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tDCS and Aphasia Treatment

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Soterix 1x1 tDCS
Sponsored by
Hunter College of City University of New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring aphasia, therapy, stroke, language, naming, quality of life, tDCS, treatment

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Hunter College Brookdale Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anodal tDCS

Arm Description

Soterix 1x1 device: anodal tDCS administered to the left hemisphere

Outcomes

Primary Outcome Measures

change in naming performance in singles words and sentence context
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
Sentence production will be classified.
change in health related quality of life
Scales of health related quality of life will be implemented.

Full Information

First Posted
August 2, 2013
Last Updated
August 13, 2020
Sponsor
Hunter College of City University of New York
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1. Study Identification

Unique Protocol Identification Number
NCT01922245
Brief Title
tDCS and Aphasia Treatment
Official Title
tDCS and Aphasia Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter College of City University of New York

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
aphasia, therapy, stroke, language, naming, quality of life, tDCS, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anodal tDCS
Arm Type
Experimental
Arm Description
Soterix 1x1 device: anodal tDCS administered to the left hemisphere
Intervention Type
Device
Intervention Name(s)
Soterix 1x1 tDCS
Intervention Description
Anodal and sham tDCS will be administered. All of the participants will also receive behavioral speech-language therapy.
Primary Outcome Measure Information:
Title
change in naming performance in singles words and sentence context
Description
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.
Time Frame
change from baseline naming performance at two weeks and four weeks post treatment
Secondary Outcome Measure Information:
Title
change in sentence production
Description
Sentence production will be classified.
Time Frame
change from baseline performance at two weeks and four weeks post treatment
Title
change in health related quality of life
Description
Scales of health related quality of life will be implemented.
Time Frame
change from baseline performance at two weeks and four weeks post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth E Galletta, PhD
Organizational Affiliation
Hunter College/City University of NY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter College Brookdale Campus
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20395612
Citation
Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.
Results Reference
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PubMed Identifier
23785323
Citation
Fiori V, Cipollari S, Di Paola M, Razzano C, Caltagirone C, Marangolo P. tDCS stimulation segregates words in the brain: evidence from aphasia. Front Hum Neurosci. 2013 Jun 14;7:269. doi: 10.3389/fnhum.2013.00269. eCollection 2013.
Results Reference
background
PubMed Identifier
23799617
Citation
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving aphasia in patients after stroke. Cochrane Database Syst Rev. 2013 Jun 25;(6):CD009760. doi: 10.1002/14651858.CD009760.pub2.
Results Reference
result

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tDCS and Aphasia Treatment

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