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Primary Progressive Aphasia(PPA)NCT07260253

Remotely-supervised Neuromodulation in PPA

A study testing Lexical Retrieval Cascade Treatment and Remotely Supervised Transcranial Direct Current Stimulation- Active in people with Primary Progressive Aphasia(PPA) and Progressive Aphasia, run by Maya Henry at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Lexical Retrieval Cascade Treatment and Remotely Supervised Transcranial Direct Current Stimulation- Active
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
2 sitesUnited States
Study dates
15 Apr 2026to 30 Apr 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meets diagnostic criteria for primary progressive aphasia (PPA)
  • Meets diagnostic criteria for logopenic variant PPA
  • Attains score of 15 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

Who cannot join

  • Speech and language deficits better accounted for by another neurological disorder
  • Does not meet diagnostic criteria for logopenic variant PPA
  • Scores less than 15 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Aphasia Lab Research Coordinator contact

512-471-3420

aphasialab@austin.utexas.edu

United States2 sites, 2 recruiting
  • University of Texas

    Austin, Texas, 78712

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

    Maya L Henry, PhD

    Recruiting
  • UCSF Memory and Aging Cener

    San Francisco, California, 94158

    Willa Keegan-Rodewald, M.A., willa.keeganrodewald@ucsf.edu

    Maria Luisa Gorno-Tempini, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: 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:

Read more
  • 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.
Being tested
Lexical Retrieval Cascade Treatment, Remotely Supervised Transcranial Direct Current Stimulation- Active, Remotely Supervised Transcranial Direct Current Stimulation - Sham
Keywords
lvPPA, PPA, logopenic variant PPA, transcranial direct-current stimulation, tDCS, neuromodulation, speech therapy, speech-language pathology, logopenic, teletherapy, remote, virtual
Medical subject headings
Aphasia, Primary Progressive, Aphasia, Communication Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lexical Retrieval Cascade TreatmentBehavioural

    Also called LRCT

    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.

  • Remotely Supervised Transcranial Direct Current Stimulation- ActiveDevice

    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.

  • Remotely Supervised Transcranial Direct Current Stimulation - ShamDevice

    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.

Study groups in NCT07260253
Study groupRoleWhat they receive
Language Therapy with Active StimulationExperimentalParticipants will receive virtual language therapy in conjunction with active remotely-supervised transcranial direct current stimulation.
Receives: Behavioral: Lexical Retrieval Cascade Treatment; Device: Remotely Supervised Transcranial Direct Current Stimulation- Active
Language Therapy with Sham StimulationSham comparatorParticipants will receive virtual language therapy in conjunction with sham remotely-supervised transcranial direct current stimulation.
Receives: Behavioral: Lexical Retrieval Cascade Treatment; Device: Remotely Supervised Transcranial Direct Current Stimulation - Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in spoken naming

    Change in percent correctly named trained/untrained pictures

    Measured: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)

Secondary outcomes (4)
  1. Change on Communication Confidence Rating Scale for Aphasia

    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.

    Measured: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)

  2. Change on Aphasia Impact Questionnaire

    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.

    Measured: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)

  3. Theoretical Framework of Acceptability Questionnaire

    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.

    Measured: one month after onset of treatment

  4. Acceptability and Perception of Change Survey

    The Acceptability and Perception of Change Survey characterizes perceived response to treatment.

    Measured: one month after onset of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start15 Apr 2026
  3. Primary completion1 Apr 2030 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized into one of two arms: sham or active remotely-supervised transcranial direct current stimulation (RS-tDCS).
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07260253
Sponsor's protocol ID
RF1AG085565
Other IDs
RF1AG085565
Status last verified
Apr 2026
First submitted
6 Oct 2025
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 30880927
  • 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.

    PubMed 31390290

Questions about this trial

What is this clinical trial studying?

A study testing Lexical Retrieval Cascade Treatment and Remotely Supervised Transcranial Direct Current Stimulation- Active in people with Primary Progressive Aphasia(PPA) and Progressive Aphasia, run by Maya Henry at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aphasia Lab Research Coordinator (512-471-3420, aphasialab@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07260253, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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