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

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.

Study Overview

• Status: Unknown
• Conditions: Aphasia; Post-stroke Aphasia
• Intervention / Treatment: Behavioral: AAC for Language Recovery (AAC-LaRc)

Detailed Description

In aphasia rehabilitation, usual care is focused on helping people recuperate as much of their pre-stroke language capacity as possible.Typically, usual care is a non-standardized therapy that is tailored to the specific needs of the person with aphasia.Once a person reaches a plateau in language recovery, AAC is implemented with a focus on circumventing, or compensating for the communication challenges associated with aphasia.

The ability of people with aphasia to (1) recover language function well-into the chronic phase of stroke recovery and (2) self-cue to promote word retrieval during anomic events offer the solution for how AAC could be employed as a dual-purpose tool to augment language recovery and compensate for deficits. This approach, however, this requires a shift in how AAC is implemented. With the goal of language recovery, treatment needs to focus on instructing people with aphasia how to use AAC as a mechanism for self-cueing, rather than as a tool to replace speaking. Based on our pilot data, we hypothesize that this novel method to AAC implementation will promote language recovery by coupling the canonical language and visual processing neural networks.

This work will also contribute to our ability to identify, a priori, who will respond to this particular AAC intervention and who will not, by combining neuroimaging with behavioral and clinical data. This has the potential to reduce the cost of healthcare for stroke recovery by implementing the most effective treatment possible. Importantly, when we identify non-responders, this will allow us to construct a profile and identify features of the AAC treatment that require adjustment to meet their unique needs.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aimee Dietz, PhD; Phone Number: 513-558-8551; Email: aimee.dietz@uc.edu
• Study Contact Backup: Name: Jennifer Vannest, PhD; Phone Number: 513-558-8518; Email: vannesjr@ucmail.uc.edu

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati
      • Contact: Aimee Dietz, PhD; Phone Number: 513-558-8551; Email: aimee.dietz@uc.edu
      • Contact: Jennifer Vannest, BS; Phone Number: Dietz 513-558-85418; Email: aimee.dietz@uc.edu
      • Principal Investigator: Aimee Dietz, PhD
      • Sub-Investigator: Jennifer Vannest, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AAC-LaRc; all participants receive the experimental treatment	Behavioral: AAC for Language Recovery (AAC-LaRc); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor-Free Visual Perception Test-4	The Motor-Free Visual Perception Test-4 assesses visual perceptual ability without requiring motor responses.	3 years
Discourse Analyses	We will calculate percentage of counted words, mazes, correct information units, t-units, during personal story retells with and without the AAC support.	3years
Communication analyses	We will calculate percentage of communication conveyed via pictures, text boxes, and speak button during personal story retells with and without the iPad AAC support.	3 years
Stroke and Aphasia Quality of Life-39 (SAQOL-39)	The SAQOL-39 is a valid and reliable measure of health related quality of life, post-stroke that uses an aphasia friendly 5 point Likert scale format.	3 years
Communication Effectiveness Index (CETI)	The CETI measures functional communication scenarios that caregivers rate the ability of the patient to complete tasks, as compared to before their stroke, via a 10 cm visual analogue scale.	3 years
Fractional Anisotropy (FA)	FA is a value of diffusion and reflects white matter density and myelination. We will examine the following tracts: (1) superior, (2) inferior fronto-occipital, (3) middle longitudinal, (4) inferior longitudinal fasciculus, (5) arcuate, and (6) uncinate	3 years
Mean Diffusivity (MD)	MD is used to map tracts and serves as a measure of health or disease in white matter. We will determine the MD for the following pathways: (1) superior, (2) inferior fronto-occipital, (3) middle longitudinal, (4) inferior longitudinal fasciculus, (5) arcuate, and (6) uncinate	3 years
Language Lateralization Indices (LI)	LI is a measure that reflects hemispheric dominance for language, while accounting for lesioned tissue.	3 years

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Aimee Dietz, PhD, University of Cincinnati

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2019
• Last Update Submitted That Met QC Criteria: September 4, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: neuroimaging; fMRI; DTI; aphasia; augmentative and alternative communication
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Stroke; Aphasia
• Other Study ID Numbers: 1R15DC017280-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Upon study completion
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No