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NCT01132066 Clinical Trial

Transcranial Direct Current Stimulation (TDCS) for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Stroke

Dysphagia Clinical Trial

Official title:
Pilot Study of Transcranial Direct Current Stimulation for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Infarction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01132066
Other study ID # 2007P-000102
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received May 17, 2010
Last updated February 27, 2014
Start date April 2007
Est. completion date May 2013

Study information
Verified date February 2014
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the research study is to investigate the effect of a brain stimulation technique called Transcranial Direct Current Stimulation (TDCS) in improving swallowing functions in subjects who develop dysphagia after a unilateral hemispheric infarction.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- Acute ischemic stroke

- Between 24-168 hours after onset

- Moderate to severe dysphagia based on swallowing assessment

Exclusion Criteria:

- Preexisting swallowing impairment

- Intracerebral hemorrhage

- Pacemaker of other electrically sensitive device

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• tDCS
tDCS will lead to an increase in cortical excitability
• Sham
Sham will provide identical subjective sensation as tDCS

Locations
Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kumar S, Wagner CW, Frayne C, Zhu L, Selim M, Feng W, Schlaug G. Noninvasive brain stimulation may improve stroke-related dysphagia: a pilot study. Stroke. 2011 Apr;42(4):1035-40. doi: 10.1161/STROKEAHA.110.602128. Epub 2011 Mar 24. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Dysphagia Outcome and Severity Scale Score (DOSS) DOSS is a validated swallowing assessment scoring system that will rate the severity of dysphagia. It will be performed by a speech and swallow pathologist. 5 days after study enrollment No
Secondary Incidence of seizure Number of patient having seizures during the 5 sessions of stimulation in either groups will be tabulated and compared. 5 days after study enrollment Yes
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