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

Aphasia Clinical Trial

— NAIL  

Official title:

A Preliminary Study of the Neurobiology of AAC-Induced Language Recovery in Post-Stroke Aphasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04081207
• Other study ID #: 1R15DC017280-01
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 2021

Study information

• Verified date: September 2019
• Source: University of Cincinnati
• Contact: Aimee Dietz, PhD
• Phone: 513-558-8551
• Email: aimee.dietz[@]uc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Post-stroke Aphasia
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (1)

Aimee Dietz, Jennifer Vannest, Thomas Maloney, Mekibib Altaye, Scott Holland & Jerzy P Szaflarski (2018) The feasibility of improving discourse in people with aphasia through AAC: clinical and functional MRI correlates, Aphasiology, 32:6, 693-719, DOI: 10.1080/02687038.2018.1447641

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Aphasia Battery-Revised Aphasia Quotient	a diagnostic tool used to determine aphasia type and severity	3 years
Primary	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
Primary	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	Motor-Free Visual Perception Test-4	The Motor-Free Visual Perception Test-4 assesses visual perceptual ability without requiring motor responses.	3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Language Lateralization Indices (LI)	LI is a measure that reflects hemispheric dominance for language, while accounting for lesioned tissue.	3 years

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