Cortical Metrics in Intervention Trials With Autism Spectrum Disorders

• Status: Withdrawn
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Male

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 disorders (ASDs) called the cortical metric. Absence of such an outcome measure has greatly hindered the development of treatments for core symptoms of ASD.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duke University
• Collaborator: North Carolina Translational and Clinical Sciences Institute
• Treatments: Dextromethorphan; Metronidazole

Criteria

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).

Inclusion Criteria:

• 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 Criteria:

• 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

Exclusion Criteria:

• New educational or behavioral intervention within 4 weeks of baseline

• History of non-febrile seizures, other neurological disorders, psychosis, bipolar disorder, or Tourette Syndrome.

• Any sensory impairment (i.e. deafness or blindness)

• Adverse reaction to dextromethorphan

• Inability to successfully complete and understand the reaction time subtest (cortical metrics)

• Changes in psychiatric medications within 4 weeks of baseline visit

• Taking epileptic medication (including but not limited to carbamazepine, phenobarbital, Depakote, lamictal, oxycarbazepine, topiramate)