PROCoM: Predicting Rehabilitation Outcomes in Bilingual Aphasia Using Computational Modeling

Sponsor

Boston University Charles River Campus (Other)

Overall Status

Recruiting

CT.gov ID

NCT02916524

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)

Enrollment

Locations

Arms

63.3

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aphasia	Behavioral: Semantic Feature Analysis (SFA)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Double-blind Randomized Trial Investigating the Use of Computational Modeling to Predict Rehabilitation Outcomes in Bilingual Aphasia

Actual Study Start Date :

Apr 20, 2018

Anticipated Primary Completion Date :

Jul 31, 2021

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

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.

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)

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco State University	San Francisco	California	United States	94132
2	Boston University Sargent College	Boston	Massachusetts	United States	02215
3	Austin Speech Labs	Austin	Texas	United States	78757