Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT05386394
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT05386394
Study Brief:
Protocol Section:
NCT05386394