NCT02874690

Eye Tracking as a Predictor of Methylphenidate Response in Autism With ADHD

Title: Eye Tracking as a Predictor of Methylphenidate Response in Autism With Co-morbid Attention Deficit Hyperactivity Disorder

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

The overall goal of this research is to use neurophysiological measures to profile strengths and deficits for Attention Deficit Hyperactivity Disorder co-morbidity in Autism Spectrum Disorder to clarify diagnosis and to predict treatment response.

Detailed description

The project "Eye Tracking as a Predictor of Methylphenidate (MPH) Response in Low Functioning Autism Spectrum Disorders (ASD) with comorbid ADHD" will investigate the role of a non-invasive neurophysiological biomarker in an underserved population to clarify diagnosis and guide treatment decisions. Specifically, we will modify an existing eye tracking paradigm that discriminates between ADHD and typical youth, for use in an ASD cohort with (ASD+) and without an ADHD comorbidity. A case-control design (Aim 1) will lead into a randomized placebo controlled trial of MPH in children with ASD with comorbid ADHD (Aim 2). We hypothesize that children with ASD+ will demonstrate specific abnormalities in microsaccades, eye blink frequency, and pupil dilatation on continuous performance testing that will predict MPH treatment response on standardized clinical outcomes for ADHD. As a secondary measure, we will also perform a brief electrophysiological measure, short interval cortical inhibition (SICI), as measured by paired pulse transcranial magnetic stimulation (TMS). We have extensively investigated this measure as a robust predictor of ADHD diagnosis and symptom severity in ADHD and typical youth. We anticipate this personalized medicine-based approach to clarify ADHD co-occurrence in ASD will result in a novel neurophysiological biomarker will enhance diagnostic reliability and better match appropriate pharmacotherapy in a highly complex neurodevelopmental disease.

Conditions

• Autism Spectrum Disorder
• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Methylphenidate	single dose methylphenidate; 0.3mg/kg, up to 20mg, rounded to the nearest 2.5mg
DRUG	Placebo	Placebo pill identical in appearance to methylphenidate

Timeline

• Start date: 2016-02-19
• Primary completion: 2017-08-03
• Completion: 2017-08-03
• First posted: 2016-08-22
• Last updated: 2021-01-15

Locations

1 site across 1 country: United States