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

September 12, 2017 updated by: Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuroimaging Assessment
Time Frame: Change from baseline resting-state brain network at 8 weeks after intervention
Resting-state fMRI
Change from baseline resting-state brain network at 8 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2014

Primary Completion (ACTUAL)

February 28, 2017

Study Completion (ACTUAL)

February 28, 2017

Study Registration Dates

First Submitted

September 10, 2017

First Submitted That Met QC Criteria

September 10, 2017

First Posted (ACTUAL)

September 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-06-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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