Speech-Language Treatment With Remotely Supervised Transcranial Direct Current Stimulation in Primary Progressive Aphasia

NCT05901233 | Enrolling By Invitation FDA Device

• 1 other identifier: STUDY00002453
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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. 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

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

Outcome Measures

Primary Outcomes (2)

• RS-LRT arm: 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)

• RS-VISTA arm: Change in script production accuracy

  Change in percent correct, intelligible, scripted words produced for trained/untrained scripts

  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 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)

• Client Satisfaction Questionnaire

  four months after treatment onset

• Remotely-supervised Transcranial Direct Current Stimulation (RS-tDCS) Survey

  four months after onset of treatment

• Care Partner Survey

  four months after onset of treatment

Study Arms (2)

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)

Interventions

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.

RS-LRT; RS-VISTA

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.

RS-LRT; RS-VISTA

Lexical Retrieval Training (LRT) 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.

RS-LRT

Video Implemented Script Training in Aphasia (VISTA) BEHAVIORAL

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.

RS-VISTA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• University of California, San Francisco: collaborator

Study Sites (2)

Memory and Aging Center, University of California, San Francisco

San Francisco, California, 94158, United States

Location

University of Texas

Austin, Texas, 78712, United States

Location

Related Publications (3)

• 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.

  PMID: 29718131 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

• 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

Related Links

• University of Texas Aphasia Research and Treatment Lab
• UCSF Language Neurobiology Lab

MeSH Terms

Conditions

Aphasia, Primary Progressive; Alzheimer Disease; Neurodegenerative Diseases; Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Tauopathies; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Maya Henry, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The order of administration for active and sham stimulation phases will be masked for the participant, study partner, study clinician, and primary investigator.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Speech, Language and Hearing Sciences

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 13, 2023
• Study Start: July 10, 2023
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)