A Study of tDCS for Swallowing Difficulties in Stroke Patients

Not Applicable

• Conditions: Stroke
• Interventions: Device: Eldith DC-STIMULATOR; Device: Sham Eldith DC-STIMULATOR

• Registration Number: NCT02422225
• Lead Sponsor: Pusan National University

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-20
• Study First Posted: 2015-04-21
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-22
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eldith DC-STIMULATOR group	Eldith DC-STIMULATOR	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)
sham-Eldith DC-STIMULATOR group	Sham Eldith DC-STIMULATOR	Intervention: 20-minutes of sham-tDCS application 5 days a week for 2 weeks (total 30 applications)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of