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Clinical Trials/NCT04432883
NCT04432883
Recruiting
Not Applicable

Targeted Transcranial Direct Current Stimulation to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia

University of New Mexico1 site in 1 country50 target enrollmentOctober 18, 2022
ConditionsStrokeAphasia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University of New Mexico
Enrollment
50
Locations
1
Primary Endpoint
Picture Naming of trained items
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

62 patients who are one year post stroke and have Aphasia as a result of that stroke will be recruited. Participants will have 4 assessment sessions and 15 treatment sessions. The TDCS will be to right Inferior Frontal Gyrus (IFG) (25 active, 25 sham) for 15 days. A combined semantic feature analysis/phonological components analysis treatment will be paired with the stimulation. Two assessment sessions will be pretreatment, 1 session immediately post-treatment, and 1 session at 3 months follow-up.

Detailed Description

Our long-term goal is to develop safe and effective treatments for the communication problems of Aphasia due to stroke that restore patients to higher levels of functioning, decrease disability, and promote higher quality of life. While language therapy for aphasia is effective, improvements are typically slow, and gains may be small. Noninvasive brain stimulation has been suggested as a method to enhance outcomes from language therapy. This study will examine whether outcomes for language therapy with brain stimulation are different from outcomes for language therapy without brain stimulation in people with aphasia. Our central hypotheses are (1) targeted right hemisphere HDtDCS (RH-HD-tDCS) administered in combination with language treatment will result in greater changes in naming accuracy than language treatment with the sham RH-HD-tDCS (2) RH-HD-tDCS plus language treatment will result in greater increases in communication within the affected hemisphere compared to language treatment plus sham RH-HD-tDCS (3) RH-HD-tDCS plus language treatment will result in greater increases in perilesional areas working together immediately post-treatment compared to language treatment plus sham RH-HD-tDCS

Registry
clinicaltrials.gov
Start Date
October 18, 2022
End Date
April 30, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jessica Richardson

Assistant Professor: SOM Neurosurgery

University of New Mexico

Eligibility Criteria

Inclusion Criteria

  • must be greater than 6 months post-stroke
  • must have a diagnosis of aphasia based on impaired performance on the Western Aphasia Battery-Revised, Boston Naming Test, or during discourse production
  • must be left-hemisphere dominant as demonstrated by aphasia onset subsequent to left hemisphere damage
  • must be stimulable for naming

Exclusion Criteria

  • comorbid neurological disease.
  • damage to the anterior right hemisphere.
  • significant mood disorder.
  • substance/alcohol dependence or abuse within the past year
  • presence of any implanted electrical device or contraindications to tDCS or MRI
  • recent medical instability (within 4 weeks)

Outcomes

Primary Outcomes

Picture Naming of trained items

Time Frame: 3 months

Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement

Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)

Time Frame: 3 months

Change in response time of naming of pictures of trained items; 0-20 seconds, decreased response time indicates improvement Scales - IV (WAIS-IV; Wechsler, Coalson, \& Railford, 2008)

Naming Efficiency of trained items

Time Frame: 3 months

Change in efficiency of naming of pictures of trained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency

Secondary Outcomes

  • Discourse informativeness - Main Concept Production(3 months)
  • Efficiency of discourse informativeness - Main Concept Production(3 months)
  • Picture Naming of untrained items - Boston Naming Test(3 months)
  • Naming Response Time of untrained items - Boston Naming Test(3 months)
  • Naming Efficiency of untrained items - Boston Naming Test(3 months)

Study Sites (1)

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