NCT06649084

Brief Summary

The goal of this clinical trial is to learn if a speech-language telerehabilitation helps improve communication in people with primary progressive aphasia (PPA), a form of dementia that affects speech and language. The study will also document how acceptable and helpful the program is for both patients and their care partners. The main questions the study aims to answer are:

  • Take part in online speech-language therapy sessions
  • Complete communication tasks and questionnaires before and after the program
  • Have regular virtual check-ins with the research team
  • Include their care partners in some parts of the program for training and support

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 8, 2025

Status Verified

September 1, 2025

Enrollment Period

2.7 years

First QC Date

October 16, 2024

Last Update Submit

October 5, 2025

Conditions

Keywords

Speech-Language PathologyNeurodegenerative DiseaseLogopenicSemanticNonfluentSpeech EntrainmentTelethearpyMultimodal Communication TrainingPartner TrainingAugmentative and Alternative CommunicationScript training

Outcome Measures

Primary Outcomes (4)

  • Change in script production accuracy

    Percent correct intelligible, scripted words for trained/untrained scripts

    change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment

  • Change in spoken naming of trained/untrained items

    Percent correctly named trained/untrained pictures

    change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment

  • Information communicated in any modality for trained/untrained stimuli

    Percent of major content units (key words) communicated via speech or nonspeech modalities (e.g., writing, drawing, gesture) for trained/untrained scripts (Multi-VISTA) or words (Multi-LRT) during structured probes and in conversation

    change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment

  • Goal Attainment Score

    The Goal Attainment Score is self-reported progress on personalized goals based on a five point scale.

    change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment

Secondary Outcomes (2)

  • Change on Quick Aphasia Battery

    change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment

  • Change on Aphasia Impact Questionnaire

    change from pre-treatment to post-treatment (approximately 6-12 weeks after treatment onset) and follow-ups at 3 months post-treatment

Other Outcomes (1)

  • Post-treatment Communication Survey

    post-treatment (approximately 6-12 weeks after treatment onset)

Study Arms (3)

Multicomponent Lexical Retrieval Training (Multi-LRT)

EXPERIMENTAL
Behavioral: Multicomponent Lexical Retrieval Training (Multi-LRT)

Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA)

EXPERIMENTAL
Behavioral: Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA)

Experimental: Multicomponent Communicaiton Partner Training (Multi-CPT)

EXPERIMENTAL
Behavioral: Multicomponent Communication Partner Training (Multi-CPT)

Interventions

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 target in multiple communication modalities. Treatment focuses on the use of strategies which capitalize on residual linguistic ability and autobiographical memory to support word retrieval. The participant completes two one-hour-long sessions per week plus daily homework. The participant also meets 4 times during the course of treatment with a study partner (e.g., spouse) for communication counseling, education, and practice of communication strategies.

Multicomponent Lexical Retrieval Training (Multi-LRT)

In person or via teletherapy: A multi-component treatment incorporating elements of restitutive, compensatory, and care-partner focused interventions. Participants work on producing personally relevant scripts of 3-5 sentences in length. Length and complexity of scripts are individually tailored. The participant completes 30 minutes per day of home practice, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts. Biweekly (one hour each) sessions with a clinician are held which target clear and accurate script production, script memorization, and conversational usage of the script and multimodal communication. The participant also meets 6 times during the course of treatment with a study partner (e.g., spouse) for communication counseling, education, and practice of communication strategies.

Multicomponent Video Implemented Script Training in Aphasia (Multi-VISTA)

In person or via teletherapy: A multi-component treatment incorporating elements of compensatory and care-partner focused interventions. Biweekly (one hour each) sessions with a clinician are held which target use of communication strategies including multimodal communication for the participant and study partner (e.g., spouse). The participant also completes regular assignments meant to increase generalization of communication strategies and progress on personal goals.

Experimental: Multicomponent Communicaiton Partner Training (Multi-CPT)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Meets diagnostic criteria for Primary Progressive Aphasia (PPA; Gorno-Tempini et al., 2011)
  • Scores of 10 or higher on the Mini-Mental State Examination
  • Has a study partner who can consistently attend sessions

You may not qualify if:

  • Other neurological or psychiatric diagnosis that may contribute to cognitive-linguistic deficits
  • Significant, uncorrected visual or hearing impairment that would interfere with participation
  • Score of less than 10 on the Mini-Mental State Examination
  • Prominent initial non-speech-language impairment (cognitive, behavioral, motoric)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Aphasia, Primary ProgressiveFrontotemporal DementiaMemory DisordersPrimary 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 18, 2024

Study Start

May 2, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

October 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations