Clinical trial NCT02916524: Predicting Rehabilitation Outcomes in Bilingual Aphasia Using Computational Modeling
Official title: Double-blind Randomized Trial Investigating the Use of Computational Modeling to Predict Rehabilitation Outcomes in Bilingual Aphasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aphasia
Keywords: Aphasia
Bilingualism
Language therapy
Rehabilitation of speech and language disorders
Speech-language pathology
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2016-09-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to implement a computational model that can predict and optimize training and cross-language generalization patterns for bilingual persons with aphasia (BPA). The proposed work will determine the best possible treatment program for each individual patient even before they are rehabilitated. In addition, the computational model allows specification of variables such as age of acquisition, language exposure/proficiency, impairment and their systematic influence on a range of language rehabilitation outcomes.


Eligibility criteria: Inclusion Criteria:

* Any number of years of education
* Bilingual: speaking both Spanish and English (or Chinese and English) with any degree of language proficiency prior to stroke
* Aphasia secondary to a left-hemisphere stroke (diagnosed by a neurologist on the basis of clinical CT/MRI imaging or medical reports)
* Aphasia resulting from stroke or dementia
* Naming deficits must be present with concurrent lexical/semantic impairment
* Visual and auditory acuity sufficient for all assessment and treatment procedures
* Ability to understand study and follow study procedures for the entire length of the study

Exclusion Criteria:

* Premorbid history of speech/language disorder
* Proficient in more than just Spanish and English (or Chinese and English)
* Overt, behaviorally noticeable, attentional limitations that interfere with completing the experimental tasks
* Active medical disease that may compromise participation (e.g., cancer undergoing acute treatment, unstable diabetes, renal or hepatic insufficiency, fluctuating systemic immunological disease such as systemic lupus erythematosis, etc.)
* Currently taking medications that are known to exert significant effects on cognitive processes, such as neuroleptics, steroids, anticholinesterase inhibitors, etc.
* Current drug or alcohol use or dependence that would interfere with adherence to study requirements, in the opinion of the principal investigator
* Inability or unwillingness of individual to give written informed consent
* Diagnosed with mental illness other than active depression
* Neurological condition other than that which resulted in aphasia

Primary outcomes:
measure: Word Retrieval Accuracy in both languages
timeFrame: Through study completion, an average of 10 weeks
Secondary outcomes:
measure: Psycholinguistic assessments of language processing in aphasia (PALPA) in both languages
timeFrame: Week 1 and up to 10 weeks
measure: Boston Naming Test (BNT) in both languages
timeFrame: Week 1 and up to 10 weeks
measure: Bilingual Aphasia Test (BAT) B and C in both languages
timeFrame: Week 1 and up to 10 weeks
measure: Western Aphasia Battery (WAB) in both languages
timeFrame: Week 1 and up to 10 weeks
measure: Cognitive Linguistic Quick Test (CLQT) in both languages
timeFrame: Week 1 and up to 10 weeks
measure: Verbal fluency task (COWAT) in both languages
timeFrame: Week 1 and up to 10 weeks
measure: Category fluency task in both languages
timeFrame: Week 1 and up to 10 weeks
measure: Communication Effectiveness Index (CETI) for both languages
timeFrame: Week 1 and up to 10 weeks
measure: Pyramids and Palm Trees Test (PAPT) 3 pictures version
timeFrame: Week 1 and up to 10 weeks
measure: Aphasia Bank
timeFrame: Week 1 and up to 10 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco State University
state: California
city: Boston
country: United States
facility: Boston University Sargent College
state: Massachusetts
city: Austin
country: United States
facility: Austin Speech Labs
state: Texas
Study officials:
affiliation: Boston University
name: Swathi Kiran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Penaloza C, Dekhtyar M, Scimeca M, Carpenter E, Mukadam N, Kiran S. Predicting treatment outcomes for bilinguals with aphasia using computational modeling: Study protocol for the PROCoM randomised controlled trial. BMJ Open. 2020 Nov 18;10(11):e040495. doi: 10.1136/bmjopen-2020-040495.