Somatosensory DisordersTACTHUMNCT05548322
Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses
A study testing Different surfaces to be touched, Emotional state change and Electrical stimulation in people with Somatosensory Disorders and Amputation, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Somatosensory Disorders, Amputation, Tactile Disorders
- What is being tested?
- Different surfaces to be touched, Emotional state change and Electrical stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesFrance
- Study dates
- 15 Apr 2024to 2 Nov 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CNRS - Aix-Marseille University UMR7291
Marseille, 13003
Rochelle Ackerley, PhD, rochelle.ackerley@univ-amu.fr
Jean-Marc Aimonetti, PhD, jean-marc.aimonetti@univ-amu.fr
- Not yet recruiting
Hôpital HIA Lavéran
Marseille, 13013
Laurent Théfenne, MD, laurentthefenne@orange.fr
Rochelle Ackerley, PhD, rochelle.ackerley@univ-amu.fr
About this study
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:
Read more
- 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.
- Conditions
- Somatosensory Disorders, Amputation, Tactile Disorders, Aging, Prosthesis User
- Being tested
- Different surfaces to be touched, Emotional state change, Electrical stimulation
- Keywords
- Touch, Temperature, Somarosensation, Prosthetics, Microneurography, Tactile, Mechanoreceptor
- Medical subject headings
- Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different surfaces to be touchedDevice
The participant will touch various different surfaces and textures, including ones of different temperature and including solids and liquids.
Emotional state changeBehavioural
The emotional state of the participant will be modulated by listening to music.
Electrical stimulationDevice
The participant will receive electrical stimulation of single nerve fibers (a few microamps) to artificially excite an individual afferent.
| Study group | Role | What they receive |
|---|---|---|
| Study of tactile afferent responses to natural surfaces | Experimental | Not described Receives: Device: Different surfaces to be touched |
| Modulation of touch according to the emotional state | Experimental | Not described Receives: Device: Different surfaces to be touched; Behavioral: Emotional state change |
| Effect of temperature on tactile sensitivity | Experimental | Not described Receives: Device: Different surfaces to be touched |
| Origin of wetness perception | Experimental | Not described Receives: Device: Different surfaces to be touched |
| Aging and tactile sensitivity | Experimental | Not described Receives: Device: Different surfaces to be touched; Behavioral: Emotional state change; Device: Electrical stimulation |
| Tactile perceptions induced by the stimulation of single sensory fibers | Experimental | Not described Receives: Device: Electrical stimulation |
| Study of tactile feedback after amputation | Experimental | Not described Receives: Device: Different surfaces to be touched; Device: Electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measured during the experiment (single event, max. 6 hours), during stimulation intervention
Secondary outcomes (7)
Electrodermal response
Electrodermal response will be recorded from electrodes attached to the glabrous skin, to register further effects of the stimulation on the body.
Measured: Measured during the experiment (single event, max. 6 hours), during stimulation intervention
Heart rate
Heart rate will be recorded via three electrodes on the skin, to register further effects of the stimulation on the body.
Measured: Measured during the experiment (single event, max. 6 hours), during stimulation intervention
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.
Measured: Measured during the experiment (single event, max. 6 hours), during stimulation intervention
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.
Measured: Measured during the experiment (single event, max. 6 hours), during stimulation intervention
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).
Measured: Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention
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).
Measured: Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention
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).
Measured: Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start15 Apr 2024
- Primary completion2 Oct 2034 (estimated)
- Study completion2 Nov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatosensory DisordersStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Maya Elzeiere, MD, Principal investigator, CNRS - Aix-Marseille UniversityRochelle Ackerley, PhD, Study director, CNRS - Aix-Marseille University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548322
- Sponsor's protocol ID
- C21-19
- Other IDs
- 2021-A01604-37
- Acronym
- TACTHUM
- Status last verified
- Mar 2026
- First submitted
- 2 Sep 2022
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses
- ClinicalTrials.gov ID
- NCT05548322
- Acronym / sponsor ID
- TACTHUM / C21-19
- Conditions
- Somatosensory Disorders, Amputation, Tactile Disorders, Aging, Prosthesis User
- Keywords
- Touch, Temperature, Somarosensation, Prosthetics, Microneurography, Tactile, Mechanoreceptor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 2 Oct 2034 (estimated)
- Study completion
- 2 Nov 2034 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 7
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study of tactile afferent responses to natural surfaces | Experimental | Device: Different surfaces to be touched |
| Modulation of touch according to the emotional state | Experimental | Device: Different surfaces to be touched, Behavioral: Emotional state change |
| Effect of temperature on tactile sensitivity | Experimental | Device: Different surfaces to be touched |
| Origin of wetness perception | Experimental | Device: Different surfaces to be touched |
| Aging and tactile sensitivity | Experimental | Device: Different surfaces to be touched, Behavioral: Emotional state change, Device: Electrical stimulation |
| Tactile perceptions induced by the stimulation of single sensory fibers | Experimental | Device: Electrical stimulation |
| Study of tactile feedback after amputation | Experimental | Device: Different surfaces to be touched, Device: Electrical stimulation |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different surfaces to be touchedThe participant will touch various different surfaces and textures, including ones of different temperature and including solids and liquids. | Device | Aging and tactile sensitivity, Effect of temperature on tactile sensitivity, Modulation of touch according to the emotional state, Origin of wetness perception, Study of tactile afferent responses to natural surfaces, Study of tactile feedback after amputation |
| Emotional state changeThe emotional state of the participant will be modulated by listening to music. | Behavioural | Aging and tactile sensitivity, Modulation of touch according to the emotional state |
| Electrical stimulationThe participant will receive electrical stimulation of single nerve fibers (a few microamps) to artificially excite an individual afferent. | Device | Aging and tactile sensitivity, Study of tactile feedback after amputation, Tactile perceptions induced by the stimulation of single sensory fibers |
Primary outcome
Microneurography recording
Time frame: 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.
7 secondary outcomes
Electrodermal response
Time frame: Measured during the experiment (single event, max. 6 hours), during stimulation intervention
Heart rate
Time frame: Measured during the experiment (single event, max. 6 hours), during stimulation intervention
Electromyography
Time frame: Measured during the experiment (single event, max. 6 hours), during stimulation intervention
Electroencephalography
Time frame: Measured during the experiment (single event, max. 6 hours), during stimulation intervention
Perceptual ratings of pleasantness
Time frame: Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention
Perceptual ratings of roughness
Time frame: Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention
Perceptual ratings of intensity
Time frame: Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maya Elzeiere, MD principal investigator
CNRS - Aix-Marseille University
Rochelle Ackerley, PhD study director
CNRS - Aix-Marseille University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different surfaces to be touched, Emotional state change and Electrical stimulation in people with Somatosensory Disorders and Amputation, run by Institut National de la Santé Et de la Recherche Médicale, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rochelle Ackerley, PhD (0033413550888, rochelle.ackerley@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microneurography recording (time frame: Measured during the experiment (single event, max. 6 hours), during stimulation intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.