Oxytocin, Emotions and Mirror Neurons

Social Cognition Clinical Trial

Official title:

The Influence of Oxytocin on the Mirror Neuron System: Developing Brain Imaging Paradigms for Future Therapeutic Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228031
• Other study ID #: HP-00059904
• Status: Completed
• Phase: Early Phase 1
• Start date: October 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this project is to investigate the possible effect of intranasally administered Oxytocin (OT) on specific mirror neuron areas in human brain. The mirror neuron system (MNS) is thought to be involved in action perception and understanding, and may also underlie more complex cognitive processes such as imitation. We will use electroencephalographic (EEG) investigations to examine brain activity while participants complete two different tasks, consisting of the observation and imitation of emotional facial expressions (video presented) and the observation and execution of simple grasping actions (live presented), respectively. In addition, before the beginning of the EEG recording session, subjects will be randomly assigned to two different groups (Oxytocin or Placebo group) and will receive a dose of either intranasal Oxytocin or Placebo solution. Oxytocin is a polypeptide hormone that plays a critical role in social behavior. We will identify mu and beta rhythm from the ongoing EEG and examine suppression as a function of emotion and goal directed action perception and imitation/execution.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Right-hand dominant

• Sufficient spoken English so as to be able to complete testing validly and give informed consent

Exclusion Criteria:

• Currently taking any psychotropic or cognition enhancing medication

• History of schizophrenia or any other psychotic disorder, including Bipolar Disorder

• Family history of psychosis

• Neurological disease or clinically significant head injury

• Physical disability that substantially impairs motor function

• Current diagnosis of polydypsic-induced hyponatremia

• Substance dependence or abuse in the past 6 months

Related Conditions & MeSH terms

• Expressed Emotion
• Social Cognition

Intervention

Drug:
• Oxytocin
The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session

Other:
• Placebo
The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.

Locations

Country	Name	City	State
United States	Child Development Lab, University of Maryland	College Park	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	University of Maryland, College Park

Country where clinical trial is conducted

United States, 

References & Publications (1)

Carr L, Iacoboni M, Dubeau MC, Mazziotta JC, Lenzi GL. Neural mechanisms of empathy in humans: a relay from neural systems for imitation to limbic areas. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5497-502. Epub 2003 Apr 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG mu rhythm suppression	The EEG mu rhythm suppression is an index of the human mirror neuron system (alpha and lower beta band activity (8-13 and ~20Hz) recorded over the sensorimotor cortex. EEG will be recorded during the performance of an emotion imitation task (Carr et al., 2003) in which participants will be asked to imitate and internally generate facial emotions seen on a computer screen, or to simply observe, as well as performing a simple grasping action task. Changes in the mu suppression while the performance of these tasks, before and after oxytocin/placebo administration, will be the primary outcome measure.	Before oxytocin/placebo administration and 45 minutes after