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Using Augmentative & Alternative Communication to Promote Language Recovery for People With Post-Stroke Aphasia (NAIL)

Primary Purpose

Post-stroke Aphasia, Aphasia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AAC for Language Recovery (AAC-LaRc)
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-stroke Aphasia focused on measuring augmentative and alternative communication, aphasia, fMRI, DTI, neuroimaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of CincinnatiRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AAC-LaRc

Arm Description

all participants receive the experimental treatment

Outcomes

Primary Outcome Measures

Western Aphasia Battery-Revised Aphasia Quotient
a diagnostic tool used to determine aphasia type and severity
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.
Connectivity Indices
Connectivity indices reflect the temporal correlation between canonical language and visual regions of interest during language and resting state fMRI tasks.

Secondary Outcome Measures

Motor-Free Visual Perception Test-4
The Motor-Free Visual Perception Test-4 assesses visual perceptual ability without requiring motor responses.
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.
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.
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.
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.
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
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
Language Lateralization Indices (LI)
LI is a measure that reflects hemispheric dominance for language, while accounting for lesioned tissue.

Full Information

First Posted
September 4, 2019
Last Updated
September 4, 2019
Sponsor
University of Cincinnati
Collaborators
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT04081207
Brief Title
Using Augmentative & Alternative Communication to Promote Language Recovery for People With Post-Stroke Aphasia
Acronym
NAIL
Official Title
A Preliminary Study of the Neurobiology of AAC-Induced Language Recovery in Post-Stroke Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
Children's Hospital Medical Center, Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Aphasia, Aphasia
Keywords
augmentative and alternative communication, aphasia, fMRI, DTI, neuroimaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participant cohorts: We will use a 2 (groups) X 4 (measurement time points) switching replications design[18] to examine the effects of AAC on aphasia severity and spoken language (AIM 1), elucidate the neurobiological mechanism of AAC-induced language recovery (AIM 2), and identify AAC treatment responder subgroups (Exploratory Aim). This design will allow Group 2 to serve as the control group; however, they will still receive AAC treatment; thus, allowing us to increase the total N who receives AAC treatment to 20 people.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AAC-LaRc
Arm Type
Experimental
Arm Description
all participants receive the experimental treatment
Intervention Type
Behavioral
Intervention Name(s)
AAC for Language Recovery (AAC-LaRc)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Western Aphasia Battery-Revised Aphasia Quotient
Description
a diagnostic tool used to determine aphasia type and severity
Time Frame
3 years
Title
Visual Regions of Interest Activation intensity
Description
A functional magnetic resonance imaging (fMRI) measure to indicate change in brain involvement during resting state and language tasks.
Time Frame
3 years
Title
Connectivity Indices
Description
Connectivity indices reflect the temporal correlation between canonical language and visual regions of interest during language and resting state fMRI tasks.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Motor-Free Visual Perception Test-4
Description
The Motor-Free Visual Perception Test-4 assesses visual perceptual ability without requiring motor responses.
Time Frame
3 years
Title
Discourse Analyses
Description
We will calculate percentage of counted words, mazes, correct information units, t-units, during personal story retells with and without the AAC support.
Time Frame
3years
Title
Communication analyses
Description
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.
Time Frame
3 years
Title
Stroke and Aphasia Quality of Life-39 (SAQOL-39)
Description
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.
Time Frame
3 years
Title
Communication Effectiveness Index (CETI)
Description
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.
Time Frame
3 years
Title
Fractional Anisotropy (FA)
Description
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
Time Frame
3 years
Title
Mean Diffusivity (MD)
Description
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
Time Frame
3 years
Title
Language Lateralization Indices (LI)
Description
LI is a measure that reflects hemispheric dominance for language, while accounting for lesioned tissue.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aimee Dietz, PhD
Phone
513-558-8551
Email
aimee.dietz@uc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Vannest, PhD
Phone
513-558-8518
Email
vannesjr@ucmail.uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aimee Dietz, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimee Dietz, PhD
Phone
513-558-8551
Email
aimee.dietz@uc.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Vannest, BS
Phone
513-558-85418
Ext
Dietz
Email
aimee.dietz@uc.edu
First Name & Middle Initial & Last Name & Degree
Aimee Dietz, PhD
First Name & Middle Initial & Last Name & Degree
Jennifer Vannest, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
32999522
Citation
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.
Results Reference
background

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Using Augmentative & Alternative Communication to Promote Language Recovery for People With Post-Stroke Aphasia

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