Exploring touch sensations to improve feedback in prosthetics
Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses
NA · Institut National de la Santé Et de la Recherche Médicale, France · NCT05548322
This study is testing how touch sensations can be improved in prosthetics to help amputees feel better and interact more naturally with their devices.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France (other gov) |
| Locations | 2 sites (Marseille and 1 other locations) |
| Trial ID | NCT05548322 on ClinicalTrials.gov |
What this trial studies
This project investigates how mechanoreceptors in the human body respond to various external stimuli to enhance our understanding of the somatosensory system. By examining the fundamental firing patterns of these receptors, the study aims to develop better sensory feedback mechanisms for prosthetic devices. Participants will experience different surfaces, emotional state changes, and electrical stimulation to assess their responses. The ultimate goal is to recreate the lost sensory input in amputees, improving their interaction with prosthetics.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 20 to 70, particularly those with unilateral upper or lower limb amputations lasting more than two years.
Not a fit: Patients with peripheral neuropathy, chronic pain, or those with a neurological or psychiatric history may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to more advanced prosthetic devices that provide realistic sensory feedback, significantly enhancing the quality of life for amputees.
How similar studies have performed: While there have been advancements in sensory feedback for prosthetics, this specific approach to understanding mechanoreceptor responses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Marseille and 1 other locations
- CNRS - Aix-Marseille University UMR7291 — Marseille, France (RECRUITING)
- Hôpital HIA Lavéran — Marseille, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Maya Elzeiere, MD — CNRS - Aix-Marseille University
- Study coordinator: Rochelle Ackerley, PhD
- Email: rochelle.ackerley@univ-amu.fr
- Phone: 0033413550888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Somatosensory Disorders, Amputation, Tactile Disorders, Aging, Prosthesis User, Touch, Temperature, Somarosensation