Communication Bridge 3 Study

Primary Progressive Aphasia Clinical Trial

— CB3  

Official title:

Communication Bridge: Optimizing an Evidence-based Intervention for Individuals With Primary Progressive Aphasia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06191198
• Other study ID #: IRB23-1175
• Secondary ID: 7R01AG055425-07
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 15, 2024
• Est. completion date: September 2028

Study information

• Verified date: June 2024
• Source: University of Chicago
• Contact: Matthew Bona, MPH
• Phone: 773-702-1220
• Email: cbtrial[@]uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild-moderate Primary Progressive Aphasia (PPA). The aim of the study is to help us better understand the effects of speech-language therapy on communication abilities in individuals with PPA.

Description:

Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for approximately 17 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive up to 10 evaluations and 20 speech therapy sessions with a licensed speech therapist, as well as access to Communication Bridge, a personalized web application to practice home exercises that reinforce treatment strategies. There are no costs to participate in this study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: September 2028
• Est. primary completion date: September 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria (person with PPA):

1. Meets diagnostic criteria for PPA based on neurologist and supporting medical assessments (extracted from medical records)

2. English as primary language used in daily communication activities (by self-report)

3. Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)

4. Adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report)

5. Able to pass technology screening and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)

6. Geriatric Depression Scale score = 9

7. Mild-moderate PPA informed by a structured interview with a speech-language pathologist and a standardized testing battery.

Inclusion Criteria (Co-enrolled communication partner):

1. 18+ years of age

2. English as primary language used in daily communication activities (by self-report)

3. Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)

4. Able to pass technology screening* and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)

Exclusion Criteria:

• A dementia diagnosis other than Primary Progressive Aphasia

• Participation is co-enrolled in an outside speech language therapy program during the study course.

• Communication partners will be excluded if they have a pre-existing communication impairment that would affect study participation (e.g., aphasia, dementia)

Medical records will be requested and reviewed to determine eligibility

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Pick Disease of the Brain
• Primary Progressive Aphasia

Intervention

Behavioral:
• Communication Bridge™
Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
• Evidence-Based Impairment Focused
Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.

Locations

Country	Name	City	State
United States	University of Chicago - American School Building	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	National Institute on Aging (NIA), Western University, Canada

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Communication Participation Person Centered Goals	Goal Attainment Scaling, a 7-point rating scale with -3 representing 'no longer participating' and +3 representing 'exceeded goal'. Higher scores indicate better progress in goal achievement.	5 assessment time points through study completion, an average of 1 year, including change over time