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

Primary Purpose

Cerebrovascular Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
real LFrTMS at unaffected M1
real primed LFrTMS at unaffected M1
combined rTMS at both M1
all sham stimulation
Sponsored by
Beijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Disease focused on measuring Cerebrovascular Disease, Repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Hospital, National Center of GerontologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Sham Comparator

Arm Label

combined rTMS at both M1

real primed LFrTMS at unaffected M1

real LFrTMS at unaffected M1

all sham stimulation

Arm Description

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

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 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

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

Outcomes

Primary Outcome Measures

Fugl-Meyer assessment (FMA)
Score of Fugl-Meyer assessment
Simple Test for Evaluating Hand Function (STEF)
Score of Simple Test for Evaluating Hand Function

Secondary Outcome Measures

National Institute of Health Stroke Scale (NIHSS)
Score of National Institute of Health Stroke Scale

Full Information

First Posted
January 4, 2017
Last Updated
March 14, 2017
Sponsor
Beijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03012204
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disease
Keywords
Cerebrovascular Disease, Repetitive Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combined rTMS at both M1
Arm Type
Experimental
Arm Description
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
Arm Title
real primed LFrTMS at unaffected M1
Arm Type
Experimental
Arm Description
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
Arm Title
real LFrTMS at unaffected M1
Arm Type
Active Comparator
Arm Description
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
Arm Title
all sham stimulation
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
real LFrTMS at unaffected M1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
real primed LFrTMS at unaffected M1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
combined rTMS at both M1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
all sham stimulation
Intervention Description
used as controls to eliminate the placebo effect of all kinds of combinated rTMS
Primary Outcome Measure Information:
Title
Fugl-Meyer assessment (FMA)
Description
Score of Fugl-Meyer assessment
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
Title
Simple Test for Evaluating Hand Function (STEF)
Description
Score of Simple Test for Evaluating Hand Function
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
Secondary Outcome Measure Information:
Title
National Institute of Health Stroke Scale (NIHSS)
Description
Score of National Institute of Health Stroke Scale
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Xing, M.D.
Phone
+86-13521278542
Email
zhuanglixingjin@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xinxin Ma, M.D
Phone
+86-15901043667
Email
zhuanglixingjin@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhuang, M.D.
Organizational Affiliation
Beijing Hospital, National Center of Gerontology, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital, National Center of Gerontology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23532011
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.
Results Reference
background
PubMed Identifier
24422912
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.
Results Reference
background
PubMed Identifier
20026185
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.
Results Reference
background
PubMed Identifier
26198365
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.
Results Reference
background
PubMed Identifier
17876070
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.
Results Reference
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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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