An Early Phase 1 interventional study of Methylphenidate and Placebo in Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 8 Years to 21 Years. Per ClinicalTrials.gov, last updated 2021-01-15.
Sponsored by Children's Hospital Medical Center, Cincinnati · Early Phase 1, Interventional, and Basic science
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.
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo pill received
Drug: Placebo
Drug: Methylphenidate
single dose methylphenidate; 0.3mg/kg, up to 20mg, rounded to the nearest 2.5mg
Placebo pill identical in appearance to methylphenidate
Change in Eye-Tracking: Microsaccades and pupil size using Tobii eye tracker
Eye tracking offers a window into a "hardwired" circuit into the brain in a patient population that may not easily tolerate more invasive diagnostic procedures.
Time frame: Pre-dose; Approximately 90 minutes post-dose of methylphenidate
Change in Short Interval IntraCortical Inhibition (SICI) using Transcranial Magnetic Stimulation (TMS)
SICI is a TMS measure of the efficiency of inhibitory interneurons in the primary motor cortex.
Time frame: Pre-dose; Approximately 90 minutes post-dose of methylphenidate
Change in Resting State Electroencephalogram (EEG)
EEG will be used to assess the electrophysiologic aspects of behavioral computerized testing, behavior, or motor function.
Time frame: Pre-dose; Approximately 90 minutes post-dose of methylphenidate
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital Medical Center, Cincinnati