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RECRUITING

NCT05386394

PHASE2

Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2024-02-13

Completion Date

2028-02-01

Last Updated

2025-09-09

Healthy Volunteers

Yes

Conditions

Primary Progressive Aphasia Logopenic Progressive Aphasia Non-Fluent Primary Progressive Aphasia

Interventions

DEVICE

Active 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.

DEVICE

Sham 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.

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

Locations (3)

Johns Hopkins Hospital

Baltimore, Maryland, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Baycrest Centre for Geriatric Care

Toronto, Ontario, Canada