Using brain stimulation to improve language in patients with primary progressive aphasia
Phase II Clinical Trial of Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia
PHASE2 · Johns Hopkins University · NCT05386394
This study is testing if using brain stimulation along with language therapy can help people with primary progressive aphasia improve their naming and spelling skills.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 3 sites (Baltimore, Maryland and 2 other locations) |
| Trial ID | NCT05386394 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of transcranial direct current stimulation (tDCS) combined with language therapy for patients suffering from primary progressive aphasia (PPA). The study employs a double-blind, sham-controlled, within-subject, cross-over design, where participants will receive either active tDCS or sham stimulation alongside language therapy over two treatment periods. Each treatment period lasts three weeks, with a total of 15 therapy sessions, and a wash-out period of three months between treatments to assess the effects. The goal is to determine if tDCS can enhance naming and spelling outcomes in patients with non-fluent and logopenic variants of PPA.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 to 80 with non-fluent or logopenic primary progressive aphasia who can provide informed consent.
Not a fit: Patients with severe cognitive impairment or unrelated neurological conditions that affect communication may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve communication abilities and quality of life for patients with primary progressive aphasia.
How similar studies have performed: While tDCS has shown promise in smaller studies, this is one of the first large-scale trials to rigorously test its efficacy in treating primary progressive aphasia.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Baltimore, Maryland and 2 other locations
- Johns Hopkins Hospital — Baltimore, Maryland, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- Baycrest Centre for Geriatric Care — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Kyrana Tsapkini, PhD. — Johns Hopkins University
- Study coordinator: Kelly Eun, B.S.
- Email: krmeun@jhmi.edu
- Phone: (410) 929 - 0279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Primary Progressive Aphasia, Logopenic Progressive Aphasia, Non-Fluent Primary Progressive Aphasia, transcranial direct current stimulation, language treatment, primary progressive aphasia