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NCT Number: NCT04432883

Targeted TDCS 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.

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Key information

Conditions

Stroke Aphasia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Vascular Diseases

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico Center for Brain Recovery and Repair

Albuquerque, New Mexico, 87106, United States

Location status: Recruiting

Location contact

Darbi Gill

CONTACT

[email protected]

505-925-4043

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 25-85
  • 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)
  • pregnancy

Treatment and study plan

Active Comparator: Experimental: Active cathodal tDCS + language training

Device

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: Placebo cathodal tDCS + Speech and language

Behavioral

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

Primary outcomes

  1. Picture Naming of trained items

    Time frame: 3 months

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

  2. 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)

  3. 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

  1. Discourse informativeness - Main Concept Production

    Time frame: 3 months

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

  2. Efficiency of discourse informativeness - Main Concept Production

    Time frame: 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

  3. Picture Naming of untrained items - Boston Naming Test

    Time frame: 3 months

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

  4. Naming Response Time of untrained items - Boston Naming Test

    Time frame: 3 months

    Change in response time of naming of pictures of untrained items; 0-20 seconds, decreased response time indicates improvement

  5. Naming Efficiency of untrained items - Boston Naming Test

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Honey Hubbard

CONTACT

[email protected]

505-433-7766

Jessica Richardson, Ph.D.

CONTACT

[email protected]

505 277-1765

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: AphasiatDCS

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2020
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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