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临床试验/NCT04614532
NCT04614532终止不适用

Recognizing Pain Intensity in Alzheimer's Disease: Autonomic Nervous System Variations and Facial Emotion

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年11月24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
28
试验地点
2
主要终点
Nociception Level Index

研究概览

简要总结

The most common form of dementia is Alzheimer's disease, with 900,000 people affected in France in 2015 and a forecast of 1.3 million in 2020. As a consequence of their advanced age, dementia patients often suffer from pain, mainly musculoskeletal or neuropathic pain. However, the exact prevalence of pain in dementia is underestimated. Indeed, several studies indicate that people suffering from dementia report less pain. This phenomenon is all the more true as the stage of dementia is advanced. In addition, people with dementia receive less pain medication than people without cognitive impairment in similarly painful conditions. Hetero-evaluation alone also seems insufficient, with the result that pain is under-treated compared to patients without cognitive impairment. Better pain screening is a major challenge and self-assessment tools should be favoured as a first line of treatment, even for patients with cognitive impairment. suffering from dementia.

The investigators propose in this work to evaluate the variation of vegetative parameters that accompany a painful stimulus. These variations can be recorded at the cardiac, vascular, pupillary or skin conductance level.

详细描述

It will therefore be a question of inducing experimental pain in patients with Alzheimer's disease, in the early stages of the disease and to check whether pain-related changes in the autonomic nervous system via the Nociception Level index (NoL® system) differ from a control group of subjects matched in age, gender and education level. To induce pain, the investigators will use the "cold pressor test" technique, which consists of leaving the arm immersed in ice water for as long as the pain is bearable. The investigators will also record before, during and after the immersion, the variations of several parameters derived from the autonomic nervous system during the painful stimulation via the NoL® system. During this experience, the participants will be filmed in their entirety to observe the facial emotions related to pain.

研究设计

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

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

patients with alzheimer's disease

Other

干预措施: digital sensor of Nociception Level Index (Other)

patients with alzheimer's disease

Other

干预措施: Cold Pressor Test (Other)

patients with alzheimer's disease

Other

干预措施: cognitive assessment (Diagnostic Test)

control subject

Other

Matching by age (± 5 years), gender, and grade level

干预措施: cognitive assessment (Diagnostic Test)

control subject

Other

Matching by age (± 5 years), gender, and grade level

干预措施: Cold Pressor Test (Other)

control subject

Other

Matching by age (± 5 years), gender, and grade level

干预措施: digital sensor of Nociception Level Index (Other)

结局指标

主要结局

Nociception Level Index

时间窗: 30 minutes

measured for at least 5 minutes before immersion of the arm to have a control measurement. The measurement will continue throughout the time of immersion of the arm and until the arm is out of the water and returns to the control measurement value. This measurement will be taken via a sensor placed on a finger of the contro-lateral hand. an index at 0 = absence of nociception, an index at 100 = maximum nociception

次要结局

  • facial recognition(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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