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

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ClinicalTrials.gov Identifier: NCT03012204
Recruitment Status : Unknown
Verified March 2017 by ZHUANG Li, MD, Beijing Hospital.
Recruitment status was:  Recruiting
First Posted : January 6, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
ZHUANG Li, MD, Beijing Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Disease Device: real LFrTMS at unaffected M1 Device: real primed LFrTMS at unaffected M1 Device: combined rTMS at both M1 Device: all sham stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Device: 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.


Experimental: 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
Device: 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.


Active Comparator: 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
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: 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.


Sham Comparator: 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
Device: all sham stimulation
used as controls to eliminate the placebo effect of all kinds of combinated rTMS




Primary Outcome Measures :
  1. Fugl-Meyer assessment (FMA) [ Time Frame: 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

  2. Simple Test for Evaluating Hand Function (STEF) [ Time Frame: 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 Outcome Measures :
  1. National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012204


Contacts
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Contact: Jin Xing, M.D. +86-13521278542 zhuanglixingjin@163.com
Contact: Xinxin Ma, M.D +86-15901043667 zhuanglixingjin@163.com

Locations
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China, Beijing
Beijing Hospital, National Center of Gerontology Recruiting
Beijing, Beijing, China, 100730
Contact: Xin Wang         
Sponsors and Collaborators
Beijing Hospital
Investigators
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Principal Investigator: Li Zhuang, M.D. Beijing Hospital, National Center of Gerontology, China
Publications:
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Responsible Party: ZHUANG Li, MD, Chief Physician, Beijing Hospital
ClinicalTrials.gov Identifier: NCT03012204    
Other Study ID Numbers: 121-2016010
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ZHUANG Li, MD, Beijing Hospital:
Cerebrovascular Disease
Repetitive Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases