Transcranial Direct Current Stimulation in the Treatment of Primary Progressive Aphasia

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05386394
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Active tDCS + Language Therapy — DEVICE
    Active tDCS stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 milliamps (mA)/cm2; estimated total charge 0.048 Coulombs (C)/cm2) in a ramp-like fashion for a maximum of 20 minutes. Language therapy will be conducted in conjunction with stimulation and will target oral and written naming.
  • Sham tDCS + Language Therapy — DEVICE
    During sham stimulation, current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Language therapy targeting oral and written naming will be administered during sham tDCS stimulation.

Study Details

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.

Key Dates

Start date
Feb 13, 2024
Status verified
Apr 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Active tDCS + Language Therapy first
    Active tDCS will be applied at the beginning of 45 minutes language therapy session and will last for 20 minutes.
  • Sham Comparator: Sham tDCS + Language Therapy first
    Sham tDCS will be applied at the beginning of 45 minutes language therapy session.

Primary Outcome Measure

Immediate Change in Phonemic Accuracy [ Time Frame: Baseline and Immediate follow-up of 3-week intervention period ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287
Kyrana Tsapkini, PhD
[email protected]
410-736-2940
Kyrana Tsapkini, PhD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Daniela Sacchetti, MS
[email protected]
215-573-8485
Roy Hamilton, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins Hospital· Baltimore, MDUniversity of Pennsylvania· Philadelphia, PA

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