A Study of tDCS for Swallowing Difficulties in Stroke Patients

July 20, 2015 updated by: Yong-il Shin, Pusan National University

Improvement of Swallowing Function of Stroke Patients by Dual Transcranial Direct Current Stimulation(tDCS)

The primary objective of this study is to investigate whether the dual transcranial direct current stimulation(tDCS) improves the swallowing function of stroke patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

120 patients were recruited and randomized to receive either real or sham-tDCS. Real experimental groups were divided into three types; Anode-Anode dual stimulation group, Anode-Cathode dual stimulation group, Single stimulation group. 20-minutes session of the stimulation were applied 5 times a weeks for 2 weeks at pharyngeal motor cortex of affected or non-affected site. The patients were evaluated at baseline, immediately and 2 weeks after tDCS.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Yangsan, Korea, Republic of, 626-770
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:
          • Yong Il Shin, MD.PhD
          • Phone Number: 82-55-360-2872 82-55-360-2872
          • Email: rmshin01@gmail.com
        • Principal Investigator:
          • Yong Il Shin, MD.PhD

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Subjects who have diagnosed as primary stroke by physician's physical exam or radiologic diagnosis
  • Subjects who have cortical or subcortical brain lesion
  • Subjects who was diagnosed as stroke within 6 months
  • Subjects ages from 18years to 80years old
  • Subjects who have less than 5 points of DOSS score due to swallowing difficulty from CNS injury
  • Subjects who is possible to receive swallowing function intervention 5 days a week
  • Subjects who understand the purpose of the study and acquired the consent of the patient or caregiver
  • Subjects who had no effect from brain stimulation or electrical stimulation therapy

Exclusion Criteria

  • Subjects who have pre-existing and active major neurological disease
  • Subjects who have pre-existing and active major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
  • Subjects who have brain lesion except cortex or subcortex area
  • Subjects who have any metal component after brain surgery, low threshold to pain, history of seizure
  • Subjects who is estimated as not appropriate for the study by the investigators

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eldith DC-STIMULATOR group

Intervention:

20-minutes of transcranial Direct Current Stimulation (tDCS) application 5 days a week for 2 weeks (30 applications for each 3 groups: total 90 applications)
Device: Eldith DC-STIMULATOR

Transcranical direct current stimulator (Neuroconn GmbH, Ilmenau, Germany) approved by Conformity European as safe treatment device for stroke patients

tDCS intervention]

  • Intensity: 1.5mA for 20min Device: Neuroconn GmbH, Ilmenau, Germany

  • Stimulation site

    • Anode-Anode dual stimulation group Anode: affected pharyngeal motor cortex / Cathode: affected supraorbit Anode: non-affected pharyngeal motor cortex / Cathode: non-affected supraorbit
    • Anode-Cathode dual stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected pharyngeal motor cortex
    • Single stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected supraorbit Sham stimulation
Sham Comparator: sham-Eldith DC-STIMULATOR group
Intervention: 20-minutes of sham-tDCS application 5 days a week for 2 weeks (total 30 applications)
Device: Sham Eldith DC-STIMULATOR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS)
Time Frame: up to 60 sec
up to 60 sec

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Speech-LanguageHearing Association(ASHA)-Norms
Time Frame: up to 2 weeks after tDCS
Change in swallowing function
up to 2 weeks after tDCS
Korean Version of Modified Barthel Index(K-MBI)
Time Frame: up to 2 weeks after tDCS
Change in activity of daily living
up to 2 weeks after tDCS
Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing
Time Frame: 2 weeks after tDCS
Change in swallowing function
2 weeks after tDCS

Collaborators and Investigators

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

Sponsor

Pusan National University

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

April 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 13, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 20, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNUYH-03-2015-004

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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