Clinical trial NCT03012204: Comparing Effects of Various Combinations of 6 Hertz(Hz) rTMS & LFrTMS on Motor Recovery Due to Cerebrovascular Disease
Official title: Series Study About the rTMS Effects on the Recovery of Limb Motor Dysfunction Due to Cerebral Vascular Disease, Part 1: Comparing the Effects of Various Combinations Between 6 Hertz(Hz) rTMS & LFrTMS.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Disease
Keywords: Cerebrovascular Disease
Repetitive Transcranial Magnetic Stimulation
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2017-01-06
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer assessment (FMA)
timeFrame: 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
measure: Simple Test for Evaluating Hand Function (STEF)
timeFrame: 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
Secondary outcomes:
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital, National Center of Gerontology
state: Beijing
Study officials:
affiliation: Beijing Hospital, National Center of Gerontology, China
name: Li Zhuang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.