RecruitingPhase 2

Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia

United States, Canada180 participantsStarted 2024-02-13

Plain-language 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.

Who can participate

Age range50 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Presence of aphasia attributable to non-fluent PPA or logopenic PPA * High school education (or more) * Between the ages of 50 and 90 * Must be able to understand the nature of the study and give informed consent Exclusion Criteria: * Cognitive impairment of sufficient severity to preclude giving informed consent (Mini Mental State Examination \[MMSE\] less than 15) * Any unrelated neurologic or physical condition that impairs communication ability * History of unrelated neurological conditions, including but not limited to traumatic brain injury (TBI), stroke, or small vessel disease, that has resulted in a neurologic deficit * Any additional neurological condition that would likely reduce the safety of study participation, including central nervous system (CNS) vasculitis, intracranial tumor, intracranial aneurysm, multiple sclerosis, or arteriovenous malformations * A medically unstable cardiopulmonary or metabolic disorder * Individuals with pacemakers or implantable cardiac defibrillators * Terminal illness associated with survival of less than 12 months * Major active psychiatric illness that may interfere with required study procedures or treatments, as determined by the enrolling physician * Current abuse of alcohol or drugs, prescription or otherwise * Participant in another drug, device, or biologics trial within 30 days prior to enrollment * Nursing a child, pregnant, or intending to become pregnant during the study * Left-handedness Exclu…

What they're measuring

Immediate Change in Phonemic Accuracy

Timeframe: Baseline and Immediate follow-up of 3-week intervention period

Immediate Change in Letter Accuracy

Timeframe: Baseline and Immediate follow-up of 3-week intervention period

Change in Phonemic Accuracy at 3-month follow-up visit

Timeframe: Baseline and 3 months post intervention

Change in Letter Accuracy at 3-month follow-up visit

Timeframe: Baseline and 3 months post intervention

Trial details

NCT IDNCT05386394

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-01

Contact for this trial

Kelly Eun, B.S.

(410) 929 - 0279 krmeun@jhmi.edu