The Effects of Orally Administered Oxytocin on Behavioral and Neural Responses to Self Versus Other Touch Distinction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Behavioral index: pleasantness ratings for the different types of applied touch
研究概览
简要总结
The main aim of the study is to investigate the modulatory effects of oxytocin (24IU) administered orally using medicated lollipops on the behavioral and neural responses to touching yourself compared with being touched by others.
详细描述
In a double-blind placebo-controlled within-subject experimental design, 40 adult male subjects will be randomly allocated to either receive oral oxytocin (24IU, medicated lollipop) or placebo (lollipop without oxytocin). Starting 45 minutes after treatment a resting state functional magnetic resonance imaging (fMRI) will be recorded (8min) and next subjects will be applied two different types of stroking touch (self- vs. other-produced touch) to their left arm repeated in 16 blocks. After each block of applied touch stimulation, subjects will be required to rate their perceived pleasantness of touch from -4 (extremely unpleasant) to 4 (extremely pleasant). The neural basis of touch processing will be measured via simultaneously acquired fMRI.
To control potential confounding effects among subjects, 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 interoceptive ability: Autism Spectrum Quotient (ASQ), Beck Depression Inventory II (BDI), State-Trait Anxiety Inventory (STAI), Social Touch Questionnaire (STQ),Sensory Over-Responsivity (SensOR) Scales, Interpersonal Reactivity Index (C-IRI), Self-Concept Clarity Scale (SCCS), Interoceptive Confusion Questionnaire(ICQ) and Multidimensional Assessment of Interoceptive Awareness(MAIA) scale. 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 the touch stimulations to further measure the modulatory effects of touch on mood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects without any past or present psychiatric or neurological disorders and without any current psychotherapeutic medication.
排除标准
- •Any history of brain injury, psychiatric/physical illness, alcohol/substance abuse, or other major health concern.
研究组 & 干预措施
Oral oxytocin then placebo
Subjects will first receive oral lollipop with oxytocin (24IU). After a washout period of 2 weeks, they will then receive oral lollipop with placebo (identical ingredients, except the active agent).
干预措施: oral lollipop with oxytocin (24IU) (Drug)
Oral oxytocin then placebo
Subjects will first receive oral lollipop with oxytocin (24IU). After a washout period of 2 weeks, they will then receive oral lollipop with placebo (identical ingredients, except the active agent).
干预措施: oral lollipop with placebo (Drug)
Oral placebo then oxytocin
Subjects will first receive oral lollipop with placebo (identical ingredients, except the active agent). After a washout period of 2 weeks, they will then receive oral lollipop with oxytocin (24 IU).
干预措施: oral lollipop with oxytocin (24IU) (Drug)
Oral placebo then oxytocin
Subjects will first receive oral lollipop with placebo (identical ingredients, except the active agent). After a washout period of 2 weeks, they will then receive oral lollipop with oxytocin (24 IU).
干预措施: oral lollipop with placebo (Drug)
结局指标
主要结局
Behavioral index: pleasantness ratings for the different types of applied touch
时间窗: 53-75 minutes after treatment administration
Ratings of perceived pleasantness for the two types of repeatedly applied touch (after each block of touch, subjects will need to complete the question 'how pleasant do they feel for the applied touch?' using a 9-point Likert scale ranging from -4 to +4, with higher positive scores indicating greater perceived pleasantness and higher negative scores indicating greater unpleasantness) will be compared between the oxytocin and placebo administration groups.
Neural index: fMRI based measures of altered neural activity in response to different types of applied touch
时间窗: 53-75 minutes after treatment administration
fMRI-based indices of neural activation (blood oxygen level dependent changes) in response to repeated self vs other touch will be compared between subjects in the oxytocin and placebo administration groups.
次要结局
- Behavioral associations with questionnaire scores for attitudes towards touch using the Social Touch Questionnaire Questionnaire (STQ)(Before the experiment)
- Behavioral associations with questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)(Before the experiment)
- Resting state fMRI connectivity(45-53 minutes after treatment)
- Resting state fMRI connectivity and questionnaire scores of Autism Spectrum Quotient (ASQ) for measuring autistic traits(Pre-treatment for ASQ and 45-53 minutes after treatment for resting state)
- Questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)(Before the experiment)
- Behavioral associations with autistic traits using the Autism Spectrum Quotient (ASQ)(Before the experiment)
- Resting state fMRI connectivity association with behavioral responses to touch(45-53 minutes after treatment for resting state and 53-75 minutes after treatment for behavioral measures)
- Questionnaire scores for attitudes towards touch using the Social Touch Questionnaire(Before the experiment)
- Questionnaire scores for autistic traits using the Autism Spectrum Quotient (ASQ)(Before the experiment)
- Resting state fMRI connectivity and questionnaire scores of Self-Concept Clarity Scale (SCCS) for measuring self-concept(Pre-treatment for SCCS and 45-53 minutes after treatment for resting state)
- Neural associations with autistic traits using the Autism Spectrum Quotient (ASQ)(Before the experiment)
- Neural associations with questionnaire scores for self-concept using the Self-Concept Clarity Scale (SCCS)(Before the experiment)
- Neural associations with questionnaire scores for attitudes towards touch using the Social Touch Questionnaire (STQ)(Before the experiment)
- Resting state fMRI connectivity and questionnaire scores of Social Touch Questionnaire (STQ) for measuring responses to touch(Pre-treatment for STQ and 45-53 minutes after treatment for resting state)
研究者
Keith Kendrick
Professor
University of Electronic Science and Technology of China