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Brain Mechanisms for Language Processing in Adolescents With Autism Spectrum Disorder (BSL)

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ClinicalTrials.gov Identifier: NCT02700074
Recruitment Status : Recruiting
First Posted : March 7, 2016
Last Update Posted : January 19, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Massachusetts General Hospital
Northeastern University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Helen B. Tager-Flusberg, Boston University

Brief Summary:
The main goal of our study is to find out why some people with Autism Spectrum Disorder (ASD) do not develop verbal abilities or remain minimally-verbal throughout adolescence and adulthood. Current research focuses on investigating brain differences related to processing sounds and initiating speech in adolescents and young adults with ASD varying in language skills, compared to adolescents who do not have ASD, in order to clarify whether atypical processes of auditory perception, perceptual organization and/or neural oscillation patterns may explain why some individuals with ASD fail to acquire functional speech.

Condition or disease Intervention/treatment
Autism Spectrum Disorders Other: No Intervention

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: ACE (Autism Center of Excellence): Brain Mechanisms for Language Processing in Adolescents With Autism Spectrum Disorder
Study Start Date : February 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Minimally Verbal
Minimally verbal adolescents with Autism Spectrum Disorder
Other: No Intervention
Intervention is not a part of this study.

Verbal Impaired
Language impaired adolescents with ASD
Other: No Intervention
Intervention is not a part of this study.

Verbal Normal
Language normal adolescents with ASD
Other: No Intervention
Intervention is not a part of this study.

Typically Developing
Typically developing adolescent controls
Other: No Intervention
Intervention is not a part of this study.




Primary Outcome Measures :
  1. Autism Spectrum Diagnosis [ Time Frame: 5 years ]
    Interview

  2. Adaptive Behaviors [ Time Frame: 5 years ]
    Interview

  3. Cognitive Abilities [ Time Frame: 5 years ]
    Interview

  4. Language Abilities [ Time Frame: 5 years ]
    Interview and Questionnaire

  5. Social Behavior [ Time Frame: 5 years ]
    Interview

  6. Repetitive Behavior [ Time Frame: 5 years ]
    Questionnaire

  7. Sensory Behavior [ Time Frame: 5 years ]
    Questionnaire

  8. Atypical Behavior [ Time Frame: 5 years ]
    Questionnaire

  9. Psychopathology [ Time Frame: 5 years ]
    Questionnaire

  10. Emotion Regulation [ Time Frame: 5 years ]
    Questionnaire

  11. Handedness [ Time Frame: 5 years ]
    Questionnaire

  12. Brain measures of structural and functional connectivity in key nodes of the speech production network [ Time Frame: 5 years ]
    In particular between the supplementary motor area (SMA) and ventral premotor cortex (vPMC), a set of nodes in the speech network that is critical for the initiation of speech motor programs. High resolution MRI brain scans collected from adolescents with ASD who vary in their language ability from minimally verbal to normal (and a typical control group). Measures of structural anatomical connectivity based on Diffusion Tensor Imaging (DTI) data and functional connectivity based on resting state functional connectivity MRI.

  13. Electrophysiological measures and neural oscillatory patterns of the perception, organization and analysis of auditory scenes. [ Time Frame: 5 years ]
    Physiological parameter

  14. Indices of social attention deployment measured by unobtrusively recording participants' eye-movements during the passive viewing of brief realistic video-clips. [ Time Frame: 5 years ]
    Physiological parameter

  15. Indices of electrodermal activity (EDA) measured wirelessly with the Q sensor (a small wearable device designed to work in real-world environments in an untethered, unobtrusive way). [ Time Frame: 5 years ]
    Physiological parameter



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Ages Eligible for Study:   14 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

Inclusion Criteria:

  • Between the ages of 14 and 21
  • Minimally verbal (which is defined as having fewer than 10 words/phrases used communicatively during the Autism Diagnostic Observation Schedule (ADOS) assessment
  • Demonstrated minimal progress in speech acquisition despite having participated in speech therapy for at least 18 months
  • Diagnosis of Autism Spectrum Disorder (ASD)
  • Verbal but language impaired (defined as more than 1.25 standard deviation below the mean on the clinical evaluation of language fundamentals - Fourth edition (CELF-4))
  • Has normal language scores (on the CELF-4)
  • Is typically developing with no history of psychiatric or neurological disorders

Exclusion Criteria:

  • Has contraindications to having a magnetic resonance imaging (MRI) scan (e.g. electronic/ferromagnetic implant, clips, stents, existing or planned major dental work)
  • Has a history of significant neurological diseases
  • Has a history of sensory impairment (e.g., hearing impairment)
  • Has a history of disorders other than ASD
  • Is currently taking antipsychotic medications.

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): NCT02700074


Contacts
Contact: Helen Tager-Flusberg, PhD 1-617-358-5910 htagerf@bu.edu
Contact: Brittany Dorer, M.Ed 6173585912 bdorer@bu.edu

Locations
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02215
Contact: Helen Tager-Flusberg, PhD    617-358-5910    htagerf@bu.edu   
Contact: Brittany Dorer, M.Ed    6173585912    bdorer@bu.edu   
Principal Investigator: Helen Tager-Flusberg, PhD         
Sub-Investigator: Daniela Plesa-Skwerer, PhD         
Sponsors and Collaborators
Boston University Charles River Campus
National Institutes of Health (NIH)
Massachusetts General Hospital
Northeastern University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Helen Tager-Flusberg, PhD Boston University

Additional Information:
Publications:
Responsible Party: Helen B. Tager-Flusberg, Professor, Boston University
ClinicalTrials.gov Identifier: NCT02700074     History of Changes
Other Study ID Numbers: 3077E
P50DC013027 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders