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OpenTrials
Completed

NCT Number: NCT01132066

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Other

tDCS will lead to an increase in cortical excitability

SHAM

Other

Sham will provide identical subjective sensation as tDCS

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Pilot Study of Transcranial Direct Current Stimulation for Facilitating Swallowing Improvement After an Acute Unilateral Hemispheric Infarction

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
May 27, 2010
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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