after the last treatment; 3) Change from Baseline STEF at the 28th natural day after the last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| National Institute of Health Stroke Scale (NIHSS) | Score of National Institute of Health Stroke Scale | 1) Before treatment (Baseline); 2) Change from Baseline NIHSS at the 1st workday after the last treatment; 3) Change from Baseline NIHSS at the 28th natural day after the last treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Xing, M.D. | Contact | +86-13521278542 | zhuanglixingjin@163.com | |
| Xinxin Ma, M.D | Contact | +86-15901043667 | zhuanglixingjin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Zhuang, M.D. | Beijing Hospital, National Center of Gerontology, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital, National Center of Gerontology | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23532011 | Background | Sung WH, Wang CP, Chou CL, Chen YC, Chang YC, Tsai PY. Efficacy of coupling inhibitory and facilitatory repetitive transcranial magnetic stimulation to enhance motor recovery in hemiplegic stroke patients. Stroke. 2013 May;44(5):1375-82. doi: 10.1161/STROKEAHA.111.000522. Epub 2013 Mar 26. | |
| 24422912 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| real primed LFrTMS at unaffected M1 | Device | Compare the effect of primed LFrTMS at unaffected M1 to that of LFrTMS at unaffected M1 on motor rehabilitation after cerebrovascular disease . rTMS: Repetitive Transcranial Magnetic Stimulation. Combination Elements: ①6 hertz(Hz) rTMS at unaffected M1 before LFrTMS at unaffected M1 ;②6 Hz rTMS at affected M1;③1 Hz rTMS at unaffected M1. The four groups are the combinations of real or sham ①/②/③. |
|
| combined rTMS at both M1 | Device | Compare the effect of combined rTMS at both M1 to that of primed LFrTMS at unaffected M1 on motor rehabilitation after cerebrovascular disease . rTMS: Repetitive Transcranial Magnetic Stimulation. Combination Elements: ①6 hertz(Hz) rTMS at unaffected M1 before LFrTMS at unaffected M1 ;②6 Hz rTMS at affected M1;③1 Hz rTMS at unaffected M1. The four groups are the combinations of real or sham ①/②/③. |
|
| all sham stimulation | Device | used as controls to eliminate the placebo effect of all kinds of combinated rTMS |
|
| Wang CP, Tsai PY, Yang TF, Yang KY, Wang CC. Differential effect of conditioning sequences in coupling inhibitory/facilitatory repetitive transcranial magnetic stimulation for poststroke motor recovery. CNS Neurosci Ther. 2014 Apr;20(4):355-63. doi: 10.1111/cns.12221. Epub 2014 Jan 15. |
| 20026185 | Background | Carey JR, Anderson DC, Gillick BT, Whitford M, Pascual-Leone A. 6-Hz primed low-frequency rTMS to contralesional M1 in two cases with middle cerebral artery stroke. Neurosci Lett. 2010 Jan 29;469(3):338-42. doi: 10.1016/j.neulet.2009.12.023. Epub 2009 Dec 18. |
| 26198365 | Background | Cassidy JM, Chu H, Anderson DC, Krach LE, Snow L, Kimberley TJ, Carey JR. A Comparison of Primed Low-frequency Repetitive Transcranial Magnetic Stimulation Treatments in Chronic Stroke. Brain Stimul. 2015 Nov-Dec;8(6):1074-84. doi: 10.1016/j.brs.2015.06.007. Epub 2015 Jun 22. |
| 17876070 | Background | Carey JR, Evans CD, Anderson DC, Bhatt E, Nagpal A, Kimberley TJ, Pascual-Leone A. Safety of 6-Hz primed low-frequency rTMS in stroke. Neurorehabil Neural Repair. 2008 Mar-Apr;22(2):185-92. doi: 10.1177/1545968307305458. Epub 2007 Sep 17. |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided