Microneurography and Intraneural Microstimulation for Upper Limb Sensory Investigation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses microneurography to record nerve activity and intraneural microstimulation to evoke tactile sensations in the median nerve of healthy volunteers and upper-limb amputees. Participants undergo a single laboratory visit of up to four hours, including medical history, exams, and psychometric testing to ensure suitability. The research seeks to understand tactile encoding, patterns of brain activation, and the potential for restoring meaningful sensory information through targeted nerve stimulation. Electrode placement is guided by ultrasound and neurophysiological verification to identify single mechanoreceptive units. All procedures are performed by trained operators with appropriate monitoring and safety controls.

Why it matters

Who can join: the full rules

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

Where it's running

• Laboratorio Congiunto di Microneurografia e Microneurostimolazione
  Pisa, Pisa, Italy Recruiting

Study contacts

• Study coordinator: Stefano Taddei
• Email: stefano.taddei@unipi.it
• Phone: +39 050993699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.