NCT07691957 Microneurography and Intraneural Microstimulation for Upper Limb Sensory Investigation in Healthy and Amputee Subjects
| NCT ID | NCT07691957 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero, Universitaria Pisana |
| Condition | Upper Limb Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-04 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-03-04 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this experimental study is to investigate the somatosensory system through intraneural recording and stimulation of the median nerve in healthy volunteers and participants with upper-limb amputation. The main questions it aims to answer are: * How does median nerve activity encode tactile perception during different types of mechanical tactile stimulation in healthy subjects? * How can tactile information be artificially encoded and restored through intraneural microstimulation in both healthy subjects and upper-limb amputee participants? How rich and functionally meaningful is the restored sensory information? * What are the neurophysiological mechanisms underlying tactile stimulus processing and the associated patterns of brain activation during tactile stimulation? Participants will undergo median nerve recordings using microneurography during controlled mechanical tactile stimulation, as well as intraneural microstimulation with specific patterns to evoke near-natural tactile sensations. They will perform perceptual reporting tasks related to stimulus type, intensity, and localization, as well as psychophysical tests under different stimulation conditions. When possible, they will also undergo non-invasive recordings of brain activity using electroencephalography during sensory stimulation.
Eligibility Criteria
Inclusion Criteria: Healthy participants * Age between 18-60 years, of any sex * Signed informed consent * No neurological diseases * Presence of both intact upper limbs * Normal language, visuospatial, and general intellectual abilities, assessed using the Wechsler Adult Intelligence Scale-Revised (WAIS-R) (Appendix 1) Amputee participants * Age between 18-60 years, of any sex * Signed informed consent * Upper-limb amputation (transradial or hand amputation) * Stable amputation for at least one year * Normal language, visuospatial, and general intellectual abilities, assessed using the Wechsler Adult Intelligence Scale-Revised (WAIS-R) (Appendix 1) * Evidence of residual peripheral nerve function in the stump, based on nerve conduction studies as documented in clinical records Exclusion Criteria: Healthy participants * Conditions affecting perceptual abilities * Inability to provide informed consent * Pregnancy or breastfeeding (self-reported) * Clinical conditions that, in the judgment of the investigator responsible for recruitment, may interfere with microneurography, microstimulation, and EEG procedures * Current or past substance abuse * Brain injury with residual motor impairment * Depression * Presence of neurological or musculoskeletal disorders * Diabetes mellitus * Current or previous dermatological conditions * Morphological nerve abnormalities, as indicated by ultrasound or MRI findings in clinical records * Upper-limb amputation Amputee participants * Psychological and/or cognitive disorders * Inability to provide informed consent * Pregnancy or breastfeeding (self-reported) * Clinical conditions that, in the judgment of the investigator responsible for recruitment, may interfere with microneurography, microstimulation, and EEG procedures * Current or past substance abuse * Brain injury with residual motor impairment * Depression * Presence of neurological or musculoskeletal disorders * Diabetes mellitus * Current or previous dermatological conditions * Morphological nerve abnormalities, as indicated by ultrasound or MRI findings in clinical records * Bilateral upper-limb amputation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07691957 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Upper Limb Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07691957 currently recruiting?
Yes, NCT07691957 is actively recruiting participants. Contact the research team at stefano.taddei@unipi.it for enrollment information.
Where is the NCT07691957 trial being conducted?
This trial is being conducted at Pisa, Italy.
Who is sponsoring the NCT07691957 clinical trial?
NCT07691957 is sponsored by Azienda Ospedaliero, Universitaria Pisana. The trial plans to enroll 100 participants.