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

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ClinicalTrials.gov Identifier: NCT02916524
Recruitment Status : Recruiting
First Posted : September 27, 2016
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Swathi Kiran, Boston University Charles River Campus

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 15, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Word Retrieval Accuracy in both languages [ Time Frame: 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 :
  1. Psycholinguistic assessments of language processing in aphasia (PALPA) in both languages [ Time Frame: Week 1 and up to 10 weeks ]
    Reading single words and understanding spoken words

  2. Boston Naming Test (BNT) in both languages [ Time Frame: Week 1 and up to 10 weeks ]
    Naming pictured items

  3. Bilingual Aphasia Test (BAT) in both languages [ Time Frame: Week 1 and up to 10 weeks ]
    Assesses each of the languages of a bilingual or multilingual individual with aphasia

  4. Western Aphasia Battery (WAB) in both languages [ Time Frame: Week 1 and up to 10 weeks ]
    Assesses the levels of impairment of aphasia

  5. Cognitive Linguistic Quick Test (CLQT) in both languages [ Time Frame: Week 1 and up to 10 weeks ]
    Assesses the contribution of cognitive deficits to language dysfunction

  6. Peanut Butter and Jelly Discourse task in both languages [ Time Frame: Week 1 and up to 10 weeks ]
    Determines narrative discourse abilities

  7. Verbal fluency task (COWAT) in both languages [ Time Frame: Week 1 and up to 10 weeks ]
    Assesses general fluency

  8. Category fluency task in both languages [ Time Frame: Week 1 and up to 10 weeks ]
    Assesses category fluency

  9. Communication Effectiveness Index (CETI) for both languages [ Time Frame: Week 1 and up to 10 weeks ]
    Determines communication effectiveness by proxy

  10. Pyramids and Palm Trees Test (PPT) 3 pictures version [ Time Frame: Week 1 and up to 10 weeks ]
    Assesses semantic processing ability



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of aphasia with naming deficits and concurrent lexical/semantic impairment
  • At least 6 months post-onset of single, left-hemisphere stroke
  • Bilingual: speaking both Spanish and English (or Chinese and English)
  • Visual and auditory acuity sufficient for experimental tasks
  • The ability to understand study procedures and comply with them for the entire length of the study

Exclusion Criteria:

  • Diagnosed with medical disease that could compromise participation (e.g., cancer undergoing acute treatment, unstable diabetes, renal or hepatic insufficiency, fluctuating systemic immunological disease such as systemic lupus erythematosis, etc.)
  • Diagnosed with mental illness other than active depression Neurological condition other than that which resulted in aphasia
  • Currently taking medications that are known to exert significant effects on cognitive processes, such as neuroleptics, steroids, anticholinesterase inhibitors, etc.
  • Overt, behaviorally noticeable, attentional limitations that interfere with completing the experimental tasks
  • Current drug or alcohol use or dependence that would interfere with adherence to study requirements, in the opinion of the principal investigator
  • Proficient in more than just Spanish and English (or Chinese and English)
  • Premorbid history of speech/language disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02916524


Contacts
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Contact: Maria Dekhtyar, BA 617-353-2706 mardek2@bu.edu

Locations
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United States, Massachusetts
Boston University Sargent College Recruiting
Boston, Massachusetts, United States, 02215
Contact: Swathi Kiran, PhD    617-358-5478    kirans@bu.edu   
Contact: Maria Dekhtyar, BA    617-353-2706    mardek2@bu.edu   
Principal Investigator: Swathi Kiran, PhD         
Sponsors and Collaborators
Boston University Charles River Campus
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Swathi Kiran, PhD Boston University

Additional Information:
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Responsible Party: Swathi Kiran, Professor, Boston University Charles River Campus
ClinicalTrials.gov Identifier: NCT02916524     History of Changes
Other Study ID Numbers: 4492E
U01DC014922-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 27, 2016    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Swathi Kiran, Boston University Charles River Campus:
Aphasia
Bilingualism
Language therapy
Rehabilitation of speech and language disorders
Speech-language pathology

Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms