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New treatment option for Primary Progressive Aphasia
Official title Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia
ClinicalTrials.gov ID: NCT05386394
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 90. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- Any additional neurological condition that would likely reduce the safety of study participation, including central nervous system (CNS) vasculitis...
- A medically unstable cardiopulmonary or metabolic disorder
- Individuals with pacemakers or implantable cardiac defibrillators
See the full eligibility 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
- 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...
- 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
- people with metallic objects in the face or head other than dental apparatus, such as braces, fillings, or implants
- people 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...
- Presence of any of the following: pregnancy, claustrophobia, metal in eye or orbit, tattooed eyeliner
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Philadelphia, Pennsylvania, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Philadelphia, Pennsylvania, United States; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.