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Transcranial Direct Current Stimulation (TDCS) for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01132066
First received: May 17, 2010
Last updated: April 7, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Dysphagia
 Other: tDCS
Other: Sham
 Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
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)
Arms Assigned Interventions
Experimental: tDCS
tDCS will provide an increase in cortical excitability. Patients will be randomized to receive tDCS or sham stimulation.
 Other: tDCS
tDCS will lead to an increase in cortical excitability
Placebo Comparator: sham
Sham stimulation will provide identical subjective sensation as anodal tDCS.
 Other: Sham
Sham will provide identical subjective sensation as tDCS

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132066

Contacts
Contact: Sandeep Kumar, MD 617-632-8917 skumar@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sandeep Kumar, MD     617-632-8917     skumar@bidmc.harvard.edu    
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Sandeep Kumar, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Sandeep Kumar, M.D/ Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01132066     History of Changes
Other Study ID Numbers: 2007P-000102
Study First Received: May 17, 2010
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
swallowing
stroke

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013