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RecruitingNCT05548322TACTHUMUpdated Mar 4, 2026

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

An interventional study of Different surfaces to be touched and Emotional state change in Somatosensory Disorders, Amputation and Tactile Disorders, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Recruiting at 2 sites in France. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-04.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Non-randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Somatosensory Disorders
  • Amputation
  • Tactile Disorders
  • Aging
  • Prosthesis User

Keywords

  • Touch
  • Temperature
  • Somarosensation
  • Prosthetics
  • Microneurography
  • Tactile
  • Mechanoreceptor
03

In context

Somatosensory Disorders

65 studies on the registry are indexed under Somatosensory Disorders; 8 are open to participants now.

This study's planned enrollment of 210 is above the median of 40 across 45 interventional studies indexed under Somatosensory Disorders.

Browse Somatosensory Disorders studies →

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    Study of tactile afferent responses to natural surfaces

    Device: Different surfaces to be touched

  • Experimental
    Modulation of touch according to the emotional state

    Device: Different surfaces to be touched · Behavioral: Emotional state change

  • Experimental
    Effect of temperature on tactile sensitivity

    Device: Different surfaces to be touched

  • Experimental
    Origin of wetness perception

    Device: Different surfaces to be touched

  • Experimental
    Aging and tactile sensitivity

    Device: Different surfaces to be touched · Behavioral: Emotional state change · Device: Electrical stimulation

  • Experimental
    Tactile perceptions induced by the stimulation of single sensory fibers

    Device: Electrical stimulation

  • Experimental
    Study of tactile feedback after amputation

    Device: Different surfaces to be touched · Device: Electrical stimulation

Interventions

  • DeviceDifferent surfaces to be touched

    The participant will touch various different surfaces and textures, including ones of different temperature and including solids and liquids.

  • BehavioralEmotional state change

    The emotional state of the participant will be modulated by listening to music.

  • DeviceElectrical stimulation

    The participant will receive electrical stimulation of single nerve fibers (a few microamps) to artificially excite an individual afferent.

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. Electrodermal response

    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

  2. Heart rate

    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

  3. 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.

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

  4. 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.

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

  5. 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).

    Time frame: Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention

  6. 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).

    Time frame: Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention

  7. 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).

    Time frame: Measured during the experiment (single event, max. 6 hours), directly after the stimulation intervention

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05548322
Responsible party
Sponsor
First posted
Sep 21, 2022
Start date
Apr 15, 2024
Primary completion
Oct 2, 2034 (estimated)
Completion
Nov 2, 2034 (estimated)
Last update
Mar 4, 2026

Study contacts

Rochelle Ackerley, PhD
Contact
rochelle.ackerley@univ-amu.fr
0033413550888
Jean-Marc Aimonetti, PhD
Contact
jean-marc.aimonetti@univ-amu.fr
0033413550833
Maya Elzeiere, MD
principal investigator · CNRS - Aix-Marseille University
Rochelle Ackerley, PhD
study director · CNRS - Aix-Marseille University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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