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

Primary Purpose

Stroke, Motor Disorder

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

rTMS on ipsilesional M1

tDCS on contralesional M1

About this trial

This is an interventional treatment trial for Stroke focused on measuring Motor Network, Resting-state fMRI, Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Dual-mode stimulation

Single stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Neuroimaging Assessment

Resting-state fMRI

Secondary Outcome Measures

Full Information

NCT ID

NCT03279640

First Posted

September 10, 2017

Last Updated

September 12, 2017

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03279640

Brief Title

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

Official Title

Investigation for Individualized Noninvasive Neuromodulation in Neurorehabilitation of Brain Disease: Longitudinal Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

March 1, 2014 (Actual)

Primary Completion Date

February 28, 2017 (Actual)

Study Completion Date

February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Motor Disorder

Keywords

Motor Network, Resting-state fMRI, Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dual-mode stimulation

Arm Type

Experimental

Arm Description

Arm Title

Single stimulation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

rTMS on ipsilesional M1

Intervention Type

Device

Intervention Name(s)

tDCS on contralesional M1

Primary Outcome Measure Information:

Title

Neuroimaging Assessment

Description

Resting-state fMRI

Time Frame

Change from baseline resting-state brain network at 8 weeks after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yun-Hee Kim, MD, PhD

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29666636

Citation

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.

Results Reference

derived

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

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