Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses (TACTHUM)
Primary Purpose
Somatosensory Disorders, Amputation, Tactile Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Different surfaces to be touched
Emotional state change
Electrical stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Somatosensory Disorders focused on measuring Touch, Temperature, Somarosensation, Prosthetics, Microneurography, Tactile, Mechanoreceptor
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)
Sites / Locations
- CNRS - Aix-Marseille University UMR7291
- Hôpital HIA Lavéran
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Study of tactile afferent responses to natural surfaces
Modulation of touch according to the emotional state
Effect of temperature on tactile sensitivity
Origin of wetness perception
Aging and tactile sensitivity
Tactile perceptions induced by the stimulation of single sensory fibers
Study of tactile feedback after amputation
Arm Description
Outcomes
Primary Outcome Measures
Microneurography recording
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.
Secondary Outcome Measures
Electrodermal response
Electrodermal response will be recorded from electrodes attached to the glabrous skin, to register further effects of the stimulation on the body.
Heart rate
Heart rate will be recorded via three electrodes on the skin, to register further effects of the stimulation on the body.
Electromyography
Electromyography (EMG) will be recorded from surface skin electrodes over the muscle, to register further effects of the stimulation on the body. From this recording, measures of the total activity (area under the curve) during a stimulation period and the frequency composition will be extracted.
Electroencephalography
Electroencephalography (EEG) will be recorded from surface scalp skin using a 64 electrodes setup, to register further effects of the stimulation on brain responses. From this recording, measures of the event-related potentials to stimulation will be analyzed and the frequency composition (theta, alpha, beta, gamma) of the response will be extracted.
Perceptual ratings of pleasantness
The perceptual rating of the perceived pleasantness of different applied stimuli will be gained to determine the overt sensations induced by the stimulation. The scale is a visual analog scale with the anchors 'pleasant' and 'unpleasant' that outputs a scale of 0 (unpleasant) to 100 (pleasant).
Perceptual ratings of roughness
The perceptual rating of the perceived roughness of different applied stimuli will be gained to determine the overt sensations induced by the stimulation. The scale is a visual analog scale with the anchors 'smooth' and 'rough' that outputs a scale of 0 (smooth) to 100 (rough).
Perceptual ratings of intensity
The perceptual rating of the perceived intensity of different applied stimuli will be gained to determine the overt sensations induced by the stimulation. The scale is a visual analog scale with the anchors 'not al all intense' and 'intense' that outputs a scale of 0 (not at all intense) to 100 (intense).
Full Information
NCT ID
NCT05548322
First Posted
September 2, 2022
Last Updated
September 16, 2022
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT05548322
Brief Title
Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses
Acronym
TACTHUM
Official Title
Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 3, 2022 (Anticipated)
Primary Completion Date
October 2, 2032 (Anticipated)
Study Completion Date
November 2, 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Determine how tactile mechanoreceptors encode the texture of natural surfaces during passive and active exploration.
Investigate how our sense of touch varies with emotional state.
Explore what happens to our sense of touch when we explore surfaces at different temperatures.
Understand the origin of our perception of humidity.
Investigate differences in the encoding of tactile information with age.
Determine the perceptions generated by the stimulation of single tactile afferents.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatosensory Disorders, Amputation, Tactile Disorders, Aging, Prosthesis User
Keywords
Touch, Temperature, Somarosensation, Prosthetics, Microneurography, Tactile, Mechanoreceptor
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will take part in experiments that investigate the seven arms of the study. Participants with an amputation will only take part in arm 7. Healthy participants may take part in one to six arms (arms 1-6). However, this is dependent upon the recordings found in the experiment.
Masking
Participant
Allocation
Non-Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study of tactile afferent responses to natural surfaces
Arm Type
Experimental
Arm Title
Modulation of touch according to the emotional state
Arm Type
Experimental
Arm Title
Effect of temperature on tactile sensitivity
Arm Type
Experimental
Arm Title
Origin of wetness perception
Arm Type
Experimental
Arm Title
Aging and tactile sensitivity
Arm Type
Experimental
Arm Title
Tactile perceptions induced by the stimulation of single sensory fibers
Arm Type
Experimental
Arm Title
Study of tactile feedback after amputation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Different surfaces to be touched
Intervention Description
The participant will touch various different surfaces and textures, including ones of different temperature and including solids and liquids.
Intervention Type
Behavioral
Intervention Name(s)
Emotional state change
Intervention Description
The emotional state of the participant will be modulated by listening to music.
Intervention Type
Device
Intervention Name(s)
Electrical stimulation
Intervention Description
The participant will receive electrical stimulation of single nerve fibers (a few microamps) to artificially excite an individual afferent.
Primary Outcome Measure Information:
Title
Microneurography recording
Description
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.
Time Frame
Measured during the experiment (single event, max. 6 hours), during stimulation intervention
Secondary Outcome Measure Information:
Title
Electrodermal response
Description
Electrodermal response will be recorded from electrodes attached to the glabrous skin, to register further effects of the stimulation on the body.
Time Frame
Measured during the experiment (single event, max. 6 hours), during stimulation intervention
Title
Heart rate
Description
Heart rate will be recorded via three electrodes on the skin, to register further effects of the stimulation on the body.
Time Frame
Measured during the experiment (single event, max. 6 hours), during stimulation intervention
Title
Electromyography
Description
Electromyography (EMG) will be recorded from surface skin electrodes over the muscle, to register further effects of the stimulation on the body. From this recording, measures of the total activity (area under the curve) during a stimulation period and the frequency composition will be extracted.
Time Frame
Measured during the experiment (single event, max. 6 hours), during stimulation intervention
Title
Electroencephalography
Description
Electroencephalography (EEG) will be recorded from surface scalp skin using a 64 electrodes setup, to register further effects of the stimulation on brain responses. From this recording, measures of the event-related potentials to stimulation will be analyzed and the frequency composition (theta, alpha, beta, gamma) of the response will be extracted.
Time Frame
Measured during the experiment (single event, max. 6 hours), during stimulation intervention
Title
Perceptual ratings of pleasantness
Description
The perceptual rating of the perceived pleasantness of different applied stimuli will be gained to determine the overt sensations induced by the stimulation. The scale is a visual analog scale with the anchors 'pleasant' and 'unpleasant' that outputs a scale of 0 (unpleasant) to 100 (pleasant).
Time Frame
Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention
Title
Perceptual ratings of roughness
Description
The perceptual rating of the perceived roughness of different applied stimuli will be gained to determine the overt sensations induced by the stimulation. The scale is a visual analog scale with the anchors 'smooth' and 'rough' that outputs a scale of 0 (smooth) to 100 (rough).
Time Frame
Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention
Title
Perceptual ratings of intensity
Description
The perceptual rating of the perceived intensity of different applied stimuli will be gained to determine the overt sensations induced by the stimulation. The scale is a visual analog scale with the anchors 'not al all intense' and 'intense' that outputs a scale of 0 (not at all intense) to 100 (intense).
Time Frame
Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rochelle Ackerley, PhD
Phone
0033413550888
Email
rochelle.ackerley@univ-amu.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Marc Aimonetti, PhD
Phone
0033413550833
Email
jean-marc.aimonetti@univ-amu.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Elzeiere, MD
Organizational Affiliation
CNRS - Aix-Marseille University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rochelle Ackerley, PhD
Organizational Affiliation
CNRS - Aix-Marseille University
Official's Role
Study Director
Facility Information:
Facility Name
CNRS - Aix-Marseille University UMR7291
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rochelle Ackerley, PhD
Email
rochelle.ackerley@univ-amu.fr
First Name & Middle Initial & Last Name & Degree
Jean-Marc Aimonetti, PhD
Email
jean-marc.aimonetti@univ-amu.fr
First Name & Middle Initial & Last Name & Degree
Rochelle Ackerley, PhD
First Name & Middle Initial & Last Name & Degree
Jean-Marc Aimonetti, PhD
Facility Name
Hôpital HIA Lavéran
City
Marseille
ZIP/Postal Code
13013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Théfenne, MD
Email
laurentthefenne@orange.fr
First Name & Middle Initial & Last Name & Degree
Rochelle Ackerley, PhD
Email
rochelle.ackerley@univ-amu.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses
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