CClinicalTrials.gg
RecruitingNCT04432883AphasiatDCSUpdated May 22, 2026

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

An interventional study of Active Comparator: Experimental: Active cathodal tDCS + language training and Sham Comparator: Placebo cathodal tDCS + Speech and language in Stroke and Aphasia, sponsored by University of New Mexico. Recruiting at 1 site in United States. Open to participants aged 25 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University of New Mexico · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
25 Years to 85 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Stroke
  • Aphasia

Keywords

  • Stroke
  • Aphasia
  • brain stimulation
  • communication problems
  • speech and language therapy
03

Who can participate

Ages eligible
25 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • DeviceActive 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.

    Also known as: Behavioral: Speech and Language Training

  • BehavioralSham Comparator: Placebo cathodal tDCS + Speech and language

    Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. .

05

What researchers measure

Primary outcomes

  1. Picture Naming of trained items

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

    Time frame: 3 months

  2. 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)

    Time frame: 3 months

  3. 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

    Time frame: 3 months

Secondary outcomes

  1. Discourse informativeness - Main Concept Production

    Change in discourse informativeness as measured by main concept scores; increased values indicate improvement

    Time frame: 3 months

  2. 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

    Time frame: 3 months

  3. Picture Naming of untrained items - Boston Naming Test

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

    Time frame: 3 months

  4. 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

    Time frame: 3 months

  5. 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

    Time frame: 3 months

06

Study locations

1 of 1 sites recruiting
  • University of New Mexico Center for Brain Recovery and Repair
    Albuquerque, New Mexico 87106, United States
    Recruiting
07

References and documents

Study documents

  • Informed consent form · Jul 12, 2022

Documents are hosted by the registry — open the source record to download them.

08

Registry details

Key details

Study ID
NCT04432883
Lead 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)
Responsible party
Jessica Richardson (Assistant Professor: SOM Neurosurgery, University of New Mexico) — Principal investigator
First posted
Jun 16, 2020
Start date
Oct 18, 2022
Primary completion
Mar 26, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
May 22, 2026

Study contacts

Jessica Richardson, Ph.D.
Contact
jdrichardson@unm.edu
505 277-1765
Honey Hubbard
Contact
hhubbard@unm.edu
505-433-7766
Jessica Richardson, Ph.D.
principal investigator · University of New Mexico

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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