tDCS + Speech-Language Therapy for Aphasia

Overseen By Kyrana Tsapkini, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Stroke, Neurological disorder, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 1-3 weeks

Trial Summary

What is the purpose of this trial?

Primary progressive aphasia (PPA) is a neurodegenerative disease that affects first and foremost language abilities. There are three different variants of PPA, each a relatively distinct speech and language profile. For individuals with non-fluent variant PPA (nfvPPA), a core symptom is apraxia of speech (AOS), which is defined as an oral motor speech disorder. Such a disorder inhibits one's ability to translate speech plans into motor plans and results in longer segmental durations and reduced rate of syllabic production. This research project investigates the behavioral and neuromodulatory effects of transcranial direct current stimulation (tDCS) during language therapy in participants with nfvPPA over time. Anodal tDCS targeting the left inferior frontal gyrus (IFG) administered in combination with language therapy is expected to be more beneficial when compared to language therapy alone (sham). The investigators believe tDCS during language therapy will 1) improve language performance or decrease rate of decline, 2) promote better-sustained effects at 2 weeks and 2 months post-treatment, and 3) produce generalization to untrained language items and some other cognitive functions. Resting-state fMRI, diffusion tensor imaging (DTI), and volumetric data are also collected to investigate changes in functional brain connectivity associated with tDCS in individuals with PPA. A better understanding of the therapeutic and neuromodulatory mechanisms of tDCS as an adjunct to language therapy in nfvPPA may have a significant impact on the development of effective therapies for PPA, and may offer insight into ways of impeding neurodegeneration that may improve patients' quality of life, as well as extend patients' ability to work and manage patients' affairs.

Research Team

Kyrana Tsapkini, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for right-handed English speakers with at least a 9th grade education, diagnosed with non-fluent variant primary progressive aphasia (nfvPPA) or unclassifiable PPA. Participants must be able to follow directions and not have severe language impairment, other neurological disorders, other language-based learning disorders, or uncorrected visual/hearing impairments.

Inclusion Criteria

Must have at least 9th grade education.

I have been diagnosed with a specific type of language disorder based on tests and MRI.

Must be speaker of English.

Exclusion Criteria

I can follow directions for basic tasks.

Your ability to speak and understand language is severely impaired, as shown by a specific test score.

You have not corrected your vision or hearing problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) combined with language therapy, with 10-15 sessions over 1-3 weeks, followed by a 2-month interval before crossover to the other condition.

1-3 weeks

10-15 sessions (in-person)

Follow-up

Participants are monitored for sustained effects of the treatment at 2-week and 2-month intervals post-treatment.

2 months

2 visits (in-person)

Imaging

Imaging assessments are conducted before and after each treatment phase and at follow-up intervals to evaluate changes in brain connectivity.

Throughout the study

Up to 8 imaging sessions

Treatment Details

Interventions

• tDCS

Trial Overview The study tests if brain stimulation called transcranial direct current stimulation (tDCS), when combined with speech-language therapy, helps people with nfvPPA speak better than just therapy alone. It looks at immediate improvements in language performance and checks if these benefits last up to two months after treatment.

Participant Groups

Group I: Active tDCS plus Speech-Language Therapy first Experimental Treatment 2 Interventions

Active tDCS will be applied at the beginning of 45 minutes speech-language therapy session and then participant will be switched to sham tDCS after a washout period.

Group II: Sham plus Speech-Language Therapy first Placebo Group 2 Interventions

Sham will be applied at the beginning of 45 minutes speech-language therapy session and then participant will be switched to an active tDCS after a washout period.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+