Understanding Oxytocin's Neural and Behavioral Effects in Adolescents Diagnosed With Autism

Study Overview
=================
Brief Summary
-----------------
The investigators explored the neural and behavioral effect of oxytocin on youth with Autism spectrum disorder using magnetoencephalography (MEG). The investigators hypothesize that oxytocin will modulate neural activity to resemble patterns observed in the age-matched control group. Thirty-two adolescents with autism and 26 typically developing adolescents participated in this randomized, double-blind MEG study. Individuals with autism arrived at the lab twice and received an acute dose of intranasal oxytocin or placebo in each session. During the scans, participants were asked to complete several tasks related to social perception - such as identification of social and non-social stimuli.

Detailed Description
-----------------
In the current study, the investigators aimed to explore oxytocin's influences on neural components that relate to social processing. Namely, we focused on M100, M170, and M250, which tend to show atypical patterns in individuals with autism. The investigators also examined the effects of oxytocin on time dynamics - the change in specific oscillation over time and its effects on neural connectivity patterns.

Official Title
-----------------
Understanding Oxytocin's Neural and Behavioral Effects in Adolescents Diagnosed With Autism

Conditions
-----------------
Oxytocin, Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Drug: Oxytocin: Including placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males, aged 12-18 years Native Hebrew speakers Normal or corrected-to-normal vision Participants in the ASD group had to meet the criteria for ASD in the diagnostic and statistical manual of mental disorders (DSM-5) Exclusion Criteria: Chronic medical problems Cardiovascular risk factors CNS disease Other mental illnesses Use of prohibited medications Mental retardation Impaired vision Impaired hearing History of significant head injury or neurological illness Current substance dependence diagnosis Metallic implants, braces or devices in the body

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Youth with autism participated in a randomized, double-blind placebo-controlled trial. Participants visited the lab for two sessions. In one of the sessions, they received oxytocin, and in the other, they received the placebo. Intranasal doses of 40 international units of oxytocin (IU)/mL were prepared by the Maayan-Haim pharmacy, Israel. We used age-dependent dosing such that participants aged 13-18 years received a dose of 24 IU (3 puffs to each nostril), and younger participants (aged 12 years) received 16 IU. Typically-developing youth underwent the same experimental procedure but did not receive oxytocin or placebo due to ethical constraints in Israel.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adolescents diagnosed with Autism spectrum disorder<br>Participants in the ASD group received oxytocin and placebo in a randomized, double-blind placebo-controlled manner. | Drug: Oxytocin: Including placebo<br>* Individual received age-dependent dosing of oxytocin and placebo. Participants aged 13-18 years received a dose of 24 IU (3 puffs to each nostril), and younger participants (aged 12 years) received 16 IU.<br>|
| No Intervention: Typically developing adolescents<br>Control participants were recruited using online ads. This group did not receive oxytocin or placebo due to ethical constraints in Israel. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in social-related neural components (time-locked neural activity) with and without oxytocin | The amplitude (tesla) of three social related neural components will be measured using MEG device | During each session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in oscillatory activity - power magnitude of Delta, Theta, Alpha, Beta and Gamma neural bands with and without oxytocin | The overall power of neural oscillatory activity will be measured using MEG device | During each session | 
| The change in behavioral measurments - reaction times and accurecy rates, with and without oxytocin | Reaction times will be measured in milliseconds and accurecy rates will be defined as the percentage of correct responses | During each session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism, MEG, Social perception