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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132066
• Other study ID #: 2007P-000102
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 17, 2010
• Last updated: February 27, 2014
• Start date: April 2007
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysphagia

Intervention

Other:
• tDCS
tDCS will lead to an increase in cortical excitability
• Sham
Sham will provide identical subjective sensation as tDCS

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kumar S, Wagner CW, Frayne C, Zhu L, Selim M, Feng W, Schlaug G. Noninvasive brain stimulation may improve stroke-related dysphagia: a pilot study. Stroke. 2011 Apr;42(4):1035-40. doi: 10.1161/STROKEAHA.110.602128. Epub 2011 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia Outcome and Severity Scale Score (DOSS)	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.	5 days after study enrollment	No
Secondary	Incidence of seizure	Number of patient having seizures during the 5 sessions of stimulation in either groups will be tabulated and compared.	5 days after study enrollment	Yes