Remotely-supervised Neuromodulation in PPA

May 4, 2026 updated by: Maya Henry

Investigating the Benefits of Remotely-Supervised Neuromodulation In Primary Progressive Aphasia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Memory and Aging Cener
        • Contact:
        • Principal Investigator:
          • Maria Luisa Gorno-Tempini, MD, PhD
    • Texas
      • Austin, Texas, United States, 78712
        • Recruiting
        • University of Texas
        • Principal Investigator:
          • Maya L Henry, PhD
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in spoken naming
Time Frame: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
Change in percent correctly named trained/untrained pictures
change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Communication Confidence Rating Scale for Aphasia
Time Frame: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
Change on self-rating scale evaluating communication confidence in different settings for persons with aphasia. A higher score indicates greater confidence, with minimum and maximum values of 0 and 100.
change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
Change on Aphasia Impact Questionnaire
Time Frame: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
Change on patient reported outcome measure for persons with aphasia; characterizes activities, participation and emotional state/wellbeing using a 5-point pictorial rating scale. A higher score indicates greater impact of aphasia, with minimum and maximum values of 0 and 84.
change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
Theoretical Framework of Acceptability Questionnaire
Time Frame: one month after onset of treatment
The Theoretical Framework of Acceptability questionnaire is a measure developed for healthcare interventions to identify characteristics of interventions that may be improved or that were well-received.
one month after onset of treatment
Acceptability and Perception of Change Survey
Time Frame: one month after onset of treatment
The Acceptability and Perception of Change Survey characterizes perceived response to treatment.
one month after onset of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maya Henry

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Maya L Henry, PhD, University of Texas at Austin
  • Principal Investigator: Jessica D Richardson, PhD, University of New Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

October 6, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RF1AG085565 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data, including behavioral and MRI/fMRI data from 80 individuals with lvPPA and limited data from study partners, will be shared via the ICPSR repository. Data will be available at publication or within 9 months of database lock, and accessible for at least 10 years. Publicly shared datasets will exclude identifiable information, audio/video files, and non-skull-stripped imaging. Additional data may be shared via IRB-approved data-sharing agreements.

IPD Sharing Time Frame

De-identified clinical trial data (participant level and summary level data, raw and processed) will be made available at the time of publication of the primary results or within 9 months of database lock, whichever comes first. We will also include relevant datasets as supplementary material accompanying articles submitted to PubMed Central. Data will be publicly available for 10 years following the end of the award and by request thereafter.

IPD Sharing Access Criteria

De-identified data will be accessible to researchers and the broader scientific community. Publicly available datasets will be hosted on the ICPSR repository and accessible via DOI. Additional data (e.g., voice samples) may be accessed through an IRB-approved data-sharing agreement, which will require users to commit to secure data handling and non-identification of participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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