Comparing Effects of Various Combinations of 6 Hertz(Hz) rTMS & LFrTMS on Motor Recovery Due to Cerebrovascular Disease
NCT ID: NCT03012204
Last Updated: 2017-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2017-02-16
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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combined rTMS at both M1
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
combined rTMS at both M1
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.
real primed LFrTMS at unaffected M1
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 primed LFrTMS at unaffected M1
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.
real LFrTMS at unaffected M1
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
real LFrTMS at unaffected M1
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.
all sham stimulation
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
all sham stimulation
used as controls to eliminate the placebo effect of all kinds of combinated rTMS
Interventions
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real LFrTMS at unaffected M1
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.
real primed LFrTMS at unaffected M1
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
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
used as controls to eliminate the placebo effect of all kinds of combinated rTMS
Eligibility Criteria
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Inclusion Criteria
* Newly onset cerebral infarction or brain hemorrhage confirmed by MRI or CT;
* the disease duration is less than 20 weeks when recruited into the trial;
* no existence of limb motor dysfunction before this onset, and new occurrence of unilateral limb motor dysfunction after this onset;
* the physical and mental condition are good enough to cooperate with the assessment and treatment;
* the NIHSS score: total 5-20,1a,1b,1c=0;
* the subject or legal guardian sign the consent form.
Exclusion Criteria
* with skull defect;
* with metal implants, cardiac pacemaker, cochlear implantation;
* epileptiform discharge in EEG.
30 Years
90 Years
ALL
No
Sponsors
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Beijing Hospital
OTHER_GOV
Responsible Party
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ZHUANG Li, MD
Chief Physician
Principal Investigators
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Li Zhuang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Hospital, National Center of Gerontology, China
Locations
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Beijing Hospital, National Center of Gerontology
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xin Wang
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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121-2016010
Identifier Type: -
Identifier Source: org_study_id
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