Primary Progressive AphasiaNCT05901233
Speech-Language Treatment With Remotely Supervised Transcranial Direct Current Stimulation in Primary Progressive Aphasia
A study testing Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS), Lexical Retrieval Training (LRT) and Video Implemented Script Training in Aphasia (VISTA) in people with Primary Progressive Aphasia, run by University of Texas at Austin at 2 sites in United States.
Trial summary
Primary progressive aphasia (PPA) is a disorder characterized by gradual decline in speech-language ability caused by underlying neurodegenerative disease. PPA is a devastating condition that can affect adults as young as their 50's, depriving them of the ability to communicate and function in society. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Primary Progressive Aphasia
- What is being tested?
- Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS), Lexical Retrieval Training (LRT) and Video Implemented Script Training in Aphasia (VISTA)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jul 2023to 30 Sep 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Meets diagnostic criteria for PPA
- Meets diagnostic criteria for a specific variant of PPA
- Score of 20 or higher on the Mini-Mental State Examination
- Adequate hearing and vision (with hearing or vision aids, if needed)
- Has a study partner that can co-enroll in the study and attend pre-treatment training as well as continue to be present for weekly teleconference meetings
- Able and willing to undergo MRI brain scan
- Access to high speed internet
Who cannot join
- Speech and language deficits better accounted for by another neurological disorder
- Does not meet diagnostic criteria for a specific variant of PPA
- Score of less than 20 on the Mini-Mental State Examination
- Does not have a study partner who can co-enroll in the study
- 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)
- 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
University of Texas
Austin, Texas, 78712
Memory and Aging Center, University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: Telerehabilitation With Remotely-Supervised tDCS in Progressive Aphasia
Primary progressive aphasia (PPA) is a disorder characterized by gradual decline in speech-language ability caused by underlying neurodegenerative disease. PPA is a devastating condition that can affect adults as young as their 50's, depriving them of the ability to communicate and function in society. Along with Alzheimer's Disease and other Alzheimer's Disease Related Dementias (AD/ADRD), PPA is now identified earlier and with greater precision. Increasingly, patients and families seek options for behavioral and neuromodulatory treatments to address PPA's devastating effects on communication, prolong speech-language skills, and maximize quality of life. Studies have documented the robust benefits of speech-language telerehabilitation methods for persons with PPA, with in-home treatment resulting in immediate and long-term benefits. This investigation aims to further enhance the potency of these treatment approaches by pairing them with tailored neuromodulatory intervention that targets critical brain networks supporting treatment in each clinical subtype of PPA. The study will evaluate the feasibility and preliminary benefit of home-based transcranial direct current stimulation (tDCS) combined with evidence-based speech-language telerehabilitation methods. tDCS will be delivered to patients in their own homes and site of stimulation will be tailored for each clinical subtype of PPA. This project has the potential to enhance clinical management and rehabilitation for individuals with PPA by establishing the benefit of behavioral and neuromodulatory treatment that is neurobiologically-motivated and accessible for patients and families.
- Conditions
- Primary Progressive Aphasia
- Being tested
- Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS), Remotely supervised sham tDCS (RS-sham-tDCS), Lexical Retrieval Training (LRT), Video Implemented Script Training in Aphasia (VISTA)
- Keywords
- Speech-Language Pathology, Primary Progressive Aphasia, Fronto-Temporal Dementia, Alzheimer's Disease, Neurodegenerative Disease, Logopenic, Semantic, Nonfluent, Logopenic Variant Primary Progressive Aphasia, Semantic Variant Primary Progressive Aphasia, Nonfluent Variant Primary Progressive Aphasia, Semantic Dementia, Speech Entrainment, Script Training, Teletherapy, Transcranial Direct Current Stimulation, Remotely-Supervised Transcranial Direct Current Stimulation, Lexical Retrieval, Noninvasive Brain Stimulation, Telehealth
- Medical subject headings
- Aphasia, Primary Progressive, Alzheimer Disease, Neurodegenerative Diseases, Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS)Device
tDCS is a type of non-invasive brain stimulation. 1.5 milliamp (mA) of current will be delivered via electrodes in saline-soaked sponges placed on the left side of the head and right upper arm. The stimulation will be delivered for 20 minutes, 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 sham tDCS (RS-sham-tDCS)Device
tDCS is a type of non-invasive brain stimulation. During sham stimulation 1.5 milliamp (mA) of current will be delivered for a brief period and then turned off. Current will be delivered via electrodes in saline-soaked sponges placed on the left side of the head and right upper arm. Sham will be delivered for 20 minutes, 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.
Lexical Retrieval Training (LRT)Behavioural
Participants work on producing spoken and written names of personally relevant target items using a self-cueing hierarchy. 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.
Video Implemented Script Training in Aphasia (VISTA)Behavioural
Participants work on producing personally relevant scripts of 4-6 sentences in length. Length and complexity of scripts are individually tailored. The participant completes two (one hour each) teletherapy sessions per week with a clinician targeting clear and accurate script production, script memorization, and conversational usage of scripts. The participant completes 30 minutes of independent, computer-based practice 3 times per week, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts.
| Study group | Role | What they receive |
|---|---|---|
| RS-LRT | Experimental | Not described Receives: Device: Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS); Device: Remotely supervised sham tDCS (RS-sham-tDCS); Behavioral: Lexical Retrieval Training (LRT) |
| RS-VISTA | Experimental | Not described Receives: Device: Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS); Device: Remotely supervised sham tDCS (RS-sham-tDCS); Behavioral: Video Implemented Script Training in Aphasia (VISTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
RS-LRT arm: 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)
RS-VISTA arm: Change in script production accuracy
Change in percent correct, intelligible, scripted words produced for trained/untrained scripts
Measured: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
Secondary outcomes (5)
Change on Communication Confidence Rating Scale for Aphasia
Change on 10-item Likert-type self-rating scale evaluating communication confidence in different settings for persons with aphasia. A higher score indicates greater confidence.
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.
Measured: change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)
Client Satisfaction Questionnaire
Likert-type scale measuring patient/client satisfaction with intervention. A higher score indicates greater satisfaction.
Measured: four months after treatment onset
Remotely-supervised Transcranial Direct Current Stimulation (RS-tDCS) Survey
Likert type scale used to capture participants' perceptions regarding the acceptability and potential demand for remotely-supervised tDCS.
Measured: four months after onset of treatment
Care Partner Survey
Likert-type scale used to characterize care partners' perceptions of the benefits of speech-language treatment.
Measured: four months 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 posted13 Jun 2023
- Study start10 Jul 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Progressive AphasiaStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Participants undergo 4 weeks of video-implemented script training (VISTA) or Lexical Retrieval Training (LRT) with either sham or tDCS, a 2-month washout phase, and then another 4 weeks of LRT or VISTA with the other condition (sham or tDCS). Order will be randomized.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Maya Henry, University of Texas at Austin
- Investigators
- Maya Henry, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901233
- Sponsor's protocol ID
- STUDY00002453
- Status last verified
- Oct 2025
- First submitted
- 8 May 2023
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Henry ML, Hubbard HI, Grasso SM, Mandelli ML, Wilson SM, Sathishkumar MT, Fridriksson J, Daigle W, Boxer AL, Miller BL, Gorno-Tempini ML. Retraining speech production and fluency in non-fluent/agrammatic primary progressive aphasia. Brain. 2018 Jun 1;141(6):1799-1814. doi: 10.1093/brain/awy101.
PubMed 29718131Henry 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 31390290Dial 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation With Remotely-Supervised tDCS in Progressive Aphasia
- ClinicalTrials.gov ID
- NCT05901233
- Acronym / sponsor ID
- STUDY00002453
- Conditions
- Primary Progressive Aphasia
- Keywords
- Speech-Language Pathology, Primary Progressive Aphasia, Fronto-Temporal Dementia, Alzheimer's Disease, Neurodegenerative Disease, Logopenic, Semantic, Nonfluent
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Jun 2023 (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.
Primary progressive aphasia (PPA) is a disorder characterized by gradual decline in speech-language ability caused by underlying neurodegenerative disease. PPA is a devastating condition that can affect adults as young as their 50's, depriving them of the ability to communicate and function in society. Along with Alzheimer's Disease and other Alzheimer's Disease Related Dementias (AD/ADRD), PPA is now identified earlier and with greater precision. Increasingly, patients and families seek options for behavioral and neuromodulatory treatments to address PPA's devastating effects on communication, prolong speech-language skills, and maximize quality of life. Studies have documented the robust benefits of speech-language telerehabilitation methods for persons with PPA, with in-home treatment resulting in immediate and long-term benefits. This investigation aims to further enhance the potency of these treatment approaches by pairing them with tailored neuromodulatory intervention that targets critical brain networks supporting treatment in each clinical subtype of PPA. The study will evaluate the feasibility and preliminary benefit of home-based transcranial direct current stimulation (tDCS) combined with evidence-based speech-language telerehabilitation methods. tDCS will be delivered to patients in their own homes and site of stimulation will be tailored for each clinical subtype of PPA. This project has the potential to enhance clinical management and rehabilitation for individuals with PPA by establishing the benefit of behavioral and neuromodulatory treatment that is neurobiologically-motivated and accessible for patients and families.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants undergo 4 weeks of video-implemented script training (VISTA) or Lexical Retrieval Training (LRT) with either sham or tDCS, a 2-month washout phase, and then another 4 weeks of LRT or VISTA with the other condition (sham or tDCS). Order will be randomized.
| Arm | Type | Receives |
|---|---|---|
| RS-LRT | Experimental | Device: Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS), Device: Remotely supervised sham tDCS (RS-sham-tDCS), Behavioral: Lexical Retrieval Training (LRT) |
| RS-VISTA | Experimental | Device: Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS), Device: Remotely supervised sham tDCS (RS-sham-tDCS), Behavioral: Video Implemented Script Training in Aphasia (VISTA) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Meets diagnostic criteria for PPA
- Meets diagnostic criteria for a specific variant of PPA
- Score of 20 or higher on the Mini-Mental State Examination
- Adequate hearing and vision (with hearing or vision aids, if needed)
- Has a study partner that can co-enroll in the study and attend pre-treatment training as well as continue to be present for weekly teleconference meetings
Key exclusion criteria (6 listed)
- Speech and language deficits better accounted for by another neurological disorder
- Does not meet diagnostic criteria for a specific variant of PPA
- Score of less than 20 on the Mini-Mental State Examination
- Does not have a study partner who can co-enroll in the study
- 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 |
|---|---|---|
| Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS)tDCS is a type of non-invasive brain stimulation. 1.5 milliamp (mA) of current will be delivered via electrodes in saline-soaked sponges placed on the left side of the head and right upper arm. The stimulation will be delivered for 20 minutes, 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 | RS-LRT, RS-VISTA |
| Remotely supervised sham tDCS (RS-sham-tDCS)tDCS is a type of non-invasive brain stimulation. During sham stimulation 1.5 milliamp (mA) of current will be delivered for a brief period and then turned off. Current will be delivered via electrodes in saline-soaked sponges placed on the left side of the head and right upper arm. Sham will be delivered for 20 minutes, 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 | RS-LRT, RS-VISTA |
| Lexical Retrieval Training (LRT)Participants work on producing spoken and written names of personally relevant target items using a self-cueing hierarchy. 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 | RS-LRT |
| Video Implemented Script Training in Aphasia (VISTA)Participants work on producing personally relevant scripts of 4-6 sentences in length. Length and complexity of scripts are individually tailored. The participant completes two (one hour each) teletherapy sessions per week with a clinician targeting clear and accurate script production, script memorization, and conversational usage of scripts. The participant completes 30 minutes of independent, computer-based practice 3 times per week, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts. | Behavioural | RS-VISTA |
Primary outcome
RS-LRT arm: 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
RS-VISTA arm: Change in script production accuracy
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 correct, intelligible, scripted words produced for trained/untrained scripts
5 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)
Client Satisfaction Questionnaire
Time frame: four months after treatment onset
Remotely-supervised Transcranial Direct Current Stimulation (RS-tDCS) Survey
Time frame: four months after onset of treatment
Care Partner Survey
Time frame: four months 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 8 Oct 2025.
- Background: PubMed 29718131Henry ML, Hubbard HI, Grasso SM, Mandelli ML, Wilson SM, Sathishkumar MT, Fridriksson J, Daigle W, Boxer AL, Miller BL, Gorno-Tempini ML. Retraining speech production and fluency in non-fluent/agrammatic primary progressive aphasia. Brain. 2018 Jun 1;141(6):1799-1814. doi: 10.1093/brain/awy101.
- 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.
- 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.
- University of Texas Aphasia Research and Treatment LabLink provided by the sponsor.
- UCSF Language Neurobiology LabLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 Henry, PhD principal investigator
University of Texas at Austin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remotely supervised Transcranial Direct Current Stimulation (RS-tDCS), Lexical Retrieval Training (LRT) and Video Implemented Script Training in Aphasia (VISTA) in people with Primary Progressive Aphasia, run by University of Texas at Austin 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 7 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: enrolling by invitation, as of the sponsor's last update on 8 Oct 2025. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RS-LRT arm: 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)). The study lists 2 primary outcomes in all. 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 NCT05901233, which also lists 3 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 8 Oct 2025; AzTrials last refreshed its copy on 26 Oct 2026.