The Effects of Oxytocin Treatment on Social Touch

Healthy Clinical Trial

Official title:

The Effects of Oxytocin on Social Touch: an fNIRS-based Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05265806
• Other study ID #: UESTC-neuSCAN-79
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: May 25, 2022

Study information

• Verified date: May 2023
• Source: University of Electronic Science and Technology of China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of the study is to investigate the modulatory effects of oxytocin (24IU) administration on the affective processing of touch manipulated differently in gentle caress-like stroke vs. social massage with a moderate pressure.

Description:

A randomized double-blind placebo-controlled mixed experimental design with three arms (intranasal oxytocin administration vs. oral oxytocin administration vs. placebo administration, each with 60 subjects) will be employed in the current study. 35 minutes after treatment subjects will be applied two different types of pleasant touch (social massage vs. caress-like stroking) to their calf. After each applied touch stimulation session, the subjects will be asked to rate their subjective experience of the touch including the perceived pleasantness, arousal, intensity and payment. The neural basis of touch processing will be measured via simultaneously acquired fNIRS together with skin conductance responses and the electrocardiogram recording. Blood samples will be taken before and after the treatment as well as after each run session to measure plasma oxytocin levels to explore the associations with primary outcome measure (the behavioral and neural measures of touch processing). Mixed-measure analysis of variance (ANOVA) with treatment as between-subject factor and condition as within-subject factor will be used to investigate oxytocin effects on social touch processing.

To control potential confounding effects across groups, before the experiment all participants will be asked to complete a range of Chinese versions of validated questionnaires on personality, traits, attitude towards interpersonal touch and sensitivity to reward: Autism Spectrum Quotient (ASQ), Beck Depression Inventory II (BDI), State-Trait Anxiety Inventory (STAI), the Cheek and Buss Shyness Scale (CBSS), the Adult Attachment Scale (AAS), the Childhood Trauma Questionnaire (CTQ), social touch questionnaire (STQ), Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), Sensory Over-Responsivity (SensOR) Scales and the Interpersonal Reactivity Index (C-IRI). And associations between questionnaire scores (especially the ASQ and STQ scores) with primary outcome measure will be explored to investigate modulatory effects of autistic traits. Additionally, to control for potential confounding effects of treatment on mood across the experiment, the Positive and Negative Affect Schedule (PANAS) will be administered immediately before and 30 minutes after the treatment. Participants will also complete the PANAS after each type of touch condition to further measure the modulatory effects of stroking touch and massage on mood.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 25, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Healthy subjects without any past or present psychiatric or neurological disorders and without any current psychotherapeutic medication.

Exclusion Criteria:

• Any history of brain injury, psychiatric/physical illness, alcohol/substance abuse, or other major health concern.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Intranasal oxytocin
Each subject will be assigned to administration of oxytocin intranasal spray (24 IU).
• Oral oxytocin
Each subject will be assigned to administration of oxytocin lingual spray (24 IU).
• Placebo
An identical amount of intranasal administration of placebo (identical ingredients except the peptide - i.e. glycerine and sodium chloride) will be assigned to each subject.

Locations

Country	Name	City	State
China	University of Electronic Science and Technology of China(UESTC)	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neural index: fNIRS based measures of touch processing	fNIRS-based indices of neural processing of social touch after the oxytocin and placebo administration in response to each experimental condition.	35-90 minutes after treatment administration
Primary	Behavioral index: ratings of the pleasantness, arousal, intensity and payment for the applied social touch	Ratings of perceived pleasantness, arousal, intensity and the willing to pay for the applied caress-like touch and massage after the oxytocin and placebo administration.	50-90 minutes after treatment administration
Secondary	Plasma oxytocin concentration	Basal and altered blood oxytocin concentrations for different treatment groups before and 30 minutes after the administration as well as after each touch condition.	Basal concentration before treatment and altered level during 30-90 minutes after treatment administration
Secondary	Electrophysiological index: skin conductance responses (SCR)	SCR amplitudes during touch processing to further investigate oxytocin effects on each experimental condition compared with the placebo.	35-90 minutes after treatment administration
Secondary	Electrophysiological index: heart rate variability (HRV)	HRV reflecting the variability in consecutive heartbeats calculated from electrocardiography during touch processing to further investigate oxytocin effects on each experimental condition compared with the placebo.	35-90 minutes after treatment administration
Secondary	Questionnaire scores of autistic traits	The Autism Spectrum Quotient (ASQ) scores (0~50, higher scores mean higher autistic trait) to investigate modulatory effects of autistic traits.	Before the experiment
Secondary	Gender difference in the neural and behavioral index	Gender difference in the neural and behavioral response during the touch processing for different treatment groups.	35-90 minutes after treatment administration