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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04432883
Acronym
AphasiatDCS
Enrollment
50
Registered
2020-06-16
Start date
2022-10-18
Completion date
2027-04-30
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Stroke

Keywords

Stroke, Aphasia, brain stimulation, communication problems, speech and language therapy

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

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.

BEHAVIORALSham Comparator: Placebo cathodal tDCS + Speech and language

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 85 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Picture Naming of trained items3 monthsChange 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 monthsChange 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 items3 monthsChange in efficiency of naming of pictures of trained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency

Secondary

MeasureTime frameDescription
Discourse informativeness - Main Concept Production3 monthsChange in discourse informativeness as measured by main concept scores; increased values indicate improvement
Efficiency of discourse informativeness - Main Concept Production3 monthsChange 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 Test3 monthsChange in naming of pictures of untrained items; 60 pictured items; higher score indicates improvement
Naming Response Time of untrained items - Boston Naming Test3 monthsChange 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 Test3 monthsChange in efficiency of naming of pictures of untrained items; median response time divided by proportion correct naming; smaller numbers indicate greater efficiency

Countries

United States

Contacts

CONTACTJessica Richardson, Ph.D.
jdrichardson@unm.edu505 277-1765
CONTACTHoney Hubbard
hhubbard@unm.edu505-433-7766
PRINCIPAL_INVESTIGATORJessica Richardson, Ph.D.

University of New Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026