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

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.

Study Overview

• Status: Recruiting
• Conditions: Aphasia
• Intervention / Treatment: Behavioral: Semantic Feature Analysis (SFA)

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nishaat Mukadam, MA; Phone Number: 617-353-2706; Email: mukadamn@bu.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94132
      • Recruiting
      • San Francisco State University
      • Contact: Teresa Gray, Ph.D; Email: teresag@sfsu.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Boston University Sargent College
      • Contact: Nishaat Mukadam, MA; Phone Number: 617-353-2706; Email: mukadamn@bu.edu
      • Contact: Swathi Kiran, PhD; Phone Number: 617-358-5478; Email: kirans@bu.edu
      • Principal Investigator: Swathi Kiran, PhD
  • Texas
    • Austin, Texas, United States, 78757
      • Recruiting
      • Austin Speech Labs
      • Contact: Shilpa Shamapant, M.S., M.A. CCC/SLP; Email: shilpa@austinspeechlabs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Model-based; Semantic Feature Analysis training will be provided in the language that was selected by the computational model.	Behavioral: Semantic Feature Analysis (SFA); 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.
Active Comparator: Model-opposite; Semantic Feature Analysis training will be provided in the language opposite to that which was selected by the computational model.	Behavioral: Semantic Feature Analysis (SFA); 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.
No Intervention: Sub-Study: Computational Modeling for Bilingual Dementia and Semantic Decline; This is a sub-study aimed at building a computational model to simulate bilingual dementia and semantic decline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psycholinguistic assessments of language processing in aphasia (PALPA) in both languages	Reading single words and understanding spoken words	Week 1 and up to 10 weeks
Boston Naming Test (BNT) in both languages	Naming pictured items	Week 1 and up to 10 weeks
Bilingual Aphasia Test (BAT) B and C in both languages	Assesses each of the languages of a bilingual or multilingual individual with aphasia	Week 1 and up to 10 weeks
Western Aphasia Battery (WAB) in both languages	Assesses the levels of impairment of aphasia	Week 1 and up to 10 weeks
Cognitive Linguistic Quick Test (CLQT) in both languages	Assesses the contribution of cognitive deficits to language dysfunction	Week 1 and up to 10 weeks
Verbal fluency task (COWAT) in both languages	Assesses general fluency	Week 1 and up to 10 weeks
Category fluency task in both languages	Assesses category fluency	Week 1 and up to 10 weeks
Communication Effectiveness Index (CETI) for both languages	Determines communication effectiveness by proxy	Week 1 and up to 10 weeks
Pyramids and Palm Trees Test (PAPT) 3 pictures version	Assesses semantic processing ability	Week 1 and up to 10 weeks
Aphasia Bank	Assesses discourse	Week 1 and up to 10 weeks

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Swathi Kiran, PhD, Boston University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Aphasia Research Laboratory website

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2018
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: September 16, 2016
• First Submitted That Met QC Criteria: September 26, 2016
• First Posted (Estimate): September 27, 2016

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Aphasia; Rehabilitation of speech and language disorders; Speech-language pathology; Language therapy; Bilingualism
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: 4492E; U01DC014922-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No