Microneurography and Intraneural Microstimulation for Upper Limb Sensory Investigation in Healthy and Amputee Subjects

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAzienda Ospedaliero, Universitaria Pisana

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Age between 18-60 years, of any sex

Signed informed consent

No neurological diseases

Presence of both intact upper limbs

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Microneurography

    Procedure/Surgery

    Microneurography is a minimally invasive neurophysiological technique that allows direct recording of the electrical activity of single peripheral nerve fibers using specific microelectrodes inserted into the nerve.

  • Intraneural Microstimulation

    Procedure/Surgery

    Intraneural microstimulation is a minimally invasive neurophysiological technique in which small electrical currents are delivered through a microelectrode inserted into a peripheral nerve to selectively activate nerve fibers and evoke sensory perceptions.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Microneurographic SessionExperimental treatment 1 intervention
Group B: Intraneural Microstimulation SessionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mechanoreceptor identification success rate

The proportion of experimental sessions in which a single mechanoreceptive afferent is successfully isolated and identified using MNG during controlled mechanical tactile stimulation, expressed as the percentage of successful recordings (%).

Time frame
During the experimental protocol (up to 3 hours)
2

Mechanoreceptor classification accuracy

The accuracy of mechanoreceptor type classification (e.g., SA1, SA2, RA, PC) based on MNG recordings during mechanical tactile stimulation, expressed as the percentage of correctly classified receptors (%).

Time frame
During the experimental session (up to 3 hours)
3

Peripheral afferent firing rate during tactile stimulation

The mean firing rate (spikes/s) of mechanoreceptive afferents recorded by MNG during controlled mechanical tactile stimulation.

Time frame
During the experimental session (up to 3 hours)
4

Tactile mechanical detection threshold

The minimum stimulus intensity (expressed in grams of calibrated Von Frey Hairs) required to evoke a consistent neural response during mechanical tactile stimulation.

Time frame
During the experimental session (up to 3 hours)

Secondary outcomes

1

Event-related potential amplitude during intraneural microstimulation

Event-related potentials (ERPs) elicited by intraneural microstimulation and recorded using 128-channel EEG will be quantified by peak amplitude (µV) of stimulus-locked cortical responses.

Time frame
During the experimental protocol (up to 3 hours)
2

Event-related potential latency during intraneural microstimulation

Event-related potentials (ERPs) elicited by intraneural microstimulation and recorded using 128-channel EEG will be quantified by peak latency (ms) of stimulus-locked cortical responses.

Time frame
During the experimental protocol (up to 3 hours)
3

EEG spectral power modulation during intraneural microstimulation

Changes in EEG spectral power recorded using 128-channel EEG during intraneural microstimulation expressed as spectral power (µV²) or percentage change from baseline (%)

Time frame
During the experimental session (up to 3 hours)
4

Decoding accuracy of tactile stimulation conditions from EEG signals

Machine learning-based classification of tactile stimulation conditions using EEG-derived features (classification accuracy %)

Time frame
During the experimental session (up to 3 hours)

Other outcomes

Sponsors and contacts

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Azienda Ospedaliero, Universitaria Pisana

Lead sponsor

Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Collaborator