Remotely-supervised Neuromodulation in PPA

NCT ID: NCT07260253

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2029-08-31

Brief Summary

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The goal of this clinical trial is to learn whether remotely-supervised transcranial direct-current stimulation (RS-tDCS) can improve speech and language treatments for individuals with logopenic variant primary progressive aphasia (lvPPA). tDCS is a form of brain stimulation where a low-level electrical current is delivered to the brain through electrodes placed on the head.

The main questions the trial aims to answer are:

* Is it feasible to do RS-tDCS with virtual speech therapy?
* How can brain magnetic resonance imaging scans (MRIs) predict how well someone will benefit from RS-tDCS with virtual speech therapy?

Researchers will compare active RS-tDCS stimulation to sham stimulation (where there is no active stimulation, but participants feel stimulation effects at the beginning and end of the session).

Participants will:

* Travel to either the University of California, San Francisco (UCSF) or the University of Texas at Austin (UT Austin) one time for in-person testing, an MRI scan, and training on how to use the RS-tDCS equipment
* Meet with a speech-language pathologist for pre-treatment testing on Zoom for 2 weeks
* Participate in speech-language therapy and independent practice on Zoom 5 days a week for 4 weeks, using either active tDCS stimulation or sham
* Complete post-treatment testing on Zoom for 1-2 weeks
* Complete follow-up testing 2 months after completion of treatment

Detailed Description

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Conditions

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Language Therapy with Active Stimulation

Transcranial direct current stimulation (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 and right sides of the head. The stimulation will be delivered for 20 minutes, 5 times weekly, in the participant's home setting while the participant engages in virtual speech-language training. Sessions are monitored by study personnel.

Group Type EXPERIMENTAL

Lexical Retrieval Cascade Treatment

Intervention Type BEHAVIORAL

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.

Remotely Supervised Transcranial Direct Current Stimulation

Intervention Type 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 and right sides of the head. During sham stimulation 1.5 milliamp (mA) of current will be delivered for a brief period and then turned off. 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.

Language Therapy with Sham Stimulation

Transcranial direct current stimulation (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 and right sides of the head. Sham will be delivered for 20 minutes, 5 times weekly, in the participant's home setting while the participant engages in virtual speech-language training. Sessions are monitored by study personnel.

Group Type SHAM_COMPARATOR

Lexical Retrieval Cascade Treatment

Intervention Type BEHAVIORAL

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.

Remotely Supervised Transcranial Direct Current Stimulation

Intervention Type 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 and right sides of the head. During sham stimulation 1.5 milliamp (mA) of current will be delivered for a brief period and then turned off. 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.

Interventions

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Lexical Retrieval Cascade Treatment

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.

Intervention Type BEHAVIORAL

Remotely Supervised Transcranial Direct Current Stimulation

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 and right sides of the head. During sham stimulation 1.5 milliamp (mA) of current will be delivered for a brief period and then turned off. 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.

Intervention Type DEVICE

Other Intervention Names

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LRCT

Eligibility Criteria

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Inclusion Criteria

* Meets diagnostic criteria for primary progressive aphasia (PPA)
* Meets diagnostic criteria for logopenic variant 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 teleconference meetings, as needed
* Able and willing to undergo MRI brain scan
* Access to high speed internet and basic experience using a computer and the internet
* Individuals should be fluent speakers of English

Exclusion Criteria

* Speech and language deficits better accounted for by another neurological disorder
* Does not meet diagnostic criteria for logopenic variant 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maya L Henry, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

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UCSF Memory and Aging Cener

San Francisco, California, United States

Site Status RECRUITING

University of Texas

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aphasia Lab Research Coordinator

Role: CONTACT

Phone: 512-471-3420

Email: [email protected]

Facility Contacts

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Willa Keegan-Rodewald, M.A.

Role: primary

Aphasia Lab Research Coordinator, MS

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30880927 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31390290 (View on PubMed)

Related Links

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https://slhs.utexas.edu/research/aphasia-research-treatment-lab

University of Texas Aphasia Research and Treatment Lab

Other Identifiers

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RF1AG085565

Identifier Type: NIH

Identifier Source: secondary_id

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RF1AG085565

Identifier Type: NIH

Identifier Source: org_study_id

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