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

July 25, 2023 updated by: Maya Henry, University of Texas at Austin

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Memory and Aging Center, University of California, San Francisco
    • Texas
      • Austin, Texas, United States, 78712
        • University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Because PPA is a rare disease, the study aims to recruit all eligible participants with PPA who are referred to the Aphasia Research and Treatment Lab at the University of Texas (UT) Austin, the UT/Dell Medical School Department of Neurology, and the University of California at San Francisco (UCSF) Memory and Aging Center, as well as individuals with PPA from other clinical and research sites. The study will aim to include males, females, and transgender or non-binary individuals. Great efforts will be made to recruit participants from minority populations, subject to the limitation that participants need to be fluent speakers of English.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RS-LRT
Device: 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: 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.
Behavioral: 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.
Experimental: RS-VISTA
Device: 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: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
change from pre-treatment to one month and three months after onset of treatment in each phase (stimulation and sham)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 10-item Likert-type self-rating scale evaluating communication confidence in different settings for persons with aphasia. A higher score indicates greater confidence.
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)
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.
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
Likert-type scale measuring patient/client satisfaction with intervention. A higher score indicates greater satisfaction.
four months after treatment onset
Remotely-supervised Transcranial Direct Current Stimulation (RS-tDCS) Survey
Time Frame: four months after onset of treatment
Likert type scale used to capture participants' perceptions regarding the acceptability and potential demand for remotely-supervised tDCS.
four months after onset of treatment
Care Partner Survey
Time Frame: four months after onset of treatment
Likert-type scale used to characterize care partners' perceptions of the benefits of speech-language treatment.
four months after onset of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Collaborators

University of California, San Francisco

Investigators

  • Principal Investigator: Maya Henry, PhD, University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002453

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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