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

NCT ID: NCT01132066

Last Updated: 2014-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tDCS

tDCS will provide an increase in cortical excitability. Patients will be randomized to receive tDCS or sham stimulation.

Group Type EXPERIMENTAL

tDCS

Intervention Type OTHER

tDCS will lead to an increase in cortical excitability

sham

Sham stimulation will provide identical subjective sensation as anodal tDCS.

Group Type PLACEBO_COMPARATOR

Sham

Intervention Type OTHER

Sham will provide identical subjective sensation as tDCS

Interventions

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tDCS

tDCS will lead to an increase in cortical excitability

Intervention Type OTHER

Sham

Sham will provide identical subjective sensation as tDCS

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sandeep Kumar

Assistant Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandeep Kumar, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21441148 (View on PubMed)

Other Identifiers

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2007P-000102

Identifier Type: -

Identifier Source: org_study_id

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