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临床试验/NCT02277756
NCT02277756终止不适用

Pain Neuromodulation in Adults With Autism Spectrum Disorder

University Hospital, Brest1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2015年5月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
39
试验地点
1
主要终点
Pain as assessed by Computerized Visual analog scale

研究概览

简要总结

Pain insensibility is often described in people with autism. The aim of this study is to test the pain perception in adults with autistic spectrum disorder without intellectual disability. An experimental model of pain is used to measure endogenous modulation systems. Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms. Salivary cortisol and automatic nervous system (heart rate and blood pressure with an electrocardiogram (Brest :system dantec keypoint natus G3 ; Paris: nexfin HD®) are also tested and behavioral response to thermal stimulation assessed by an inspired behavior scale.

详细描述

Adults with autism without intellectual disability (IQ > 85) are matched with members of siblings and control group (sex and chronological age).

Pain reactivity (Visual analog scale,endogenous modulation systems, salivary cortisol, automatic nervous system and behavioral responses to thermal stimulation assessed by an inspired behavior scale.) in adult with autism is tested using an experimental model of pain. Excitatory and inhibitory modulation systems were elicited using a temporal summation test administered before and after activation of the Diffuse Noxious Inhibitory Control (DNIC) by means of a cold-pressor test.

Demographic and clinical data are also collected (sensory profile, sleep disorders and depression inventory).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • chronic pain
  • pregnancy, breast feeding
  • consent form no signed
  • Exclusion criteria sibling and witness groups:
  • diagnosis of autism or developmental disorder

研究组 & 干预措施

high functioning Autism

Experimental

Thermal stimulation with test thermode Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with high functioning Autism

干预措施: thermode (Device)

witness

Placebo Comparator

Thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms with a witness

干预措施: thermode (Device)

结局指标

主要结局

Pain as assessed by Computerized Visual analog scale

时间窗: one day

次要结局

  • salivary cortisol(one day)
  • Behavioral response to thermal stimulation assessed by an inspired EDM-DI behavior scale(one day)
  • heart rate variability(one day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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