Status:
RECRUITING
Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Primary Progressive Aphasia
Logopenic Progressive Aphasia
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
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 techn...
Detailed Description
Aim 1: To determine whether tDCS over the left perisylvian language areas paired with naming treatment will improve oral and written naming outcomes in two variants of PPA (nfvPPA and lvPPA). The inv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05386394
Start Date
February 13 2024
End Date
February 1 2028
Last Update
September 9 2025
Active Locations (3)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
3
Baycrest Centre for Geriatric Care
Toronto, Ontario, Canada, M6A 2E1