Predicting Rehabilitation Outcomes in Bilingual Aphasia Using Computational Modeling
PROCoM
Double-blind Randomized Trial Investigating the Use of Computational Modeling to Predict Rehabilitation Outcomes in Bilingual Aphasia
2 other identifiers
interventional
48
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2016
CompletedFirst Posted
Study publicly available on registry
September 27, 2016
CompletedStudy Start
First participant enrolled
April 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedApril 19, 2021
April 1, 2021
3.3 years
September 16, 2016
April 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Word Retrieval Accuracy in both languages
Accuracy of naming of pictured treated and untreated items in both languages will be assessed in probes conducted separate from treatment. Probes were conducted repeatedly throughout the study, from baseline (prior to treatment) to the end of treatment. All naming responses were scored using as correct or incorrect. A percentage accuracy was calculated for each set of items for every probe session. Baseline probe scores were compared to end of treatment probe scores to obtain individual effect sizes for each sets of items for each participant (i.e., several effect sizes were calculated for each participant).
Through study completion, an average of 10 weeks
Secondary Outcomes (10)
Psycholinguistic assessments of language processing in aphasia (PALPA) in both languages
Week 1 and up to 10 weeks
Boston Naming Test (BNT) in both languages
Week 1 and up to 10 weeks
Bilingual Aphasia Test (BAT) B and C in both languages
Week 1 and up to 10 weeks
Western Aphasia Battery (WAB) in both languages
Week 1 and up to 10 weeks
Cognitive Linguistic Quick Test (CLQT) in both languages
Week 1 and up to 10 weeks
- +5 more secondary outcomes
Study Arms (3)
Model-based
EXPERIMENTALSemantic Feature Analysis training will be provided in the language that was selected by the computational model.
Model-opposite
ACTIVE COMPARATORSemantic Feature Analysis training will be provided in the language opposite to that which was selected by the computational model.
Sub-Study: Computational Modeling for Bilingual Dementia and Semantic Decline
NO INTERVENTIONThis is a sub-study aimed at building a computational model to simulate bilingual dementia and semantic decline.
Interventions
SFA training entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, action associated with item). Treatment is applied to a set of items in the context of single-subject, multiple baseline designs so that replication of treatment effects could be evaluated within and across participants. Treatment will be administered two times per week until prescribed accuracy levels were met during treatment probes or a maximum number of treatment sessions was completed.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
San Francisco State University
San Francisco, California, 94132, United States
Boston University Sargent College
Boston, Massachusetts, 02215, United States
Austin Speech Labs
Austin, Texas, 78757, United States
Related Publications (2)
Russell-Meill M, Carpenter E, Marte MJ, Scimeca M, Penaloza C, Kiran S. Measurement of cross-language and cross-domain generalization following semantic feature-based anomia treatment in bilingual aphasia. Neuropsychol Rehabil. 2025 Jun 26:1-27. doi: 10.1080/09602011.2025.2522196. Online ahead of print.
PMID: 40571559DERIVEDPenaloza 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.
PMID: 33208330DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Swathi Kiran, PhD
Boston University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 16, 2016
First Posted
September 27, 2016
Study Start
April 20, 2018
Primary Completion
July 31, 2021
Study Completion
July 31, 2023
Last Updated
April 19, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share