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

University of New Mexico (UNM)

Status: Enrolling

Conditions: Stroke; Aphasia

Treatments: Behavioral: Sham Comparator: Placebo cathodal tDCS + Speech and language; Device: Active Comparator: Experimental: Active cathodal tDCS + language training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04432883

R01DC018282 (U.S. NIH Grant/Contract)

UNM HRRC #16-091

1P20GM109089-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 25 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Experimental: Active cathodal tDCS + Speech-language training

Active Comparator group

Description:

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.

Treatment:

Device: Active Comparator: Experimental: Active cathodal tDCS + language training

Comparator: Placebo cathodal tDCS + Speech-language training

Sham Comparator group

Description:

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..

Treatment:

Behavioral: Sham Comparator: Placebo cathodal tDCS + Speech and language