跳至主要内容
临床试验/NCT05548322
NCT05548322招募中不适用

Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses

Institut National de la Santé Et de la Recherche Médicale, France2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2024年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
210
试验地点
2
主要终点
Microneurography recording

研究概览

简要总结

Our sense of touch is essential to explore our environment and experience life and is based on signals from receptors in the body that are sensitive to different types of stimulation. The TACTHUM projects aims to investigate the fundamental firing of mechanoreceptors in the body to various external stimuli, with an end-aim to better understand the human somatosensory system and to apply this knowledge to provide comprehensive sensory feedback in prosthetics. We have a vast system of peripheral receptors in the skin and muscles that provide us with exquisitely detailed information about our everyday interactions. When there is injury to a body part, such as in amputation, there is a significant loss of somatosensory input. Prosthetic devices have greatly developmed in the past few years, especially with the introduction of useful sensory feedback. However, there is a lot to discover both about the workings of the somatosensory system and how to recreate this to give feedback in a prosthetic device.

The main objective of the TACTHUM project is to understand how to recover and apply useful somatosensory feedback in prostheses for amputees. There are a number of other sub-objectives, to:

  1. Determine how tactile mechanoreceptors encode the texture of natural surfaces during passive and active exploration.
  2. Investigate how our sense of touch varies with emotional state.
  3. Explore what happens to our sense of touch when we explore surfaces at different temperatures.
  4. Understand the origin of our perception of humidity.
  5. Investigate differences in the encoding of tactile information with age.
  6. Determine the perceptions generated by the stimulation of single tactile afferents.
  7. Study changes in spontaneous activity and responses to tactile stimulation on the residual limb of amputees.

To accomplish these objectives, we will primarily use the technique of microneurography, in vivo recordings from peripheral nerves, to gain direct information about the firing of peripheral neurons in humans. In conjunction with this, we will use a variety of mechanical and thermal stimuli to excite somatosensory fibers and register the activity of other physiological and perceptual measures. This will allow us to gain a fuller understanding of how the incoming somatosensory signals are interpreted and processed. Overall, we aim to explore how more naturalistic tactile interactions are encoded and how these can be translated to provide realistic prosthetic feedback.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women aged between 20 and
  • Be a member of a social security scheme, or a beneficiary of such a scheme
  • Be calm enough to sit still for four hours.
  • Specific for people participating in Arm 7 on amputees: People with an upper or lower limb amputation (unilateral) of more than 2 years.

排除标准

  • Have peripheral neuropathy (diabetes, Raynaud's disease) or chronic muscle and/or sensory pain.
  • Have a neurological or psychiatric history.
  • Be subject to epilepsy.
  • Be pregnant (declared) or breastfeeding, having given birth within the last year.
  • Be afraid of injections.
  • Being under dermatological treatment.
  • Have a pacemaker.
  • Not being able to understand the information leaflet and the consent form or sign it.
  • Be subject to a legal protection measure (declarative)
  • Be a protected adult (curatorship or guardianship)

研究组 & 干预措施

Modulation of touch according to the emotional state

Experimental

干预措施: Different surfaces to be touched (Device)

Modulation of touch according to the emotional state

Experimental

干预措施: Emotional state change (Behavioral)

Effect of temperature on tactile sensitivity

Experimental

干预措施: Different surfaces to be touched (Device)

Study of tactile afferent responses to natural surfaces

Experimental

干预措施: Different surfaces to be touched (Device)

Origin of wetness perception

Experimental

干预措施: Different surfaces to be touched (Device)

Aging and tactile sensitivity

Experimental

干预措施: Different surfaces to be touched (Device)

Aging and tactile sensitivity

Experimental

干预措施: Emotional state change (Behavioral)

Aging and tactile sensitivity

Experimental

干预措施: Electrical stimulation (Device)

Tactile perceptions induced by the stimulation of single sensory fibers

Experimental

干预措施: Electrical stimulation (Device)

Study of tactile feedback after amputation

Experimental

干预措施: Different surfaces to be touched (Device)

Study of tactile feedback after amputation

Experimental

干预措施: Electrical stimulation (Device)

结局指标

主要结局

Microneurography recording

时间窗: Measured during the experiment (single event, max. 6 hours), during stimulation intervention

The discharge of a peripheral nerve fiber will be recorded during the stimulation conditions. From this recording, measures of the total number of impulses evoked, the instantaneous and average frequencies, firing variability, and frequency composition will be extracted.

次要结局

  • Electrodermal response(Measured during the experiment (single event, max. 6 hours), during stimulation intervention)
  • Perceptual ratings of roughness(Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention)
  • Electroencephalography(Measured during the experiment (single event, max. 6 hours), during stimulation intervention)
  • Electromyography(Measured during the experiment (single event, max. 6 hours), during stimulation intervention)
  • Heart rate(Measured during the experiment (single event, max. 6 hours), during stimulation intervention)
  • Perceptual ratings of pleasantness(Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention)
  • Perceptual ratings of intensity(Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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