Cerebrovascular Disease
Conditions
Keywords
Cerebrovascular Disease, Repetitive Transcranial Magnetic Stimulation
Brief summary
To compare the effects of various combinations between 6 hertz(Hz) rTMS & LFrTMS on the limb motor dysfunction due to cerebral vascular disease.
Detailed description
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.
Interventions
DEVICEreal 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.
DEVICEreal 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.
DEVICEcombined 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.
DEVICEall sham stimulation
used as controls to eliminate the placebo effect of all kinds of combinated rTMS
Sponsors
Beijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Aged from 30 to 90 years; * 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
* during pregnancy; * with skull defect; * with metal implants, cardiac pacemaker, cochlear implantation; * epileptiform discharge in EEG.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer assessment (FMA) | 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 | Score of Fugl-Meyer assessment |
| Simple Test for Evaluating Hand Function (STEF) | 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 | Score of Simple Test for Evaluating Hand Function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| National Institute of Health Stroke Scale (NIHSS) | 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 | Score of National Institute of Health Stroke Scale |
Countries
China
Contacts
Primary ContactJin Xing, M.D.
Backup ContactXinxin Ma, M.D
Outcome results
None listed