Comparing Effects of Various Combinations of 6 Hertz(Hz) rTMS & LFrTMS on Motor Recovery Due to Cerebrovascular Disease

Cerebrovascular Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03012204
• Other study ID #: 121-2016010
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2017
• Last updated: March 14, 2017
• Start date: February 16, 2017
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Beijing Hospital
• Contact: Jin Xing, M.D.
• Phone: +86-13521278542
• Email: zhuanglixingjin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effects of various combinations between 6 hertz(Hz) rTMS & LFrTMS on the limb motor dysfunction due to cerebral vascular disease.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Disease
• Cerebrovascular Disorders

Intervention

Device:
• 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: ?6 hertz(Hz) rTMS at unaffected M1 before LFrTMS at unaffected M1 ;?6 Hz rTMS at affected M1;?1 Hz rTMS at unaffected M1. The four groups are the combinations of real or sham ?/?/?.
• 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: ?6 hertz(Hz) rTMS at unaffected M1 before LFrTMS at unaffected M1 ;?6 Hz rTMS at affected M1;?1 Hz rTMS at unaffected M1. The four groups are the combinations of real or sham ?/?/?.
• 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: ?6 hertz(Hz) rTMS at unaffected M1 before LFrTMS at unaffected M1 ;?6 Hz rTMS at affected M1;?1 Hz rTMS at unaffected M1. The four groups are the combinations of real or sham ?/?/?.
• all sham stimulation
used as controls to eliminate the placebo effect of all kinds of combinated rTMS

Locations

Country	Name	City	State
China	Beijing Hospital, National Center of Gerontology	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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