Back to resultsPredicting Rehabilitation Outcomes in Bilingual Aphasia Using Computational Modeling (PROCoM)
Primary Purpose
Aphasia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Semantic Feature Analysis (SFA)
Sponsored by
About this trial
This is an interventional treatment trial for Aphasia focused on measuring Aphasia, Bilingualism, Language therapy, Rehabilitation of speech and language disorders, Speech-language pathology
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
Sites / Locations
- San Francisco State UniversityRecruiting
- Boston University Sargent CollegeRecruiting
- Austin Speech LabsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Model-based
Model-opposite
Sub-Study: Computational Modeling for Bilingual Dementia and Semantic Decline
Arm Description
Semantic Feature Analysis training will be provided in the language that was selected by the computational model.
Semantic Feature Analysis training will be provided in the language opposite to that which was selected by the computational model.
This is a sub-study aimed at building a computational model to simulate bilingual dementia and semantic decline.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Psycholinguistic assessments of language processing in aphasia (PALPA) in both languages
Reading single words and understanding spoken words
Boston Naming Test (BNT) in both languages
Naming pictured items
Bilingual Aphasia Test (BAT) B and C in both languages
Assesses each of the languages of a bilingual or multilingual individual with aphasia
Western Aphasia Battery (WAB) in both languages
Assesses the levels of impairment of aphasia
Cognitive Linguistic Quick Test (CLQT) in both languages
Assesses the contribution of cognitive deficits to language dysfunction
Verbal fluency task (COWAT) in both languages
Assesses general fluency
Category fluency task in both languages
Assesses category fluency
Communication Effectiveness Index (CETI) for both languages
Determines communication effectiveness by proxy
Pyramids and Palm Trees Test (PAPT) 3 pictures version
Assesses semantic processing ability
Aphasia Bank
Assesses discourse
Full Information
NCT ID
NCT02916524
First Posted
September 16, 2016
Last Updated
April 13, 2021
Sponsor
Boston University Charles River Campus
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT02916524
Brief Title
Predicting Rehabilitation Outcomes in Bilingual Aphasia Using Computational Modeling
Acronym
PROCoM
Official Title
Double-blind Randomized Trial Investigating the Use of Computational Modeling to Predict Rehabilitation Outcomes in Bilingual Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University Charles River Campus
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
Aphasia, Bilingualism, Language therapy, Rehabilitation of speech and language disorders, Speech-language pathology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Model-based
Arm Type
Experimental
Arm Description
Semantic Feature Analysis training will be provided in the language that was selected by the computational model.
Arm Title
Model-opposite
Arm Type
Active Comparator
Arm Description
Semantic Feature Analysis training will be provided in the language opposite to that which was selected by the computational model.
Arm Title
Sub-Study: Computational Modeling for Bilingual Dementia and Semantic Decline
Arm Type
No Intervention
Arm Description
This is a sub-study aimed at building a computational model to simulate bilingual dementia and semantic decline.
Intervention Type
Behavioral
Intervention Name(s)
Semantic Feature Analysis (SFA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Word Retrieval Accuracy in both languages
Description
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).
Time Frame
Through study completion, an average of 10 weeks
Secondary Outcome Measure Information:
Title
Psycholinguistic assessments of language processing in aphasia (PALPA) in both languages
Description
Reading single words and understanding spoken words
Time Frame
Week 1 and up to 10 weeks
Title
Boston Naming Test (BNT) in both languages
Description
Naming pictured items
Time Frame
Week 1 and up to 10 weeks
Title
Bilingual Aphasia Test (BAT) B and C in both languages
Description
Assesses each of the languages of a bilingual or multilingual individual with aphasia
Time Frame
Week 1 and up to 10 weeks
Title
Western Aphasia Battery (WAB) in both languages
Description
Assesses the levels of impairment of aphasia
Time Frame
Week 1 and up to 10 weeks
Title
Cognitive Linguistic Quick Test (CLQT) in both languages
Description
Assesses the contribution of cognitive deficits to language dysfunction
Time Frame
Week 1 and up to 10 weeks
Title
Verbal fluency task (COWAT) in both languages
Description
Assesses general fluency
Time Frame
Week 1 and up to 10 weeks
Title
Category fluency task in both languages
Description
Assesses category fluency
Time Frame
Week 1 and up to 10 weeks
Title
Communication Effectiveness Index (CETI) for both languages
Description
Determines communication effectiveness by proxy
Time Frame
Week 1 and up to 10 weeks
Title
Pyramids and Palm Trees Test (PAPT) 3 pictures version
Description
Assesses semantic processing ability
Time Frame
Week 1 and up to 10 weeks
Title
Aphasia Bank
Description
Assesses discourse
Time Frame
Week 1 and up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nishaat Mukadam, MA
Phone
617-353-2706
Email
mukadamn@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swathi Kiran, PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco State University
City
San Francisco
State/Province
California
ZIP/Postal Code
94132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Gray, Ph.D
Email
teresag@sfsu.edu
Facility Name
Boston University Sargent College
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Swathi Kiran, PhD
Phone
617-358-5478
Email
kirans@bu.edu
First Name & Middle Initial & Last Name & Degree
Nishaat Mukadam, MA
Phone
617-353-2706
Email
mukadamn@bu.edu
First Name & Middle Initial & Last Name & Degree
Swathi Kiran, PhD
Facility Name
Austin Speech Labs
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shilpa Shamapant, M.S., M.A. CCC/SLP
Email
shilpa@austinspeechlabs.org
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33208330
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.
Results Reference
derived
Links:
URL
http://www.bu.edu/aphasiaresearch/
Description
Aphasia Research Laboratory website
Learn more about this trial
Predicting Rehabilitation Outcomes in Bilingual Aphasia Using Computational Modeling
We'll reach out to this number within 24 hrs