Translating Neuroprediction Into Precision Medicine Via Brain Priming

Yale University

Status and phase: Terminated; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Drug: Oxytocin; Behavioral: Pivotal Response Treatment; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03370510

2000021581

Details and patient eligibility

About

The present study examines the impact of oxytocin (OXT) and Pivotal Response Treatment (PRT) on the development of language, social, and play skills in young children with Autism Spectrum Disorder (ASD). The purpose of this study is to examine the impact of OXT as an enhancer of response to PRT. Participants will be randomly assigned to either an intranasal OXT group or a placebo group. Neither the research team nor the participants will know or choose which group the participant is assigned to. Children in both groups will participate in a 16-week trial of PRT. The trial will test the hypothesis that children with lower levels of activity in and functional connectivity among certain PRT-response brain regions will benefit more from the administration of OXT vs. placebo as an enhancer to a 16-week trial of PRT.

Full description

This project investigates the effectiveness of a new intervention approach for Autism Spectrum Disorder (ASD) to optimize the effects of an evidence-based behavioral intervention, Pivotal Response Treatment (PRT) by attempting to enhance it with oxytocin (OXT). We will integrate fMRI, eye tracking, and behavioral outcomes to measure how OXT may create a neural background for individuals with ASD to bolster their motivation to interact socially and facilitate their biological preparedness for learning social communication skills during behavioral treatments.

Enrollment: 5 patients

Sex: All

Ages: 5 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Fit the age requirement: age 5-9
2. Have been diagnosed previously with an ASD and meet criteria for ASD when characterized by research team
3. Be in good medical health
4. Be cooperative with testing
5. Speak English in the family
6. Successfully complete an fMRI scan
7. Full-scale intelligence quotient (IQ)>70

Exclusion criteria

1. Any metal or electromagnetic implants, including:

   1. Cardiac pacemaker
   2. Defibrillator
   3. Artificial heart valve
   4. Aneurysm clip
   5. Cochlear implants
   6. Shrapnel
   7. Neurostimulators
   8. History of metal fragments in eyes or skin

2. Significant hearing loss or other severe sensory impairment

3. A fragile health status.

4. Current use of prescription psychotropic medications that may affect cognitive processes under study.

5. A history of significant head trauma or serious brain or psychiatric illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups, including a placebo group

Pivotal Response Treatment (PRT)/oxytocin (OXT) nasal spray

Experimental group

Description:

Participants will receive oxytocin nasal spray 45 minutes prior to each PRT session.

Treatment:

Drug: Oxytocin

Behavioral: Pivotal Response Treatment

Pivotal Response Treatment (PRT)/placebo nasal spray

Placebo Comparator group

Description:

Participants will receive a placebo nasal spray 45 minutes prior to each PRT session.

Treatment:

Drug: Placebo

Behavioral: Pivotal Response Treatment