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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Aphasia
• Intervention / Treatment: Device: Active Comparator: Experimental: Active cathodal tDCS + language training; Behavioral: Sham Comparator: Placebo cathodal tDCS + Speech and language

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Richardson, Ph.D.; Phone Number: 505 277-1765; Email: jdrichardson@unm.edu
• Study Contact Backup: Name: Honey Hubbard; Phone Number: 505-433-7766; Email: hhubbard@unm.edu

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Recruiting
      • University of New Mexico Center for Brain Recovery and Repair
      • Contact: Darbi Gill; Phone Number: 505-925-4043; Email: DMGill@salud.unm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental: Active cathodal tDCS + Speech-language training; In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of active tDCS (x 30 minutes of stimulation) combined with 1 hour simultaneous speech-language training on consecutive weekdays.	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.; Other Names: Behavioral: Speech and Language Training
Sham Comparator: Comparator: Placebo cathodal tDCS + Speech-language training; In this arm, 31 patients with stroke induced Aphasia will undergo 15 sessions of sham tDCS (x 30 minutes sham) combined with 1 hour simultaneous speech-language training on consecutive weekdays..	Behavioral: Sham Comparator: Placebo cathodal tDCS + Speech and language; Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Picture Naming of trained items	Change in naming of pictures of trained items; 60 pictured items; higher score indicates improvement	3 months
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discourse informativeness - Main Concept Production	Change in discourse informativeness as measured by main concept scores; increased values indicate improvement	3 months
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
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
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
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

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: National Institutes of Health (NIH); National Institute of General Medical Sciences (NIGMS); National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Jessica Richardson, Ph.D., University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2022
• Primary Completion (Estimated): March 26, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Aphasia; brain stimulation; communication problems; speech and language therapy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Language Disorders; Speech Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Aphasia; Communication Disorders; Therapeutics; Patient Care; Rehabilitation; Aftercare; Continuity of Patient Care; Rehabilitation of Speech and Language Disorders; Language Therapy
• Other Study ID Numbers: UNM HRRC #16-091; 1P20GM109089-01A1 (U.S. NIH Grant/Contract); R01DC018282 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes