RecruitingPhase 2NCT05386394

Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia

Phase II Clinical Trial of Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia


Sponsor

Johns Hopkins University

Enrollment

180 participants

Start Date

Feb 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

While many have strongly suggested that transcranial direct current stimulation (tDCS) may represent a beneficial intervention for patients with primary progressive aphasia (PPA), this promising technology has not yet been applied widely in clinical settings. This treatment gap is underscored by the absence of any neurally-focused standard-of-care treatments to mitigate the devastating impact of aphasia on patients' family, work, and social lives. Given that tDCS is inexpensive, easy to use (it is potentially amenable to home use by patients and caregivers), minimally invasive, and safe there is great promise to advance this intervention toward clinical use. The principal reason that tDCS has not found wide clinical application yet is that its efficacy has not been tested in large, multi-center, clinical trials. In this study, scientists in the three sites that have conducted tDCS clinical trials in North America-Johns Hopkins University and the University of Pennsylvania in the US, and the University of Toronto in Canada, will collaborate to conduct a multi-site, Phase II clinical trial of tDCS a population in dire need of better treatments.


Eligibility

Min Age: 50 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Active tDCS + Language Therapy and a medical device called Sham tDCS + Language Therapy for people with logopenic progressive aphasia, non-fluent primary progressive aphasia, and other related conditions. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 50 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive tDCS + Language Therapy

Active tDCS stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 milliamps (mA)/cm2; estimated total charge 0.048 Coulombs (C)/cm2) in a ramp-like fashion for a maximum of 20 minutes. Language therapy will be conducted in conjunction with stimulation and will target oral and written naming.

DEVICESham tDCS + Language Therapy

During sham stimulation, current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Language therapy targeting oral and written naming will be administered during sham tDCS stimulation.


Locations(3)

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Baycrest Centre for Geriatric Care

Toronto, Ontario, Canada

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NCT05386394


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