Recruiting

Phase 2

Transcranial Direct Current StimulationTranscranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia

Sponsor:

Johns Hopkins University

Code:

NCT05386394

Conditions

Primary Progressive Aphasia

Logopenic Progressive Aphasia

Non-Fluent Primary Progressive Aphasia

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Active tDCS + Language Therapy

Sham tDCS + Language Therapy

Study Details

Brief 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.

Conditions

Primary Progressive Aphasia

Logopenic Progressive Aphasia

Non-Fluent Primary Progressive Aphasia

Study ID

NCT05386394

Start date

Feb 13, 2024

Status verified date

Apr, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

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

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

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active tDCS + Language Therapy first

Active tDCS will be applied at the beginning of 45 minutes language therapy session and will last for 20 minutes.

sham comparator: Sham tDCS + Language Therapy first

Sham tDCS will be applied at the beginning of 45 minutes language therapy session.

Interventions

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.

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.

Primary outcome measure

Immediate Change in Phonemic Accuracy [ Time Frame: Baseline and Immediate follow-up of 3-week intervention period ]
Immediate Change in Letter Accuracy [ Time Frame: Baseline and Immediate follow-up of 3-week intervention period ]
Change in Phonemic Accuracy at 3-month follow-up visit [ Time Frame: Baseline and 3 months post intervention ]
Change in Letter Accuracy at 3-month follow-up visit [ Time Frame: Baseline and 3 months post intervention ]

Central Contacts and Locations

Central contacts

Kelly Eun, B.S.

(410) 929 - 0279 krmeun@jhmi.edu

Kyrana Tsapkini, PhD.

410-736-2940 tsapkini@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Kyrana Tsapkini, PhD

410-736-2940 tsapkini@jhmi.edu

Principal Investigator:

Kyrana Tsapkini, PhD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Daniela Sacchetti, MS

215-573-8485 danielas@pennmedicine.upenn.edu

Principal Investigator:

Roy Hamilton, PhD

Baycrest Centre for Geriatric Care

Recruiting

Toronto, Ontario, Canada, M6A 2E1

Contacts

Howard Chertkow, PhD

416-785-2500 hchertkow@research.baycrest.org

Principal Investigator:

Howard Chertkow, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

transcranial direct current stimulation
language treatment
primary progressive aphasia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-05-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.