Clinical trial NCT04432883: Targeted TDCS to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia.
Official title: Targeted Transcranial Direct Current Stimulation to Enhance Speech-Language Treatment Outcome in Persons With Chronic Post-Stroke Aphasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Aphasia
Keywords: Stroke
Aphasia
brain stimulation
communication problems
speech and language therapy
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2020-06-16
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Picture Naming of trained items
timeFrame: 3 months
measure: Naming Response Time of trained items Scales - IV (WAIS-IV; Wechsler, Coalson, & Railford, 2008)
timeFrame: 3 months
measure: Naming Efficiency of trained items
timeFrame: 3 months
Secondary outcomes:
measure: Discourse informativeness - Main Concept Production
timeFrame: 3 months
measure: Efficiency of discourse informativeness - Main Concept Production
timeFrame: 3 months
measure: Picture Naming of untrained items - Boston Naming Test
timeFrame: 3 months
measure: Naming Response Time of untrained items - Boston Naming Test
timeFrame: 3 months
measure: Naming Efficiency of untrained items - Boston Naming Test
timeFrame: 3 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Center for Brain Recovery and Repair
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Jessica Richardson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: