Targeted TDCS to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia.

Not Applicable

Recruiting

• Conditions: Aphasia; Stroke

• Registration Number: NCT04432883
• Lead Sponsor: University of New Mexico

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

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Study Start: 2022-10-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-02
• Primary Completion: 2027-03-26
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. aged 25-85
2. must be greater than 6 months post-stroke
3. must have a diagnosis of aphasia based on impaired performance on the Western Aphasia Battery-Revised, Boston Naming Test, or during discourse production
4. must be left-hemisphere dominant as demonstrated by aphasia onset subsequent to left hemisphere damage
5. must be stimulable for naming

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Picture Naming of trained items	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)	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	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 Outcome Measures

Name	Time	Method
Discourse informativeness - Main Concept Production	3 months	Change in discourse informativeness as measured by main concept scores; increased values indicate improvement
Efficiency of discourse informativeness - Main Concept Production	3 months	Change in efficiency of discourse informativeness; accurate and complete main concepts produced over the time of discourse elicitation (ACs/min); larger numbers indicate greater efficiency
Picture Naming of untrained items - Boston Naming Test	3 months	Change in naming of pictures of untrained items; 60 pictured items; higher score indicates improvement
Naming Response Time of untrained items - Boston Naming Test	3 months	Change in response time of naming of pictures of untrained items; 0-20 seconds, decreased response time indicates improvement
Naming Efficiency of untrained items - Boston Naming Test	3 months	Change in efficiency of naming of pictures of untrained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency

Trial Locations

Locations (1)

University of New Mexico Center for Brain Recovery and Repair; 🇺🇸 Albuquerque, New Mexico, United States