NCT02422225

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

8 months

First QC Date

April 13, 2015

Last Update Submit

July 20, 2015

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

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

    up to 60 sec

Secondary Outcomes (3)

  • American Speech-LanguageHearing Association(ASHA)-Norms

    up to 2 weeks after tDCS

  • Korean Version of Modified Barthel Index(K-MBI)

    up to 2 weeks after tDCS

  • Dysphagia Outcome and Severity Scale(DOSS) from video fluoroscopic swallowing

    2 weeks after tDCS

Study Arms (2)

Eldith DC-STIMULATOR group

EXPERIMENTAL

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

sham-Eldith DC-STIMULATOR group

SHAM COMPARATOR

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

Device: Sham Eldith DC-STIMULATOR

Interventions

Eldith DC-STIMULATORDEVICE

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

Eldith DC-STIMULATOR group
Sham Eldith DC-STIMULATORDEVICE
sham-Eldith DC-STIMULATOR group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, 626-770, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 20407308BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Yong-Il Shin, Ph.D.

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 21, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

July 22, 2015

Record last verified: 2015-07

Locations

KR(1)