NCT05386394 · Phase 2 · RECRUITING
Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia
This trial is testing whether transcranial direct current stimulation (tDCS) — a mild electrical current applied to the scalp — combined with language therapy helps people with primary progressive aphasia (PPA) more than language therapy alone with a sham (inactive) device. It is a Phase 2 trial, meaning researchers are testing whether it actually works and is safe, not a proven or approved treatment. The study runs across Johns Hopkins, University of Pennsylvania, and University of Toronto.
Eligibility criteria
Inclusion Criteria: * Presence of aphasia attributable to non-fluent PPA or logopenic PPA * High school education (or more) * Between the ages of 50 and 80 * 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 Exclusion for tDCS, specifically: * History of spontaneous or partial complex seizures or unexplained loss of consciousness within 6 months of enrollment * Subjects with metallic objects in the face or head other than dental apparatus, such as braces, fillings, or implants * Subjects with previous craniotomy or any breach in the skull Exclusion for MRI, specifically: * Presence of any of the following devices: cardiac pacemaker, other pacemakers (for carotid sinus, insulin pumps, nerve stimulators, lead wires or similar wires), optic implant, implanted cardiac defibrillator, aneurysm clip, any electronically/magnetically/mechanically activated implant, ferromagnetic implants (coils, filters, stents; metal sutures or staples) * Presence of any of the following: pregnancy, claustrophobia, metal in eye or orbit, tattooed eyeliner
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-09-09