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

NCT ID: NCT03279640

Last Updated: 2017-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-01

Study Completion Date

2017-02-28

Brief Summary

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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

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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.

Conditions

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Stroke Motor Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

rTMS on ipsilesional M1

Intervention Type DEVICE

tDCS on contralesional M1

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

rTMS on ipsilesional M1

Intervention Type DEVICE

Interventions

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rTMS on ipsilesional M1

Intervention Type DEVICE

tDCS on contralesional M1

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yun-Hee Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

References

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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.

Reference Type DERIVED
PMID: 29666636 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2013-06-002

Identifier Type: -

Identifier Source: org_study_id

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