Clinical trial NCT04081207: Using Augmentative & Alternative Communication to Promote Language Recovery for People With Post-Stroke Aphasia
Official title: A Preliminary Study of the Neurobiology of AAC-Induced Language Recovery in Post-Stroke Aphasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-stroke Aphasia
Aphasia
Keywords: augmentative and alternative communication
aphasia
fMRI
DTI
neuroimaging
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2019-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Western Aphasia Battery-Revised Aphasia Quotient
timeFrame: 3 years
measure: Visual Regions of Interest Activation intensity
timeFrame: 3 years
measure: Connectivity Indices
timeFrame: 3 years
Secondary outcomes:
measure: Motor-Free Visual Perception Test-4
timeFrame: 3 years
measure: Discourse Analyses
timeFrame: 3years
measure: Communication analyses
timeFrame: 3 years
measure: Stroke and Aphasia Quality of Life-39 (SAQOL-39)
timeFrame: 3 years
measure: Communication Effectiveness Index (CETI)
timeFrame: 3 years
measure: Fractional Anisotropy (FA)
timeFrame: 3 years
measure: Mean Diffusivity (MD)
timeFrame: 3 years
measure: Language Lateralization Indices (LI)
timeFrame: 3 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Aimee Dietz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.