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A Study of tDCS for Swallowing Difficulties in Stroke Patients

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Eldith DC-STIMULATOR
Sham Eldith DC-STIMULATOR
Sponsored by
Pusan National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pusan National University Yangsan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Eldith DC-STIMULATOR group

sham-Eldith DC-STIMULATOR group

Arm Description

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)

Intervention: 20-minutes of sham-tDCS application 5 days a week for 2 weeks (total 30 applications)

Outcomes

Primary Outcome Measures

Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS)

Secondary Outcome Measures

American Speech-LanguageHearing Association(ASHA)-Norms
Change in swallowing function
Korean Version of Modified Barthel Index(K-MBI)
Change in activity of daily living
Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing
Change in swallowing function

Full Information

First Posted
April 13, 2015
Last Updated
July 20, 2015
Sponsor
Pusan National University
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1. Study Identification

Unique Protocol Identification Number
NCT02422225
Brief Title
A Study of tDCS for Swallowing Difficulties in Stroke Patients
Official Title
Improvement of Swallowing Function of Stroke Patients by Dual Transcranial Direct Current Stimulation(tDCS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eldith DC-STIMULATOR group
Arm Type
Experimental
Arm Description
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)
Arm Title
sham-Eldith DC-STIMULATOR group
Arm Type
Sham Comparator
Arm Description
Intervention: 20-minutes of sham-tDCS application 5 days a week for 2 weeks (total 30 applications)
Intervention Type
Device
Intervention Name(s)
Eldith DC-STIMULATOR
Intervention Description
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 <Experimental group> 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 <Control group> Sham stimulation
Intervention Type
Device
Intervention Name(s)
Sham Eldith DC-STIMULATOR
Primary Outcome Measure Information:
Title
Change in Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing study(VFSS)
Time Frame
up to 60 sec
Secondary Outcome Measure Information:
Title
American Speech-LanguageHearing Association(ASHA)-Norms
Description
Change in swallowing function
Time Frame
up to 2 weeks after tDCS
Title
Korean Version of Modified Barthel Index(K-MBI)
Description
Change in activity of daily living
Time Frame
up to 2 weeks after tDCS
Title
Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing
Description
Change in swallowing function
Time Frame
2 weeks after tDCS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong-Il Shin, Ph.D.
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
ZIP/Postal Code
626-770
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Il Shin, MD.PhD
Phone
82-55-360-2872
Ext
82-55-360-2872
Email
rmshin01@gmail.com
First Name & Middle Initial & Last Name & Degree
Yong Il Shin, MD.PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20407308
Citation
Lequerica AH, Kortte K. Therapeutic engagement: a proposed model of engagement in medical rehabilitation. Am J Phys Med Rehabil. 2010 May;89(5):415-22. doi: 10.1097/PHM.0b013e3181d8ceb2.
Results Reference
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A Study of tDCS for Swallowing Difficulties in Stroke Patients

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