Using Augmentative & Alternative Communication to Promote Language Recovery for People With Post-Stroke Aphasia
NAIL
A Preliminary Study of the Neurobiology of AAC-Induced Language Recovery in Post-Stroke Aphasia
1 other identifier
interventional
20
1 country
1
Brief Summary
The currently available interventions only partially restore language abilities in patients with post-stroke aphasia; preventing successful reintegration into society. This study will increase our knowledge of how we can use assistive technology interventions to help people with aphasia restore language function. Further, this project will help us identify regions of the brain responsible for these changes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
1 active site
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 Start
First participant enrolled
September 1, 2018
CompletedFirst Submitted
Initial submission to the registry
September 4, 2019
CompletedFirst Posted
Study publicly available on registry
September 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedSeptember 9, 2019
September 1, 2019
2.9 years
September 4, 2019
September 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Western Aphasia Battery-Revised Aphasia Quotient
a diagnostic tool used to determine aphasia type and severity
3 years
Visual Regions of Interest Activation intensity
A functional magnetic resonance imaging (fMRI) measure to indicate change in brain involvement during resting state and language tasks.
3 years
Connectivity Indices
Connectivity indices reflect the temporal correlation between canonical language and visual regions of interest during language and resting state fMRI tasks.
3 years
Secondary Outcomes (8)
Motor-Free Visual Perception Test-4
3 years
Discourse Analyses
3years
Communication analyses
3 years
Stroke and Aphasia Quality of Life-39 (SAQOL-39)
3 years
Communication Effectiveness Index (CETI)
3 years
- +3 more secondary outcomes
Study Arms (1)
AAC-LaRc
EXPERIMENTALall participants receive the experimental treatment
Interventions
iPads will be programmed with a personalized communication application (app) and a structured 4-step intervention will be employed to instruct patients how to cue themselves during anomic events via pictures, text, or speak buttons.
Eligibility Criteria
You may qualify if:
- at least 18 years old
- native speaker of american English
- compatible for 3 Tesla MRI
- Ischemic, left middle cerebral artery stroke
- at least 12 months post stroke
- pass hearing screening
- pass vision screening
- diagnosis of aphasia on the Western Aphasia Bedside Screen
- ability to produce 5-10 intelligible words
- no more than a moderate apraxia of speech or dysarthria
- minimal or no AAC/iPad experience
- written consent by self or guardian
You may not qualify if:
- fails to meet the above
- Underlying degenerative or metabolic disorder or supervening medical illness
- Severe depression or other psychiatric disorder
- Report of pregnancy by women of childbearing age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Related Publications (1)
Dietz A, Vannest J, Maloney T, Altaye M, Holland S, Szaflarski JP. The feasibility of improving discourse in people with aphasia through AAC: Clinical and functional MRI correlates. Aphasiology. 2018;32(6):693-719. doi: 10.1080/02687038.2018.1447641. Epub 2018 Mar 9.
PMID: 32999522BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aimee Dietz, PhD
University of Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 4, 2019
First Posted
September 9, 2019
Study Start
September 1, 2018
Primary Completion
August 1, 2021
Study Completion
December 1, 2021
Last Updated
September 9, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Upon study completion
Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects based on their private health information and language profiles. Further, it is possible to reconstruct faces from MRI data and the patients are easily identified through the testing and treatment videos; thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed. Data will be shared at the time of publication, or shortly thereafter.