Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses
NCT ID: NCT05548322
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
210 participants
INTERVENTIONAL
2024-04-15
2034-11-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Study of tactile afferent responses to natural surfaces
Different surfaces to be touched
The participant will touch various different surfaces and textures, including ones of different temperature and including solids and liquids.
Modulation of touch according to the emotional state
Different surfaces to be touched
The participant will touch various different surfaces and textures, including ones of different temperature and including solids and liquids.
Emotional state change
The emotional state of the participant will be modulated by listening to music.
Effect of temperature on tactile sensitivity
Different surfaces to be touched
The participant will touch various different surfaces and textures, including ones of different temperature and including solids and liquids.
Origin of wetness perception
Different surfaces to be touched
The participant will touch various different surfaces and textures, including ones of different temperature and including solids and liquids.
Aging and tactile sensitivity
Different surfaces to be touched
The participant will touch various different surfaces and textures, including ones of different temperature and including solids and liquids.
Emotional state change
The emotional state of the participant will be modulated by listening to music.
Electrical stimulation
The participant will receive electrical stimulation of single nerve fibers (a few microamps) to artificially excite an individual afferent.
Tactile perceptions induced by the stimulation of single sensory fibers
Electrical stimulation
The participant will receive electrical stimulation of single nerve fibers (a few microamps) to artificially excite an individual afferent.
Study of tactile feedback after amputation
Different surfaces to be touched
The participant will touch various different surfaces and textures, including ones of different temperature and including solids and liquids.
Electrical stimulation
The participant will receive electrical stimulation of single nerve fibers (a few microamps) to artificially excite an individual afferent.
Interventions
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Different surfaces to be touched
The participant will touch various different surfaces and textures, including ones of different temperature and including solids and liquids.
Emotional state change
The emotional state of the participant will be modulated by listening to music.
Electrical stimulation
The participant will receive electrical stimulation of single nerve fibers (a few microamps) to artificially excite an individual afferent.
Eligibility Criteria
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Inclusion Criteria
* 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 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)
20 Years
70 Years
ALL
Yes
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Responsible Party
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Principal Investigators
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Maya Elzeiere, MD
Role: PRINCIPAL_INVESTIGATOR
CNRS - Aix-Marseille University
Rochelle Ackerley, PhD
Role: STUDY_DIRECTOR
CNRS - Aix-Marseille University
Locations
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CNRS - Aix-Marseille University UMR7291
Marseille, , France
Hôpital HIA Lavéran
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-A01604-37
Identifier Type: REGISTRY
Identifier Source: secondary_id
C21-19
Identifier Type: -
Identifier Source: org_study_id
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