Remotely-supervised Neuromodulation in PPA

NCT07260253 | Recruiting DMC

• 1 other identifier: RF1AG085565
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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)

Keywords

lvPPA; PPA; logopenic variant PPA; transcranial direct-current stimulation; tDCS; neuromodulation; speech therapy; speech-language pathology; logopenic; teletherapy; remote; virtual

Outcome Measures

Primary Outcomes (1)

• Change in spoken naming

  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 Outcomes (4)

• Change on Communication Confidence Rating Scale for Aphasia

  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

  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

  one month after onset of treatment

• Acceptability and Perception of Change Survey

  one month after onset of treatment

Study Arms (2)

Language Therapy with Active Stimulation

EXPERIMENTAL

Participants will receive virtual language therapy in conjunction with active remotely-supervised transcranial direct current stimulation.

Behavioral: Lexical Retrieval Cascade Treatment; Device: Remotely Supervised Transcranial Direct Current Stimulation- Active

Language Therapy with Sham Stimulation

SHAM COMPARATOR

Participants will receive virtual language therapy in conjunction with sham remotely-supervised transcranial direct current stimulation.

Behavioral: Lexical Retrieval Cascade Treatment; Device: Remotely Supervised Transcranial Direct Current Stimulation - Sham

Interventions

Lexical Retrieval Cascade Treatment BEHAVIORAL

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.

Also known as: LRCT

Language Therapy with Active Stimulation; Language Therapy with Sham Stimulation

Remotely Supervised Transcranial Direct Current Stimulation- Active DEVICE

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.

Language Therapy with Active Stimulation

Remotely Supervised Transcranial Direct Current Stimulation - Sham DEVICE

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.

Language Therapy with Sham Stimulation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Maya Henry: lead

Study Sites (2)

UCSF Memory and Aging Cener

San Francisco, California, 94158, United States

RECRUITING

University of Texas

Austin, Texas, 78712, United States

RECRUITING

Related Publications (2)

• Dial HR, Hinshelwood HA, Grasso SM, Hubbard HI, Gorno-Tempini ML, Henry ML. Investigating the utility of teletherapy in individuals with primary progressive aphasia. Clin Interv Aging. 2019 Feb 25;14:453-471. doi: 10.2147/CIA.S178878. eCollection 2019.

  PMID: 30880927 BACKGROUND

• Henry ML, Hubbard HI, Grasso SM, Dial HR, Beeson PM, Miller BL, Gorno-Tempini ML. Treatment for Word Retrieval in Semantic and Logopenic Variants of Primary Progressive Aphasia: Immediate and Long-Term Outcomes. J Speech Lang Hear Res. 2019 Aug 15;62(8):2723-2749. doi: 10.1044/2018_JSLHR-L-18-0144. Epub 2019 Aug 7.

  PMID: 31390290 BACKGROUND

Related Links

• University of Texas Aphasia Research and Treatment Lab

MeSH Terms

Conditions

Aphasia, Primary Progressive; Aphasia; Communication Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Speech Disorders; Language Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Neurodevelopmental Disorders

Study Officials

• Maya L Henry, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Jessica D Richardson, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aphasia Lab Research Coordinator

CONTACT

512-471-3420; aphasialab@austin.utexas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Associate Dean for Research

Model Details: Participants will be randomized into one of two arms: sham or active remotely-supervised transcranial direct current stimulation (RS-tDCS).

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: December 3, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (2)