NCT05548322 Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses
| NCT ID | NCT05548322 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Somatosensory Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2034-10-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 210 participants in total. It began in 2024-04-15 with a primary completion date of 2034-10-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Men and women aged between 20 and 70. * 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. Exclusion Criteria: * 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)
Contact & Investigator
Maya Elzeiere, MD
PRINCIPAL INVESTIGATOR
CNRS - Aix-Marseille University
Frequently Asked Questions
Who can join the NCT05548322 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 70 Years, studying Somatosensory Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05548322 currently recruiting?
Yes, NCT05548322 is actively recruiting participants. Contact the research team at rochelle.ackerley@univ-amu.fr for enrollment information.
Where is the NCT05548322 trial being conducted?
This trial is being conducted at Marseille, France, Marseille, France.
Who is sponsoring the NCT05548322 clinical trial?
NCT05548322 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is Maya Elzeiere, MD at CNRS - Aix-Marseille University. The trial plans to enroll 210 participants.