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

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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

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.

Condition or disease Intervention/treatment Phase
Stroke Motor Disorder Device: rTMS on ipsilesional M1 Device: tDCS on contralesional M1 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Arm Intervention/treatment
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.

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.

Device: rTMS on ipsilesional M1



Primary Outcome Measures :
  1. Neuroimaging Assessment [ Time Frame: Change from baseline resting-state brain network at 8 weeks after intervention ]
    Resting-state fMRI



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03279640


Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Yun-Hee Kim, MD, PhD Samsung Medical Center
  Study Documents (Full-Text)

Documents provided by Samsung Medical Center:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03279640    
Other Study ID Numbers: 2013-06-002
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Samsung Medical Center:
Motor Network
Resting-state fMRI
Repetitive Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
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Stroke
Motor Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Mental Disorders