Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia

Description

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

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Study Overview

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Study Details

Study overview

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.

Phase II Clinical Trial of Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia

Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia

Condition
Primary Progressive Aphasia
Intervention / Treatment

-

Contacts and Locations

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Cognitive impairment of sufficient severity to preclude giving informed consent (Mini Mental State Examination \[MMSE\] less than 15 or Montreal Cognitive Assessment \[MOCA\] less than 10; Frontotemporal Dementia - Modified Clinical Dementia Rating \[FTD-CDR\] Scale score =3)
  • * Any unrelated neurologic of 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 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 intent to become pregnant during the study
  • * Left-handedness
  • * 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
  • * 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, claustrophobic, metal in eye or orbit, tattooed eyeliner

Ages Eligible for Study

50 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Johns Hopkins University,

Kyrana Tsapkini, PhD., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2028-02-01