tDCS and Aphasia Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Hunter College
Sponsor:
Information provided by (Responsible Party):
Elizabeth Galletta, Hunter College
ClinicalTrials.gov Identifier:
NCT01922245
First received: August 2, 2013
Last updated: January 30, 2015
Last verified: January 2015
  Purpose

This project will investigate the use of noninvasive brain stimulation in the form of tDCS (transcranial direct current stimulation) in conjunction with speech-language therapy, for the improvement of language production in stroke survivors with aphasia. The hypothesis is that anodal tDCS and speech-language therapy will facilitate improved outcomes compared to speech therapy alone.


Condition Intervention
Aphasia
Device: Soterix 1x1 tDCS

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: tDCS and Aphasia Treatment

Resource links provided by NLM:


Further study details as provided by Hunter College:

Primary Outcome Measures:
  • change in naming performance in singles words and sentence context [ Time Frame: change from baseline naming performance at two weeks and four weeks post treatment ] [ Designated as safety issue: No ]
    Naming will be tested using standardized tests such at the Boston Naming Test and or the Philadelphia Naming Test. In addition, sentence probes have been created that will assess naming in the sentence context throughout the study.


Secondary Outcome Measures:
  • change in sentence production [ Time Frame: change from baseline performance at two weeks and four weeks post treatment ] [ Designated as safety issue: No ]
    Sentence production will be classified.

  • change in health related quality of life [ Time Frame: change from baseline performance at two weeks and four weeks post treatment ] [ Designated as safety issue: No ]
    Scales of health related quality of life will be implemented.


Estimated Enrollment: 20
Study Start Date: July 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anodal tDCS
Soterix 1x1 device: anodal tDCS administered to the left hemisphere
Device: Soterix 1x1 tDCS
Anodal and sham tDCS will be administered. All of the participants will also receive behavioral speech-language therapy.

Detailed Description:

Aphasia, commonly defined as impairment or loss of language functions, is a frequent and often chronic consequence of stroke, with detrimental effects on patient autonomy and health-related quality of life (HRQOL). Although beneficial in some cases, the effectiveness of behavioral therapy is often limited, and therefore new complementary treatments must be developed in order to improve rehabilitation of post-stroke aphasia.

In most individuals, language areas in the brain are localized in the left hemisphere. After stroke, there is evidence that the brain reorganizes such that either areas close to damaged language areas in the Left Hemisphere, or anatomically similar areas in the Right Hemisphere, are recruited to perform language tasks.

Recently, studies have begun to examine the effects of non-invasive brain stimulation on aphasia rehabilitation. One such technique is transcranial direct current stimulation (tDCS), which involves administering weak electrical currents through surface electrodes on the scalp. The effects can either stimulate an area, or inhibit an area of the brain. The main hypothesis is that stimulating language areas in the Left Hemisphere in conjunction with speech language therapy will facilitate reorganization of language-relevant areas of the brain, and improve expression.

The proposed study will compare the effects of transcranial direct current stimulation (tDCS) activating language centers in the Left Hemisphere and sham tDCS, in right-handed individuals with chronic post-stroke aphasia. This study will provide information on the effects of tDCS, in conjunction with speech-language therapy, on aphasia rehabilitation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: single left hemisphere stroke, more than three months post stroke, right handed, no other medical problems, ages 18-100 -

Exclusion Criteria: more than one stroke, less than three months post stroke, other medical problems, pacemaker or other electronic implant (e.g. hip replacement), pregnancy

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  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: NCT01922245

Contacts
Contact: Elizabeth Galletta, PhD 914-481-4439 elizabeth.galletta@gmail.com
Contact: Amy Vogel, BA 212-481-4439 amy.vogel@gmail.com

Locations
United States, New York
Hunter College Brookdale Campus Recruiting
New York, New York, United States, 10010
Contact: Elizabeth Galletta, PhD    212-481-4439    elizabeth.galletta@gmail.com   
Principal Investigator: Elizabeth Galletta, PhD         
Sponsors and Collaborators
Hunter College
Investigators
Principal Investigator: Elizabeth E Galletta, PhD Hunter College/City University of NY
  More Information

Publications:
Responsible Party: Elizabeth Galletta, Assistant Professor, Hunter College
ClinicalTrials.gov Identifier: NCT01922245     History of Changes
Other Study ID Numbers: 062951
Study First Received: August 2, 2013
Last Updated: January 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Hunter College:
aphasia
therapy
stroke
language
naming
quality of life
tDCS
treatment

Additional relevant MeSH terms:
Aphasia
Communication Disorders
Language Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Speech Disorders

ClinicalTrials.gov processed this record on March 25, 2015