ClinicalTrials.gov
ClinicalTrials.gov Menu

Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03371706
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : April 4, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Emily Rogalski, Northwestern University

Brief Summary:

This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild 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.

Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for 12 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive 5 evaluations and 15 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 and compensation will be provided.


Condition or disease Intervention/treatment Phase
Primary Progressive Aphasia Behavioral: Evidence-Based Treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Communication Bridge: A Person-centered Internet-based Intervention for Individuals With Primary Progressive Aphasia
Estimated Study Start Date : April 3, 2018
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2024


Arm Intervention/treatment
Experimental: Evidence-Based Treatment 1 Behavioral: Evidence-Based Treatment
Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
Active Comparator: Evidence-Based Treatment 2 Behavioral: Evidence-Based Treatment
Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.



Primary Outcome Measures :
  1. Language Performance Measures [ Time Frame: 5 times over the course of the year ]
    Accuracy on word training and script training.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of PPA (with mild impairment)
  • Communication partner (e.g. spouse, family member) who is willing to participate
  • Adequate experience with computers and sufficient Internet connection
  • English speaking

Exclusion Criteria:

  • A dementia diagnosis other than Primary Progressive Aphasia
  • Participation in outside speech language therapy during the course of the 1-year study

Medical records will be requested and reviewed by the study doctors to determine eligibility. Additionally, a technology screening will be administered to determine comfort level with computers.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371706


Contacts
Contact: Marie E Saxon, M.S. 312-503-4012 marie.saxon@northwestern.edu
Contact: Emily Rogalski, Ph.D. 312-503-1155 e-rogalski@northwestern.edu

Locations
United States, Illinois
Cognitive Neurology and Alzheimer's Disease Center - Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Marie Saxon, M.S.    312-503-4012    marie.saxon@northwestern.edu   
Contact: Emily Rogalski, Ph.D.    312-503-1155    erogalski@gmail.com   
Principal Investigator: Emily Rogalski, Ph.D.         
Sponsors and Collaborators
Northwestern University
National Institute on Aging (NIA)
Investigators
Principal Investigator: Emily Rogalski, Ph.D. Northwestern University

Responsible Party: Emily Rogalski, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03371706     History of Changes
Other Study ID Numbers: STU00206086
1R01AG055425-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emily Rogalski, Northwestern University:
aphasia
primary progressive aphasia
dementia
communication
frontotemporal dementia
Alzheimer's disease

Additional relevant MeSH terms:
Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases