Transcranial Direct Current Stimulation (TDCS) for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Stroke
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pilot Study of Transcranial Direct Current Stimulation for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Infarction|
- Dysphagia Outcome and Severity Scale Score (DOSS) [ Time Frame: 5 days after study enrollment ] [ Designated as safety issue: No ]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.
- Incidence of seizure [ Time Frame: 5 days after study enrollment ] [ Designated as safety issue: Yes ]Number of patient having seizures during the 5 sessions of stimulation in either groups will be tabulated and compared.
|Study Start Date:||April 2007|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
tDCS will provide an increase in cortical excitability. Patients will be randomized to receive tDCS or sham stimulation.
tDCS will lead to an increase in cortical excitability
Placebo Comparator: sham
Sham stimulation will provide identical subjective sensation as anodal tDCS.
Sham will provide identical subjective sensation as tDCS
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132066
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Sandeep Kumar, MD||Beth Israel Deaconess Medical Center|