Transcranial Direct Current Stimulation (TDCS) for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Stroke
Pilot Study of Transcranial Direct Current Stimulation for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Infarction
1 other identifier
interventional
19
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2007
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 17, 2010
CompletedFirst Posted
Study publicly available on registry
May 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFebruary 28, 2014
February 1, 2014
6.1 years
May 17, 2010
February 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Incidence of seizure
5 days after study enrollment
Study Arms (2)
tDCS
EXPERIMENTALtDCS will provide an increase in cortical excitability. Patients will be randomized to receive tDCS or sham stimulation.
sham
PLACEBO COMPARATORSham stimulation will provide identical subjective sensation as anodal tDCS.
Interventions
Eligibility Criteria
You may qualify if:
- Acute ischemic stroke
- Between 24-168 hours after onset
- Moderate to severe dysphagia based on swallowing assessment
You may not qualify if:
- Preexisting swallowing impairment
- Intracerebral hemorrhage
- Pacemaker of other electrically sensitive device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Related 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.
PMID: 21441148RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandeep Kumar, MD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Neurology
Study Record Dates
First Submitted
May 17, 2010
First Posted
May 27, 2010
Study Start
April 1, 2007
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
February 28, 2014
Record last verified: 2014-02