NCT07219680

Brief Summary

The goal of this clinical trial is to learn whether a personalized, multi-component, virtual speech language treatment program can improve communication and quality of life for adults with primary progressive aphasia (PPA) and their primary communication partners. The study will enroll participants who speak English and/or Spanish. The main questions the study aims to answer are:

  • Is the telerehabilitation program feasible and acceptable for people with PPA and their study partners?
  • Do participants with PPA and study partners find treatment beneficial?
  • What patterns of treatment response are seen in participants?
  • Which outcome measures are most useful for evaluating changes in communication and quality of life? Researchers will compare participants who receive intervention immediately to participants assigned to a waitlist control group (who will receive treatment after a delay) to see whether participation in the treatment program is associated with improvements in communication and quality of life. Participants will:
  • Take part in speech language therapy sessions delivered by video visit that combine restorative, compensatory, and partner-focused communication strategies. Treatment may take place after a waiting period.
  • Receive education and communication training together with their partner.
  • Complete speech, language, and cognitive assessments.
  • Complete questionnaires about communication abilities, daily functioning, and quality of life.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
15mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Aug 2027

First Submitted

Initial submission to the registry

October 20, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

October 20, 2025

Last Update Submit

April 15, 2026

Conditions

Keywords

speech-language pathologyneurodegenerative diseaselogopenicnonfluentsemanticscript trainingteletherapyremotemultimodal communication trainingpartner trainingaugmentative and alternative communicationAACCommunication BookbilingualSpanishHispanicLatino

Outcome Measures

Primary Outcomes (4)

  • Change in spoken naming of trained/untrained items

    Percent correctly named trained/untrained pictures

    change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment

  • Change in script production accuracy

    Percent correct intelligible, scripted words for trained/untrained scripts

    change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment

  • Change in barriers and facilitators in dyad conversation

    Number of conversation barriers and facilitators observed in conversation

    change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment

  • Communication Modality Inventory

    A likert-type survey characterizing frequency and type of communication modalities used in conversation, administered to both the person with PPA and their conversation partner.

    change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment

Secondary Outcomes (5)

  • Change on Quick Aphasia Battery

    change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment

  • Change on Aphasia Impact Questionnaire

    change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment

  • Acceptability and Perception of Change Survey

    post-treatment (approximately 12-13 weeks after treatment onset)

  • Change on Adult Carers Quality of Life Questionnaire

    change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment

  • Change on Brief - Coping Orientation to Problems Experienced Inventory (Brief-COPE)

    change from pre-treatment or waitlist to post-treatment or waitlist (12-13 weeks), and follow-up at 3 months post-treatment

Study Arms (2)

Waitlist Control

OTHER

Individuals in the waitlist-control group will undergo initial assessment followed by a waiting interval of 12 (Multi-VISTA) or 13 (Multi-LRCT) weeks. Following the waiting period, they will again complete baseline assessments prior to the treatment phase (co-development of training materials and Multi-VISTA or Multi-LRCT treatment).

Behavioral: Multicomponent Lexical Retrieval Cascade TrainingBehavioral: Multicomponent Video Implemented Script Training in Aphasia

Immediate Treatment

EXPERIMENTAL

Individuals in the immediate treatment group will undergo initial assessment followed immediately by the treatment phase (co-development of training materials and Multi-VISTA or Multi-LRCT treatment).

Behavioral: Multicomponent Lexical Retrieval Cascade TrainingBehavioral: Multicomponent Video Implemented Script Training in Aphasia

Interventions

In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions. Treatment focuses on production of individually-tailored, personally relevant scripts. The participant completes 30 minutes per day of independent practice, during which they speak in unison with a video model. Biweekly (45-90 minute) sessions with a clinician target clear and accurate script production, memorization, and conversational usage, as well as multimodal communication. The participant meets six times during the course of treatment with a study partner (e.g., spouse) for communication counseling, education, and practice of communication strategies.

Also known as: Multi-VISTA
Immediate TreatmentWaitlist Control

In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions. Participants work on producing names of personally relevant targets in multiple communication modalities. Biweekly (45-90 minute) sessions with a clinician target multimodal communication and the use of strategies to support word retrieval. These skills are also trained via daily independent practice. The participant meets six times during the course of treatment with a study partner (e.g., spouse) for communication counseling, education, and practice of communication strategies.

Also known as: Multi-LRCT
Immediate TreatmentWaitlist Control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A PPA (Gorno-Tempini et al., 2011) or "PPA-plus" (Mesulam et al., 2001) diagnosis
  • MMSE score of 15 or higher and must be able to produce single monosyllabic words intelligibly
  • Must speak English, Spanish or both languages (i.e., bilingual speakers of English or Spanish)
  • Hearing and vision adequate for participation in teleconference meetings
  • Must have a study partner available (someone who will commit to attending teleconference sessions, as needed, during assessment and treatment phases)
  • Partners must express willingness to attend and participate in assessment and treatment sessions, including those targeting dyadic communication goals
  • Partners must speak English, Spanish or both languages (i.e., bilingual speakers of English or Spanish)
  • Partner's hearing and vision should be adequate for participation in teleconference meetings
  • The participant and/or study partner must have basic experience using a computer.

You may not qualify if:

  • Other central nervous system or medical diagnosis that can account for symptoms
  • Psychiatric diagnosis that can account for symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas

Austin, Texas, 78712, United States

RECRUITING

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: 29718131BACKGROUND
  • 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: 31390290BACKGROUND
  • 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: 30880927BACKGROUND

Related Links

MeSH Terms

Conditions

Aphasia, Primary ProgressiveFrontotemporal DementiaPrimary Progressive Nonfluent AphasiaAphasiaNeurodegenerative Diseases

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersFrontotemporal Lobar DegenerationTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Maya L Henry, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR
  • Stephanie M Grasso, PhD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry Lab Research Coordinator

CONTACT

Grasso Lab Research Coordinator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants in Arm 1, the immediate treatment group, will proceed immediately to initial assessments followed by the treatment phase (co-development of training materials and Multi-VISTA or Multi-LRCT treatment). Participants in Arm 2, the waitlist control group, will undergo initial assessment followed by a waiting interval of 12 (Multi-VISTA) or 13 (Multi-LRCT) weeks. Following the waiting period, they will be reassessed for cognitive-linguistic and participant-reported outcome measures prior to the treatment phase (co-development of training materials and Multi-VISTA or Multi-LRCT treatment).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Associate Dean for Research

Study Record Dates

First Submitted

October 20, 2025

First Posted

October 22, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations