RECRUITING

Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia

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Conditions

Primary Progressive AphasiaLogopenic Progressive AphasiaNon-Fluent Primary Progressive Aphasiatranscranial direct current stimulationlanguage treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-02-13
Study Completion:2028-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05386394

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.

Ages Eligible for Study:50 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Presence of aphasia attributable to non-fluent PPA or logopenic PPA
  2. * High school education (or more)
  3. * Between the ages of 50 and 80
  4. * Must be able to understand the nature of the study and give informed consent
  1. * 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)
  2. * Any unrelated neurologic of physical condition that impairs communication ability
  3. * 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
  4. * 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
  5. * A medically unstable cardiopulmonary or metabolic disorder
  6. * Individuals with pacemakers or implantable cardiac defibrillators
  7. * Terminal illness associated with survival of less than 12 months
  8. * Major active psychiatric illness that may interfere with required study procedures or treatments, as determined by enrolling physician
  9. * Current abuse of alcohol or drugs, prescription or otherwise
  10. * Participant in another drug, device or biologics trial within 30 days prior to enrollment
  11. * Nursing a child, pregnant or intent to become pregnant during the study
  12. * Left-handedness
  13. * History of spontaneous or partial complex seizures or unexplained loss of consciousness within 6 months of enrollment
  14. * Subjects with metallic objects in the face or head other than dental apparatus, such as braces, fillings or implants
  15. * Subjects with previous craniotomy or any breach in the skull
  16. * 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)
  17. * Presence of any of the following: pregnancy, claustrophobic, metal in eye or orbit, tattooed eyeliner

Contacts and Locations

Study Contact

Margaret Li
CONTACT
410 929 - 2079
mli164@jh.edu
Kyrana Tsapkini, PhD.
CONTACT
410-736-2940
tsapkini@jhmi.edu

Principal Investigator

Kyrana Tsapkini, PhD.
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Kyrana Tsapkini, PhD., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-13
Study Completion Date2028-02-01

Study Record Updates

Study Start Date2024-02-13
Study Completion Date2028-02-01

Terms related to this study

Keywords Provided by Researchers

  • transcranial direct current stimulation
  • language treatment
  • primary progressive aphasia

Additional Relevant MeSH Terms

  • Primary Progressive Aphasia
  • Logopenic Progressive Aphasia
  • Non-Fluent Primary Progressive Aphasia