Remotely-supervised Neuromodulation in PPA

Purpose

The goal of this clinical trial is to learn whether home-based brain stimulation combined with virtual speech-language therapy can improve communication abilities in adults with logopenic variant primary progressive aphasia (lvPPA), a language disorder most often caused by Alzheimer's disease. The main questions the study aims to answer are: - Is combining remotely supervised transcranial direct current stimulation (tDCS) with virtual speech-language therapy feasible and acceptable for people with lvPPA? - Does this combined treatment lead to improvements in communication compared to speech-language therapy with sham (placebo) stimulation? - Do individual brain characteristics help predict who benefits most from this treatment? Researchers will compare participants who receive active tDCS plus virtual speech-language therapy to participants who receive sham (placebo) tDCS plus virtual speech-language therapy to see if active brain stimulation enhances communication outcomes. Participants will: - Complete speech-language therapy sessions delivered by video visit. - Receive either active or sham tDCS that is remotely supervised and completed at home. - Complete language and cognitive testing before and after treatment. - Undergo brain imaging and other assessments to help understand treatment response.

Conditions

  • Primary Progressive Aphasia(PPA)
  • Progressive Aphasia
  • Progressive Aphasia in Alzheimer's Disease
  • Logopenic Progressive Aphasia (LPA)
  • Logopenic Variant Primary Progressive Aphasia
  • Logopenic Variant of Primary Progressive Aphasia (LPA)

Eligibility

Eligible Ages
Over 40 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Meets diagnostic criteria for primary progressive aphasia (PPA) - Meets diagnostic criteria for logopenic variant PPA - Attains score of 20 or higher on the Mini-Mental State Examination - Has adequate hearing and vision (with hearing or vision aids, if needed) - Is able to travel to research site and undergo MRI brain scan - Has access to high speed internet and basic experience using a computer and the internet - Is a fluent speaker of English - Has a study partner who can co-enroll in the study, attend pre-treatment training at the research site, and be present for teleconference meetings, as needed

Exclusion Criteria

  • Speech and language deficits better accounted for by another neurological disorder - Does not meet diagnostic criteria for logopenic variant PPA - Scores less than 20 on the Mini-Mental State Examination - Does not have a study partner who can co-enroll in the study - Has contraindications for tDCS or MRI scan (History of seizures, head injury, craniotomy, skull surgery or fracture; History of severe or frequent migraines; Metallic implant in head or any metal in head; Pacemaker or cardioverter-defibrillator or any other stimulator; Chronic skin problems; Pregnancy) - Has a history of stroke, epilepsy, or significant brain injury

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants will be randomized into one of two arms: sham or active remotely-supervised transcranial direct current stimulation (RS-tDCS).
Primary Purpose
Treatment
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Language Therapy with Active Stimulation 		Participants will receive virtual language therapy in conjunction with active remotely-supervised transcranial direct current stimulation.
  • Behavioral: Lexical Retrieval Cascade Treatment
    Participants work on producing spoken and written names of personally-relevant target items. Treatment focuses on the use of strategies that capitalize on spared cognitive-linguistic abilities to support word retrieval. The participant completes two (one hour each) teletherapy sessions per week with a clinician plus 30 minutes of additional independent, computer-based practice exercises 3 times per week.
    Other names:
    • LRCT
  • Device: Remotely Supervised Transcranial Direct Current Stimulation- Active
    tDCS is a type of non-invasive brain stimulation. 2.0 milliamp (mA) of current will be delivered via electrodes in saline-soaked sponges placed on the left and right sides of the head. The stimulation will last 20 minutes and will occur 5 times weekly, in the participant's home setting, while the participant engages in computer-delivered speech-language training. Sessions are monitored by study personnel.
Sham Comparator
Language Therapy with Sham Stimulation 		Participants will receive virtual language therapy in conjunction with sham remotely-supervised transcranial direct current stimulation.
  • Behavioral: Lexical Retrieval Cascade Treatment
    Participants work on producing spoken and written names of personally-relevant target items. Treatment focuses on the use of strategies that capitalize on spared cognitive-linguistic abilities to support word retrieval. The participant completes two (one hour each) teletherapy sessions per week with a clinician plus 30 minutes of additional independent, computer-based practice exercises 3 times per week.
    Other names:
    • LRCT
  • Device: Remotely Supervised Transcranial Direct Current Stimulation - Sham
    tDCS is a type of non-invasive brain stimulation. 2.0 milliamp (mA) of current will be delivered via electrodes in saline-soaked sponges placed on the left and right sides of the head. In sham stimulation, current will be delivered for a brief period of time and then turned off. Sham stimulation will last 20 minutes and will occur 5 times weekly, in the participant's home setting, while the participant engages in computer-delivered speech-language training. Sessions are monitored by study personnel.

Recruiting Locations

UCSF Memory and Aging Cener
San Francisco, California 94158
Contact:
Willa Keegan-Rodewald, M.A.
willa.keeganrodewald@ucsf.edu

University of Texas
Austin, Texas 78712
Contact:
Aphasia Lab Research Coordinator, MS
512-471-3420
aphasialab@austin.utexas.edu

More Details

Status
Recruiting
Sponsor
Maya Henry

Study Contact

Aphasia Lab Research Coordinator
512-471-3420
aphasialab@austin.utexas.edu