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Clinical Trials/NCT06649084
NCT06649084
Enrolling By Invitation
Not Applicable

Establishing Evidence-based Multicomponent Treatment for Speech and Language in Primary Progressive Aphasia

University of Texas at Austin1 site in 1 country21 target enrollmentMay 2, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Primary Progressive Aphasia
Sponsor
University of Texas at Austin
Enrollment
21
Locations
1
Primary Endpoint
Change in script production accuracy
Status
Enrolling By Invitation
Last Updated
6 months ago

Overview

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:

  1. Is the telerehabilitation program feasible and acceptable for people with PPA and their care partners?
  2. Do participants with PPA and care partners report satisfaction with the program?
  3. Which outcome measures are most useful for evaluating changes in communication and quality of life?
  4. What patterns of treatment response are seen in participants after completing the program?

Researchers will test the program in a small group of participants to see how people respond. The program includes both speech-language therapy and training for care partners.

Participants will:

  • 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
Registry
clinicaltrials.gov
Start Date
May 2, 2023
End Date
December 31, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maya Henry

Associate Professor

University of Texas at Austin

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Change in script production accuracy

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

Percent correct intelligible, scripted words for trained/untrained scripts

Change in spoken naming of trained/untrained items

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

Percent correctly named trained/untrained pictures

Information communicated in any modality for trained/untrained stimuli

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

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

Goal Attainment Score

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

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

Secondary Outcomes

  • 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)

Study Sites (1)

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