Predicting Rehabilitation Outcomes in Bilingual Aphasia Using Computational Modeling (PROCoM)

October 15, 2026 updated by: Boston University Charles River Campus

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94132
        • San Francisco State University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Boston University Sargent College
    • Texas
      • Austin, Texas, United States, 78757
        • Austin Speech Labs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Word Retrieval Accuracy in English and Spanish
Time Frame: Through study completion, an average of 10 weeks

Accuracy of naming black and white pictures that are both trained and untrained in English and Spanish will be assessed in naming tests. These tests 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. Proportion accuracy was calculated for each set of items for every testing session. Baseline scores were compared to end of treatment scores to obtain individual effect sizes for each sets of items 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
Time Frame: Baseline, post-treatment (on average 10 weeks)

The PALPA/Evaluación del Procesamiento Lingüístico en la Afasia (EPLA) is a standardized assessment for reading simple words and spoken words in both English and Spanish out of 30 words.
Baseline, post-treatment (on average 10 weeks)
Boston Naming Test (BNT) in Both Languages
Time Frame: Baseline, post-treatment (on average 10 weeks)

The BNT is a standardized naming assessment that includes 60 pictures that can be named in either English or Spanish.
Baseline, post-treatment (on average 10 weeks)
Western Aphasia Battery (WAB-R) in Both Languages
Time Frame: Baseline, post-treatment (on average 10 weeks)

Western Aphasia Battery:The WAB-R is a standardized, gold-standard assessment for determining the presence, type, and severity of post-stroke aphasia, with excellent reliability and validity. The WAB-R measures performance across a variety of expressive and receptive language domains and takes approximately 45-60 minutes to administer. Weighted performance across four of these domains - spontaneous speech, auditory verbal comprehension, repetition, and naming/word finding - yields a composite score, the WAB-R Aphasia Quotient (AQ). The WAB-R AQ is an impairment-based metric that reliably indexes aphasia severity across different aphasia subtypes. Range is 0 t0 100.
Baseline, post-treatment (on average 10 weeks)
Pyramids and Palm Trees Test (PAPT) 3 Pictures Version
Time Frame: Baseline, post-treatment (on average 10 weeks)

The Pyramids and Palm Trees is a non-verbal (language-independent) semantic processing assessment that includes 3 pictures of which the person has to decide which two go together. There are 52 items in this test with a range of 1-52.
Baseline, post-treatment (on average 10 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2018

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

September 16, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimated)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

October 15, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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