Predicting Rehabilitation Outcomes in Bilingual Aphasia Using Computational Modeling

Aphasia Clinical Trial

— PROCoM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02916524
• Other study ID #: 4492E
• Secondary ID: U01DC014922-01A1
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: July 31, 2023

Study information

• Verified date: April 2021
• Source: Boston University Charles River Campus
• Contact: Nishaat Mukadam, MA
• Phone: 617-353-2706
• Email: mukadamn[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia

Intervention

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.

Locations

Country	Name	City	State
United States	Austin Speech Labs	Austin	Texas
United States	Boston University Sargent College	Boston	Massachusetts
United States	San Francisco State University	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Boston University Charles River Campus	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Boston Naming Test (BNT) in both languages	Naming pictured items	Week 1 and up to 10 weeks
Secondary	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
Secondary	Western Aphasia Battery (WAB) in both languages	Assesses the levels of impairment of aphasia	Week 1 and up to 10 weeks
Secondary	Cognitive Linguistic Quick Test (CLQT) in both languages	Assesses the contribution of cognitive deficits to language dysfunction	Week 1 and up to 10 weeks
Secondary	Verbal fluency task (COWAT) in both languages	Assesses general fluency	Week 1 and up to 10 weeks
Secondary	Category fluency task in both languages	Assesses category fluency	Week 1 and up to 10 weeks
Secondary	Communication Effectiveness Index (CETI) for both languages	Determines communication effectiveness by proxy	Week 1 and up to 10 weeks
Secondary	Pyramids and Palm Trees Test (PAPT) 3 pictures version	Assesses semantic processing ability	Week 1 and up to 10 weeks
Secondary	Aphasia Bank	Assesses discourse	Week 1 and up to 10 weeks

External Links

•   Aphasia Research Laboratory website