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.
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
- Conditions the study is for
- Primary Progressive Aphasia(PPA), Progressive Aphasia, Progressive Aphasia in Alzheimer's Disease
- What is being tested?
- Lexical Retrieval Cascade Treatment and Remotely Supervised Transcranial Direct Current Stimulation- Active
- Type of treatment
- Medical device, Lifestyle or therapy programme
- 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.
United States2 sites, 2 recruiting
- 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
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.
- 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)
- 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 group | Role | What they receive |
|---|---|---|
| Language Therapy with Active Stimulation | Experimental | Participants 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 Stimulation | Sham comparator | Participants 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.
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)
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)
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)
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
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.
- First posted3 Dec 2025
- Study start15 Apr 2026
- Primary completion1 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Progressive Aphasia(PPA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Maya Henry
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Maya Henry, University of Texas at Austin
- Investigators
- Maya L Henry, PhD, Principal investigator, University of Texas at AustinJessica D Richardson, PhD, Principal investigator, University of New Mexico
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 30880927Henry 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Benefits of Remotely-Supervised Neuromodulation In Primary Progressive Aphasia
- ClinicalTrials.gov ID
- NCT07260253
- Acronym / sponsor ID
- RF1AG085565
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maya HenryUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into one of two arms: sham or active remotely-supervised transcranial direct current stimulation (RS-tDCS).
| Arm | Type | Receives |
|---|---|---|
| Language Therapy with Active Stimulation | Experimental | Behavioral: Lexical Retrieval Cascade Treatment, Device: Remotely Supervised Transcranial Direct Current Stimulation- ActiveParticipants will receive virtual language therapy in conjunction with active remotely-supervised transcranial direct current stimulation. |
| Language Therapy with Sham Stimulation | Sham comparator | Behavioral: Lexical Retrieval Cascade Treatment, Device: Remotely Supervised Transcranial Direct Current Stimulation - ShamParticipants will receive virtual language therapy in conjunction with sham remotely-supervised transcranial direct current stimulation. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lexical Retrieval Cascade TreatmentAlso: LRCTParticipants 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. | Behavioural | Language Therapy with Active Stimulation, Language Therapy with Sham Stimulation |
| Remotely Supervised Transcranial Direct Current Stimulation- ActivetDCS 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. | Device | Language Therapy with Active Stimulation |
| Remotely Supervised Transcranial Direct Current Stimulation - ShamtDCS 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. | Device | Language Therapy with Sham Stimulation |
Primary outcome
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
4 secondary outcomes
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 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)
Theoretical Framework of Acceptability Questionnaire
Time frame: one month after onset of treatment
Acceptability and Perception of Change Survey
Time frame: one month after onset of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 30880927Dial 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.
- Background: PubMed 31390290Henry 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.
- University of Texas Aphasia Research and Treatment LabLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maya L Henry, PhD principal investigator
University of Texas at Austin
Jessica D Richardson, PhD principal investigator
University of New Mexico
2 sites in 1 country: see every site and its status.
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.