Transcranial Direct Current Stimulation (TDCS) for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Stroke
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|ClinicalTrials.gov Identifier: NCT01132066|
Recruitment Status : Completed
First Posted : May 27, 2010
Last Update Posted : February 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dysphagia||Other: tDCS Other: Sham||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Pilot Study of Transcranial Direct Current Stimulation for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Infarction|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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
- Dysphagia Outcome and Severity Scale Score (DOSS) [ Time Frame: 5 days after study enrollment ]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 ]Number of patient having seizures during the 5 sessions of stimulation in either groups will be tabulated and compared.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01132066
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Sandeep Kumar, MD||Beth Israel Deaconess Medical Center|