Targeted TDCS to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Comparator: Experimental: Active cathodal tDCS + language training, Sham Comparator: Placebo cathodal tDCS + Speech and language.
- Who it may be relevant to
- Registry conditions: Stroke, Aphasia. Basic parameters: 25 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Targeted Transcranial Direct Current Stimulation to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia
Overview
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
- 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. .
Primary outcome measures
- Picture Naming of trained items [Time frame: 3 months]
- Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008) [Time frame: 3 months]
- Naming Efficiency of trained items [Time frame: 3 months]
Secondary outcome measures (5)
- Discourse informativeness - Main Concept Production [Time frame: 3 months]
- Efficiency of discourse informativeness - Main Concept Production [Time frame: 3 months]
- Picture Naming of untrained items - Boston Naming Test [Time frame: 3 months]
- Naming Response Time of untrained items - Boston Naming Test [Time frame: 3 months]
- Naming Efficiency of untrained items - Boston Naming Test [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of New Mexico Center for Brain Recovery and Repair — Albuquerque
Identifiers
NCT: NCT04432883 · UNM HRRC #16-091 · 1P20GM109089-01A1 · R01DC018282