Back to resultsTranscranial Direct Current Stimulation (TDCS) for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Stroke
Primary Purpose
Dysphagia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Dysphagia focused on measuring swallowing, stroke
Eligibility Criteria
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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
tDCS
sham
Arm Description
tDCS will provide an increase in cortical excitability. Patients will be randomized to receive tDCS or sham stimulation.
Sham stimulation will provide identical subjective sensation as anodal tDCS.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Incidence of seizure
Number of patient having seizures during the 5 sessions of stimulation in either groups will be tabulated and compared.
Full Information
NCT ID
NCT01132066
First Posted
May 17, 2010
Last Updated
February 27, 2014
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01132066
Brief Title
Transcranial Direct Current Stimulation (TDCS) for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Stroke
Official Title
Pilot Study of Transcranial Direct Current Stimulation for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphagia
Keywords
swallowing, stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tDCS
Arm Type
Experimental
Arm Description
tDCS will provide an increase in cortical excitability. Patients will be randomized to receive tDCS or sham stimulation.
Arm Title
sham
Arm Type
Placebo Comparator
Arm Description
Sham stimulation will provide identical subjective sensation as anodal tDCS.
Intervention Type
Other
Intervention Name(s)
tDCS
Intervention Description
tDCS will lead to an increase in cortical excitability
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Sham will provide identical subjective sensation as tDCS
Primary Outcome Measure Information:
Title
Dysphagia Outcome and Severity Scale Score (DOSS)
Description
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.
Time Frame
5 days after study enrollment
Secondary Outcome Measure Information:
Title
Incidence of seizure
Description
Number of patient having seizures during the 5 sessions of stimulation in either groups will be tabulated and compared.
Time Frame
5 days after study enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandeep Kumar, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21441148
Citation
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.
Results Reference
result
Learn more about this trial
Transcranial Direct Current Stimulation (TDCS) for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Stroke
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