tDCS + Language Therapy for Primary Progressive Aphasia

Phase 2

Recruiting

Led By Kyrana Tsapkini, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between the ages of 50 and 80

Presence of aphasia attributable to non-fluent PPA or logopenic PPA

Must not have

History of spontaneous or partial complex seizures or unexplained loss of consciousness within 6 months of enrollment (exclusion for tDCS)

Cognitive impairment of sufficient severity to preclude giving informed consent (Mini Mental State Examination [MMSE] less than 15 or Montreal Cognitive Assessment [MOCA] less than 10; Frontotemporal Dementia - Modified Clinical Dementia Rating [FTD-CDR] Scale score =3)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediate follow-up of 3-week intervention period and 3-month follow-up

Summary

This trial will test the feasibility and effectiveness of tDCS in people with primary progressive aphasia.

Who is the study for?

This trial is for individuals aged 50-80 with non-fluent or logopenic primary progressive aphasia (PPA), who have at least a high school education and can consent to the study. Excluded are those with recent participation in other trials, left-handedness, pregnancy, severe cardiopulmonary disorders, pacemakers, terminal illness, major psychiatric issues that affect study compliance, previous skull breaches, certain MRI exclusions like claustrophobia or metal implants near the eye.

What is being tested?

The trial tests transcranial direct current stimulation (tDCS) combined with language therapy against a sham tDCS plus language therapy to see if it helps PPA patients. It's a Phase II multi-center clinical trial conducted by Johns Hopkins University, University of Pennsylvania and University of Toronto.

What are the potential side effects?

tDCS is generally considered safe but may cause mild side effects such as tingling on the scalp where electrodes are placed, fatigue after treatment sessions or slight itching under electrode pads during stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 50 and 80 years old.

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I have speech difficulties due to specific brain conditions.

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I understand the study and can agree to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had unexplained fainting or complex seizures in the last 6 months.

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I am able to understand and consent to medical procedures (my cognitive tests show I'm capable).

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I have a serious heart, lung, or metabolic condition.

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I have never had surgery on my skull.

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I do not have any serious brain or nerve conditions that could make the study unsafe for me.

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I have had a brain condition like a stroke or injury that affects my brain function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediate follow-up of 3-week intervention period and 3-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediate follow-up of 3-week intervention period and 3-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate follow-up of 3-week intervention period and 3-month follow-up for reporting.