Transcranial Direct Current Stimulation (TDCS) for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Stroke
Recruitment status was Recruiting
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|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (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
|Contact: Sandeep Kumar, MDemail@example.com|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Sandeep Kumar, MD 617-632-8917 firstname.lastname@example.org|
|Principal Investigator:||Sandeep Kumar, MD||Beth Israel Deaconess Medical Center|