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

Stroke Clinical Trial

— AphasiatDCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04432883
• Other study ID #: UNM HRRC #16-091
• Secondary ID: 1P20GM109089-01A
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2024
• Source: University of New Mexico
• Contact: Jessica Richardson, Ph.D.
• Phone: 505 277-1765
• Email: jdrichardson[@]unm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2026
• Est. primary completion date: December 8, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 85 Years

Eligibility

Inclusion Criteria:

1. aged 25-85

2. must be greater than 1 year 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

Related Conditions & MeSH terms

• Aphasia
• Stroke

Intervention

Device:
• Active Comparator: Experimental: Active cathodal tDCS + language training
Cathodal tDCS raises neuronal membrane potentials, leading to decreased probability of depolarization from incoming stimuli. Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment.

Behavioral:
• Sham Comparator: Placebo cathodal tDCS + Speech and language
Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. .

Locations

Country	Name	City	State
United States	University of New Mexico Center for Brain Recovery and Repair	Albuquerque	New Mexico

Sponsors (4)

Lead Sponsor	Collaborator
University of New Mexico	National Institute of General Medical Sciences (NIGMS), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Picture Naming of trained items	Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement	3 months
Primary	Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)	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)	3 months
Primary	Naming Efficiency of trained items	Change in efficiency of naming of pictures of trained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency	3 months
Secondary	Discourse informativeness - Main Concept Production	Change in discourse informativeness as measured by main concept scores; increased values indicate improvement	3 months
Secondary	Efficiency of discourse informativeness - Main Concept Production	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	3 months
Secondary	Picture Naming of untrained items - Boston Naming Test	Change in naming of pictures of untrained items; 60 pictured items; higher score indicates improvement	3 months
Secondary	Naming Response Time of untrained items - Boston Naming Test	Change in response time of naming of pictures of untrained items; 0-20 seconds, decreased response time indicates improvement	3 months
Secondary	Naming Efficiency of untrained items - Boston Naming Test	Change in efficiency of naming of pictures of untrained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency	3 months