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Effects of Brain Network by Simultaneous Dual-mode Stimulation in Subacute Stroke Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279640
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE September 10, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date September 14, 2017
Actual Study Start Date  ICMJE March 1, 2014
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2017)
Neuroimaging Assessment [ Time Frame: Change from baseline resting-state brain network at 8 weeks after intervention ]
Resting-state fMRI
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Brain Network by Simultaneous Dual-mode Stimulation in Subacute Stroke Patients
Official Title  ICMJE Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study
Brief Summary Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both rTMS and tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single rTMS stimulation in subacute stroke patients.
Detailed Description Investigators assessed each patient's motor function using the Fugl-Meyer Assessment (FMA) score and acquired their resting-state fMRI (rs-fMRI) data at two times: prior to stimulation and 2 months after stimulation. Changes in rs-fMRI network measures were investigated between groups.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Motor Disorder
Intervention  ICMJE
  • Device: rTMS on ipsilesional M1
  • Device: tDCS on contralesional M1
Study Arms  ICMJE
  • Experimental: Dual-mode stimulation

    rTMS on ipsilesional M1 + tDCS on contralesional M1

    10 Hz of rTMS was applied over the ipsilesional M1 for 20 minutes with simultaneous application of cathodal tDCS on the contralesional M1.

    Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.

    Interventions:
    • Device: rTMS on ipsilesional M1
    • Device: tDCS on contralesional M1
  • Experimental: Single stimulation

    rTMS on ipsilesional M1

    10 Hz of rTMS over the ipsilesional M1 was applied for 20 minutes.

    Each participant's total FMA score is assessed and their resting-state fMRI data at two times: prior to stimulation (pre-stimulation) and 2 months after stimulation (post-stimulation) are acquired.

    Intervention: Device: rTMS on ipsilesional M1
Publications * Lee J, Park E, Lee A, Chang WH, Kim DS, Shin YI, Kim YH. Modulating Brain Connectivity by Simultaneous Dual-Mode Stimulation over Bilateral Primary Motor Cortices in Subacute Stroke Patients. Neural Plast. 2018 Feb 13;2018:1458061. doi: 10.1155/2018/1458061. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2017)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • First-ever stroke patients
  • Subacute stage (less than 4 weeks)
  • Total Fugl-Meyer Assessment (FMA) score under 84

Exclusion Criteria:

  • Major active neurological disease or psychiatric disease
  • A history of seizure
  • Metallic implants in their brain
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03279640
Other Study ID Numbers  ICMJE 2013-06-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yun-Hee Kim, MD, PhD Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP