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Effects of Transcranial Direct Current Stimulation in Post-stroke Aphasia

Primary Purpose

Aphasia

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active tDCS plus Speech-Language Therapy
Sham plus Speech-Language Therapy
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically diagnosed with with post-stroke aphasia and word-retrieval deficits
  • Premorbid speakers of English
  • Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment
  • Stroke size: any l
  • Location: Left hemisphere strokes only from any etiology.
  • Time since stroke onset: 1 day to 20 years.

Exclusion Criteria:

  • uncorrected visual or hearing impairment by self report
  • other premorbid neurological disorder affecting the brain
  • any other language-based learning disorder or other neurodegenerative disorder such as Alzheimer's Disease or Primary Progressive Aphasia
  • premorbidly diagnosed with a developmental language disorder
  • Pregnant women will also be excluded

Sites / Locations

  • Johns Hopkins Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS plus Speech-Language Therapy

Sham plus Speech-Language Therapy

Arm Description

Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized.

Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized.

Outcomes

Primary Outcome Measures

Change in picture naming scores in trained and untrained items

Secondary Outcome Measures

Change in Philadelphia Naming Test: Picture naming of everyday objects, different from training set
Change in Written naming of objects and actions
The investigators will evaluate the absolute number as well as the percent change of the list of objects and actions assigned for intervention as trained and untrained items.
Change in working memory (digit span)
Change in verbal fluency
The investigators will use letter (F, A, S) and semantic fluency measures (animals, fruits and vegetables) and the investigators will measure how many were added or omitted at follow-up intervals.

Full Information

First Posted
November 17, 2015
Last Updated
November 21, 2018
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02622945
Brief Title
Effects of Transcranial Direct Current Stimulation in Post-stroke Aphasia
Official Title
Transcranial Direct Current Stimulation in Acute and Chronic Post-stroke Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study could not recruit any participant
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study aims to determine whether transcranial direct current stimulation (tDCS) paired with speech-language therapy is more beneficial than speech-language therapy alone in acute and chronic post-stroke aphasia.
Detailed Description
This study aims to determine whether behavioral word-retrieval therapy coupled with anodal tDCS will improve the fluency and name retrieval performance of participants with post-stroke aphasia more efficiently and for greater duration than language therapy alone (i.e. in the sham condition). tDCS neuronal targets will be selected in this order: left posterior superior-middle temporal gyrus (an area critical for word retrieval and word comprehension), left posterior frontal areas found to be responsible for lexical selection if the first area is infarcted, or right cerebellum (important for learning, and consistently activated in naming task) if both of the other areas are infarcted. The same areas will be stimulated during the first tDCS and sham periods. If the participant returns for a second period of tDCS and sham with language therapy, the right cerebellum will be stimulated (if it was the only uninfarcted target area investigators will stimulate this area again). For cerebellar stimulation, either anodal or cathodal will be used as studies show that anodal or cathodal stimulation has an effect on cognitive functions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS plus Speech-Language Therapy
Arm Type
Experimental
Arm Description
Active tDCS will be applied at the beginning of 45min speech-language therapy session and will last for 20 min. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized.
Arm Title
Sham plus Speech-Language Therapy
Arm Type
Sham Comparator
Arm Description
Sham tDCS will be applied at the beginning of 45min speech-language therapy session. Language therapy will be oral and written naming. This is a cross-over study so all participants will receive this arm but the order will be randomized.
Intervention Type
Device
Intervention Name(s)
Active tDCS plus Speech-Language Therapy
Other Intervention Name(s)
Active tDCS and speech-therapy
Intervention Description
Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain not affected by the lesion(perilesional areas, right hemisphere or cerebellum). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.
Intervention Type
Device
Intervention Name(s)
Sham plus Speech-Language Therapy
Other Intervention Name(s)
Sham tDCS plus speech-therapy
Intervention Description
Speech-Language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.
Primary Outcome Measure Information:
Title
Change in picture naming scores in trained and untrained items
Time Frame
Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Secondary Outcome Measure Information:
Title
Change in Philadelphia Naming Test: Picture naming of everyday objects, different from training set
Time Frame
Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Title
Change in Written naming of objects and actions
Description
The investigators will evaluate the absolute number as well as the percent change of the list of objects and actions assigned for intervention as trained and untrained items.
Time Frame
Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Title
Change in working memory (digit span)
Time Frame
Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups
Title
Change in verbal fluency
Description
The investigators will use letter (F, A, S) and semantic fluency measures (animals, fruits and vegetables) and the investigators will measure how many were added or omitted at follow-up intervals.
Time Frame
Before and after 15 sessions of intervention (3 weeks) and at 2 weeks and 2 months follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinically diagnosed with with post-stroke aphasia and word-retrieval deficits Premorbid speakers of English Diagnosis will be based on neuropsychological testing, language testing (most commonly the Western Aphasia Battery), MRI and clinical assessment Stroke size: any l Location: Left hemisphere strokes only from any etiology. Time since stroke onset: 1 day to 20 years. Exclusion Criteria: uncorrected visual or hearing impairment by self report other premorbid neurological disorder affecting the brain any other language-based learning disorder or other neurodegenerative disorder such as Alzheimer's Disease or Primary Progressive Aphasia premorbidly diagnosed with a developmental language disorder Pregnant women will also be excluded
Facility Information:
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21842404
Citation
Schlaug G, Marchina S, Wan CY. The use of non-invasive brain stimulation techniques to facilitate recovery from post-stroke aphasia. Neuropsychol Rev. 2011 Sep;21(3):288-301. doi: 10.1007/s11065-011-9181-y. Epub 2011 Aug 14.
Results Reference
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PubMed Identifier
23473936
Citation
Dmochowski JP, Datta A, Huang Y, Richardson JD, Bikson M, Fridriksson J, Parra LC. Targeted transcranial direct current stimulation for rehabilitation after stroke. Neuroimage. 2013 Jul 15;75:12-19. doi: 10.1016/j.neuroimage.2013.02.049. Epub 2013 Mar 5.
Results Reference
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Effects of Transcranial Direct Current Stimulation in Post-stroke Aphasia

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