Status:
WITHDRAWN
Cortical Metrics in Intervention Trials With Autism Spectrum Disorders
Lead Sponsor:
Duke University
Collaborating Sponsors:
North Carolina Translational and Clinical Sciences Institute
Conditions:
Autism Spectrum Disorders
Eligibility:
MALE
8-12 years
Phase:
PHASE2
PHASE3
Brief Summary
The investigators overarching aim is to obtain preliminary data to support a larger grant to validate a novel objective, physiologically-based outcome measure for clinical trials in autism spectrum di...
Detailed Description
The cortical metric is a single numeric measurement that is calculated using a multi-parametric mathematical approach from a series of measurements of the speed, intensity, diameter, and distance betw...
Eligibility Criteria
Inclusion
- Group 1 Typically Developing Youth: We will recruit 30 typically developing boys 8-12 years old to participate in a screening visit, and two tactile perception sessions (visit 1 and 2).
- Healthy Male Boys ages 8-12
- Normal developmental milestones and school performance
- Primary caretaker is able to participate in study appointments as is indicated
Exclusion
- Significant lifetime medical history including non-febrile seizures, neurological problems, psychiatric problems or learning disabilities
- Any sensory impairment (i.e. deafness or blindness)
- 1st or 2nd degree family members with a history of ASD
- 1st or 2nd degree family members with ADHD or other developmental problems
- Adverse reaction to dextromethorphan
- Inability to successfully complete and fully understand the reaction time subtest (cortical metrics)
- Group 2 Youth with ASD: 8-12 years old: \> 30 boys will be recruited who have a known or suspected diagnosis of ASD confirmed by DSM-5 checklist and the ADOS-2 at screening.
- Inclusion Criteria:
- Male Boys ages 8-12 with ASD (confirmed by DSM-5 checklist and the ADOS-2)
- IQ's should be within the normal range (≥ 70) (by prior testing or Stanford Binet 5 at screening)
- Primary caretaker is able to participate in study appointments as is clinically indicated
- Ability of child to participate in all aspects of the protocol per investigator clinical judgment
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02212275
Start Date
August 1 2015
End Date
July 1 2016
Last Update
August 25 2016
Active Locations (2)
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1
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27517
2
Duke Center for Autism and Brain Development
Durham, North Carolina, United States, 27710