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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandeep Kumar, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01132066
First received: May 17, 2010
Last updated: February 27, 2014
Last verified: February 2014
  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 1
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:


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.


Enrollment: 19
Study Start Date: April 2007
Study Completion Date: May 2013
Primary Completion Date: May 2013 (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

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Sandeep Kumar, MD Beth Israel Deaconess Medical Center
  More Information

Publications:
Responsible Party: Sandeep Kumar, Assistant Professor of Neurology, 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: February 27, 2014
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 April 17, 2014