- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05265806
The Effects of Oxytocin Treatment on Social Touch
The Effects of Oxytocin on Social Touch: an fNIRS-based Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sichuan
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Chengdu, Sichuan, China, 611731
- University of Electronic Science and Technology of China(UESTC)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intranasal oxytocin
Participants will be randomly assigned to the administration of oxytocin intranasal spray (24 IU).
|
Each subject will be assigned to administration of oxytocin intranasal spray (24 IU).
Other Names:
|
Experimental: Oral oxytocin
Participants will be randomly assigned to the administration of oxytocin lingual spray (24 IU).
|
Each subject will be assigned to administration of oxytocin lingual spray (24 IU).
Other Names:
|
Placebo Comparator: Placebo
Participants will be randomly assigned to the administration of 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neural index: fNIRS based measures of touch processing
Time Frame: 35-90 minutes after treatment administration
|
fNIRS-based indices of neural processing of social touch after the oxytocin and placebo administration in response to each experimental condition.
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35-90 minutes after treatment administration
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Behavioral index: ratings of the pleasantness, arousal, intensity and payment for the applied social touch
Time Frame: 50-90 minutes after treatment administration
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma oxytocin concentration
Time Frame: Basal concentration before treatment and altered level during 30-90 minutes after treatment administration
|
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
|
Electrophysiological index: skin conductance responses (SCR)
Time Frame: 35-90 minutes after treatment administration
|
SCR amplitudes during touch processing to further investigate oxytocin effects on each experimental condition compared with the placebo.
|
35-90 minutes after treatment administration
|
Electrophysiological index: heart rate variability (HRV)
Time Frame: 35-90 minutes after treatment administration
|
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
|
Questionnaire scores of autistic traits
Time Frame: Before the experiment
|
The Autism Spectrum Quotient (ASQ) scores (0~50, higher scores mean higher autistic trait) to investigate modulatory effects of autistic traits.
|
Before the experiment
|
Gender difference in the neural and behavioral index
Time Frame: 35-90 minutes after treatment administration
|
Gender difference in the neural and behavioral response during the touch processing for different treatment groups.
|
35-90 minutes after treatment administration
|
Collaborators and Investigators
Investigators
- Study Chair: Qin Li, Dr., University of Electronic Science and Technology of China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UESTC-neuSCAN-79
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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