NCT03012204

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

February 16, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

January 4, 2017

Last Update Submit

March 14, 2017

Conditions

Cerebrovascular Disease

Keywords

Cerebrovascular DiseaseRepetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • 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

Study Arms (4)

combined rTMS at both M1

EXPERIMENTAL

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

real primed LFrTMS at unaffected M1

EXPERIMENTAL

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

real LFrTMS at unaffected M1

ACTIVE COMPARATOR

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

all sham stimulation

SHAM COMPARATOR

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

Interventions

real LFrTMS at unaffected M1DEVICE

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.

real LFrTMS at unaffected M1
real primed LFrTMS at unaffected M1DEVICE

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.

real primed LFrTMS at unaffected M1
combined rTMS at both M1DEVICE

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.

combined rTMS at both M1
all sham stimulationDEVICE

used as controls to eliminate the placebo effect of all kinds of combinated rTMS

all sham stimulation

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • during pregnancy;
  • with skull defect;
  • with metal implants, cardiac pacemaker, cochlear implantation;
  • epileptiform discharge in EEG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Hospital, National Center of Gerontology

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 23532011BACKGROUND

  • 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.

    PMID: 24422912BACKGROUND

  • 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.

    PMID: 20026185BACKGROUND

  • 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.

    PMID: 26198365BACKGROUND

  • 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.

    PMID: 17876070BACKGROUND

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Li Zhuang, M.D.

    Beijing Hospital, National Center of Gerontology, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Xing, M.D.

CONTACT

+86-13521278542zhuanglixingjin@163.com

Xinxin Ma, M.D

CONTACT

+86-15901043667zhuanglixingjin@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 6, 2017

Study Start

February 16, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 15, 2017

Record last verified: 2017-03

Locations

CN(1)