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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01132066
First Posted: May 27, 2010
Last Update Posted: February 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sandeep Kumar, Beth Israel Deaconess Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Sandeep Kumar, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


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
First Submitted: May 17, 2010
First Posted: May 27, 2010
Last Update Posted: February 28, 2014
Last Verified: February 2014

Keywords provided by Sandeep Kumar, Beth Israel Deaconess Medical Center:
swallowing
stroke