NCT02916524

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
1.6 years until next milestone

Study Start

First participant enrolled

April 20, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

3.3 years

First QC Date

September 16, 2016

Last Update Submit

April 13, 2021

Conditions

Keywords

AphasiaBilingualismLanguage therapyRehabilitation of speech and language disordersSpeech-language pathology

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

EXPERIMENTAL

Semantic Feature Analysis training will be provided in the language that was selected by the computational model.

Behavioral: Semantic Feature Analysis (SFA)

Model-opposite

ACTIVE COMPARATOR

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)

Sub-Study: Computational Modeling for Bilingual Dementia and Semantic Decline

NO INTERVENTION

This 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.

Model-basedModel-opposite

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

Boston University Sargent College

Boston, Massachusetts, 02215, United States

RECRUITING

Austin Speech Labs

Austin, Texas, 78757, United States

RECRUITING

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.

  • 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.

Related Links

MeSH Terms

Conditions

AphasiaLanguage Disorders

Condition Hierarchy (Ancestors)

Speech DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Swathi Kiran, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nishaat Mukadam, MA

CONTACT

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

Locations