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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:
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 20, 2014