Upper Limb AmputationMICROAMPNCT07691957
Microneurography and Intraneural Microstimulation for Upper Limb Sensory Investigation in Healthy and Amputee Subjects
A study testing Microneurography and Intraneural Microstimulation in people with Upper Limb Amputation and Healthy Subjects, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Amputation, Healthy Subjects
- What is being tested?
- Microneurography and Intraneural Microstimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 4 Mar 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Laboratorio Congiunto di Microneurografia e Microneurostimolazione
Pisa, Pisa, 56127
Calogero Maria Oddo, PhD, +39 050 883111, calogero.oddo@santannapisa.it
Calogero Maria Oddo, PhD
About this study
Official title: Experimental Study to Investigate Sensory Control of the Upper Limb Through Microneurography and to Restore Near-natural Tactile Sensations Through Intraneural Microstimulation in Healthy and Amputee Subjects
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.
Read the detailed description
Participants will attend the laboratory where the entire research protocol will be conducted in a single visit lasting up to 4 hours.
Medical history and a physical examination will be collected. In participants with amputation, additional clinical information from previous neurological assessments will be reviewed (including medical records, nerve conduction velocity data, and ultrasound or MRI examinations required to verify inclusion/exclusion criteria). Psychometric tests will also be administered to assess language abilities, visuospatial skills, and general intelligence, ensuring that participants are able to understand and perform the experimental tasks. If inclusion and exclusion criteria are met, participants will undergo microneurography and/or intraneural microstimulation procedures. Participants will be seated comfortably, with the dominant arm (healthy volunteers) or the residual limb (participants with amputation) supported. A trained medical operator will identify the median nerve using external stimulation and/or ultrasound guidance to assist electrode insertion. The active electrode will be inserted into the nerve, while a reference electrode will be placed in the subcutaneous tissue a few centimeters away. Correct electrode placement will then be refined using intraneural stimulation. Once the nerve fascicle is reached, tactile stimulation of the hand will be used to identify single mechanoreceptive units. Final electrode placement will be confirmed by visual and auditory inspection of the neural signal. The median nerve activity must be clearly distinguishable from background activity when mechanical stimuli are applied to the skin. During electrode insertion, participants will be instructed to remain still until the procedure is completed. The intraneural microstimulation session, performed in both healthy volunteers and participants with upper-limb amputation, is preceded by peripheral neural recordings using microneurography during the presentation of tactile stimuli (e.g., Von Frey filaments). This step is used for accurate nerve localization and preliminary assessment of the receptors and their receptive fields. Once the neural target is identified, participants undergo intraneural stimulation involving the perception and recognition of artificially generated tactile stimuli. These stimuli are delivered via intraneural microstimulation and are derived from mechanoneural transduction, using a sensorized artificial finger interacting with different surfaces to encode surface-dependent tactile information. Participants will be asked to recognize different properties of the presented stimuli. During the tests, electroencephalographic (EEG) activity may be recorded using a 128-channel EEG system, synchronized with the onset of stimulation.
- Conditions
- Upper Limb Amputation, Healthy Subjects
- Being tested
- Microneurography, Intraneural Microstimulation
- Keywords
- Microneurography, Intraneural Microstimulation, Somatosensory System, Upper limb amputation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroneurographyProcedure or 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 MicrostimulationProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Microneurographic Session | Experimental | During MNG session, microneurographic signals are recorded while mechanical tactile stimuli (e.g., Von Frey filaments) are applied. This recording-only task is used to characterize the mechanoreceptor properties, including receptive field mapping, response type, and firing behavior. Receives: Procedure: Microneurography |
| Intraneural Microstimulation Session | Experimental | During INMS session, intraneural microstimulation is delivered via the microelectrode to evoke tactile sensations. Stimulation patterns are generated from sensor-based interactions with different surfaces and are used to assess tactile perception, including stimulus recognition, intensity, and localization in both healthy and amputee participants. Receives: Procedure: Intraneural Microstimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: During the experimental protocol (up to 3 hours)
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 (%).
Measured: During the experimental session (up to 3 hours)
Peripheral afferent firing rate during tactile stimulation
The mean firing rate (spikes/s) of mechanoreceptive afferents recorded by MNG during controlled mechanical tactile stimulation.
Measured: During the experimental session (up to 3 hours)
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.
Measured: During the experimental session (up to 3 hours)
Receptive field size of mechanoreceptive afferents
The spatial extent of skin area (mm²) eliciting neural responses during mechanical tactile stimulation mapped via MNG.
Measured: During the experimental session (up to 3 hours)
Perceived sensory perception during intraneural microstimulation
Participant-reported sensory percepts will be classified into predefined categories (e.g., pressure, vibration, tingling, tapping) and summarized as the frequency and percentage of each sensory class across stimulation conditions.
Measured: During the experimental protocol (up to 3 hours)
Perceived intensity of tactile sensations elicited during intraneural microstimulation
Participants will rate the perceived intensity of each evoked sensation using a numerical rating scale from 0 (no sensation) to 10 (maximum imaginable intensity). Mean and standard deviation (or median and interquartile range) will be reported for each stimulation condition.
Measured: During the experimental protocol (up to 3 hours)
Perceived location of tactile sensations elicited during intraneural microstimulation
Participants will indicate the anatomical location of each evoked sensation on a standardized hand map. Responses will be summarized as frequencies and percentages for each anatomical region.
Measured: During the experimental protocol (up to 3 hours)
Tactile discrimination performance
Discrimination performance will be assessed using a two-alternative forced-choice (2AFC) psychophysical paradigm during intraneural microstimulation. Performance will be quantified using the Elo rating system, a continuous score derived from pairwise stimulus comparisons. The Elo rating has no predefined minimum or maximum value. Higher Elo scores indicate greater discrimination performance.
Measured: During the experimental session (up to 3 hours)
Secondary outcomes (4)
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.
Measured: During the experimental protocol (up to 3 hours)
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.
Measured: During the experimental protocol (up to 3 hours)
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 (%)
Measured: During the experimental session (up to 3 hours)
Decoding accuracy of tactile stimulation conditions from EEG signals
Machine learning-based classification of tactile stimulation conditions using EEG-derived features (classification accuracy %)
Measured: During the experimental session (up to 3 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start4 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Upper Limb AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero, Universitaria Pisana
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Responsible party
- Principal investigator, Stefano Taddei, Azienda Ospedaliero, Universitaria Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691957
- Sponsor's protocol ID
- 18385_TADDEI
- Other IDs
- TUNEBEAM_MICROAMP
- Acronym
- MICROAMP
- Status last verified
- Jul 2026
- First submitted
- 21 May 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon publication of results, anonymized data and analysis code will be shared to ensure reproducibility.
Publications
Ackerley R, Watkins RH. Microneurography as a tool to study the function of individual C-fiber afferents in humans: responses from nociceptors, thermoreceptors, and mechanoreceptors. J Neurophysiol. 2018 Dec 1;120(6):2834-2846. doi: 10.1152/jn.00109.2018. Epub 2018 Sep 26.
PubMed 30256737Oddo CM, Raspopovic S, Artoni F, Mazzoni A, Spigler G, Petrini F, Giambattistelli F, Vecchio F, Miraglia F, Zollo L, Di Pino G, Camboni D, Carrozza MC, Guglielmelli E, Rossini PM, Faraguna U, Micera S. Intraneural stimulation elicits discrimination of textural features by artificial fingertip in intact and amputee humans. Elife. 2016 Mar 8;5:e09148. doi: 10.7554/eLife.09148.
PubMed 26952132Vallbo AB. Microneurography: how it started and how it works. J Neurophysiol. 2018 Sep 1;120(3):1415-1427. doi: 10.1152/jn.00933.2017. Epub 2018 Jun 20.
PubMed 29924706Statache M, Filosa M, Ballanti S, D'Alesio G, Di Salvo G, Camboni D, Oddo CM. Neuromorphic Touch Sensors for Pleasantness Encoding via Spike Patterns: A Bio-Inspired Artifical Fingertip for Restoring Affective Sensations. IEEE Sensors, 2024, Kobe, Japan. doi: 10.1109/SENSORS60989.2024.10784624.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study to Investigate Sensory Control of the Upper Limb Through Microneurography and to Restore Near-natural Tactile Sensations Through Intraneural Microstimulation in Healthy and Amputee Subjects
- ClinicalTrials.gov ID
- NCT07691957
- Acronym / sponsor ID
- MICROAMP / 18385_TADDEI
- Conditions
- Upper Limb Amputation, Healthy Subjects
- Keywords
- Microneurography, Intraneural Microstimulation, Somatosensory System, Upper limb amputation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero, Universitaria PisanaUniversity, hospital or other
- Collaborators
- Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will attend the laboratory where the entire research protocol will be conducted in a single visit lasting up to 4 hours.
Medical history and a physical examination will be collected. In participants with amputation, additional clinical information from previous neurological assessments will be reviewed (including medical records, nerve conduction velocity data, and ultrasound or MRI examinations required to verify inclusion/exclusion criteria). Psychometric tests will also be administered to assess language abilities, visuospatial skills, and general intelligence, ensuring that participants are able to understand and perform the experimental tasks. If inclusion and exclusion criteria are met, participants will undergo microneurography and/or intraneural microstimulation procedures. Participants will be seated comfortably, with the dominant arm (healthy volunteers) or the residual limb (participants with amputation) supported. A trained medical operator will identify the median nerve using external stimulation and/or ultrasound guidance to assist electrode insertion. The active electrode will be inserted into the nerve, while a reference electrode will be placed in the subcutaneous tissue a few centimeters away. Correct electrode placement will then be refined using intraneural stimulation. Once the nerve fascicle is reached, tactile stimulation of the hand will be used to identify single mechanoreceptive units. Final electrode placement will be confirmed by visual and auditory inspection of the neural signal. The median nerve activity must be clearly distinguishable from background activity when mechanical stimuli are applied to the skin. During electrode insertion, participants will be instructed to remain still until the procedure is completed. The intraneural microstimulation session, performed in both healthy volunteers and participants with upper-limb amputation, is preceded by peripheral neural recordings using microneurography during the presentation of tactile stimuli (e.g., Von Frey filaments). This step is used for accurate nerve localization and preliminary assessment of the receptors and their receptive fields. Once the neural target is identified, participants undergo intraneural stimulation involving the perception and recognition of artificially generated tactile stimuli. These stimuli are delivered via intraneural microstimulation and are derived from mechanoneural transduction, using a sensorized artificial finger interacting with different surfaces to encode surface-dependent tactile information. Participants will be asked to recognize different properties of the presented stimuli. During the tests, electroencephalographic (EEG) activity may be recorded using a 128-channel EEG system, synchronized with the onset of stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneurographic Session | Experimental | Procedure: MicroneurographyDuring MNG session, microneurographic signals are recorded while mechanical tactile stimuli (e.g., Von Frey filaments) are applied. This recording-only task is used to characterize the mechanoreceptor properties, including receptive field mapping, response type, and firing behavior. |
| Intraneural Microstimulation Session | Experimental | Procedure: Intraneural MicrostimulationDuring INMS session, intraneural microstimulation is delivered via the microelectrode to evoke tactile sensations. Stimulation patterns are generated from sensor-based interactions with different surfaces and are used to assess tactile perception, including stimulus recognition, intensity, and localization in both healthy and amputee participants. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy participants
- Age between 18-60 years, of any sex
- Signed informed consent
- No neurological diseases
- Presence of both intact upper limbs
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroneurographyMicroneurography 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. | Procedure or surgery | Microneurographic Session |
| Intraneural MicrostimulationIntraneural 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. | Procedure or surgery | Intraneural Microstimulation Session |
Primary outcome
Mechanoreceptor identification success rate
Time frame: During the experimental protocol (up to 3 hours)
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 (%).
Mechanoreceptor classification accuracy
Time frame: During the experimental session (up to 3 hours)
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 (%).
Peripheral afferent firing rate during tactile stimulation
Time frame: During the experimental session (up to 3 hours)
The mean firing rate (spikes/s) of mechanoreceptive afferents recorded by MNG during controlled mechanical tactile stimulation.
Tactile mechanical detection threshold
Time frame: During the experimental session (up to 3 hours)
The minimum stimulus intensity (expressed in grams of calibrated Von Frey Hairs) required to evoke a consistent neural response during mechanical tactile stimulation.
Receptive field size of mechanoreceptive afferents
Time frame: During the experimental session (up to 3 hours)
The spatial extent of skin area (mm²) eliciting neural responses during mechanical tactile stimulation mapped via MNG.
Perceived sensory perception during intraneural microstimulation
Time frame: During the experimental protocol (up to 3 hours)
Participant-reported sensory percepts will be classified into predefined categories (e.g., pressure, vibration, tingling, tapping) and summarized as the frequency and percentage of each sensory class across stimulation conditions.
Perceived intensity of tactile sensations elicited during intraneural microstimulation
Time frame: During the experimental protocol (up to 3 hours)
Participants will rate the perceived intensity of each evoked sensation using a numerical rating scale from 0 (no sensation) to 10 (maximum imaginable intensity). Mean and standard deviation (or median and interquartile range) will be reported for each stimulation condition.
Perceived location of tactile sensations elicited during intraneural microstimulation
Time frame: During the experimental protocol (up to 3 hours)
Participants will indicate the anatomical location of each evoked sensation on a standardized hand map. Responses will be summarized as frequencies and percentages for each anatomical region.
Tactile discrimination performance
Time frame: During the experimental session (up to 3 hours)
Discrimination performance will be assessed using a two-alternative forced-choice (2AFC) psychophysical paradigm during intraneural microstimulation. Performance will be quantified using the Elo rating system, a continuous score derived from pairwise stimulus comparisons. The Elo rating has no predefined minimum or maximum value. Higher Elo scores indicate greater discrimination performance.
4 secondary outcomes
Event-related potential amplitude during intraneural microstimulation
Time frame: During the experimental protocol (up to 3 hours)
Event-related potential latency during intraneural microstimulation
Time frame: During the experimental protocol (up to 3 hours)
EEG spectral power modulation during intraneural microstimulation
Time frame: During the experimental session (up to 3 hours)
Decoding accuracy of tactile stimulation conditions from EEG signals
Time frame: During the experimental session (up to 3 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 30256737Ackerley R, Watkins RH. Microneurography as a tool to study the function of individual C-fiber afferents in humans: responses from nociceptors, thermoreceptors, and mechanoreceptors. J Neurophysiol. 2018 Dec 1;120(6):2834-2846. doi: 10.1152/jn.00109.2018. Epub 2018 Sep 26.
- Background: PubMed 26952132Oddo CM, Raspopovic S, Artoni F, Mazzoni A, Spigler G, Petrini F, Giambattistelli F, Vecchio F, Miraglia F, Zollo L, Di Pino G, Camboni D, Carrozza MC, Guglielmelli E, Rossini PM, Faraguna U, Micera S. Intraneural stimulation elicits discrimination of textural features by artificial fingertip in intact and amputee humans. Elife. 2016 Mar 8;5:e09148. doi: 10.7554/eLife.09148.
- Background: PubMed 29924706Vallbo AB. Microneurography: how it started and how it works. J Neurophysiol. 2018 Sep 1;120(3):1415-1427. doi: 10.1152/jn.00933.2017. Epub 2018 Jun 20.
- Results publicationStatache M, Filosa M, Ballanti S, D'Alesio G, Di Salvo G, Camboni D, Oddo CM. Neuromorphic Touch Sensors for Pleasantness Encoding via Spike Patterns: A Bio-Inspired Artifical Fingertip for Restoring Affective Sensations. IEEE Sensors, 2024, Kobe, Japan. doi: 10.1109/SENSORS60989.2024.10784624.
- Individual participant dataSharing planned: Yes. Upon publication of results, anonymized data and analysis code will be shared to ensure reproducibility.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneurography and Intraneural Microstimulation in people with Upper Limb Amputation and Healthy Subjects, run by Azienda Ospedaliero, Universitaria Pisana at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefano Taddei (+39 050993699, stefano.taddei@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanoreceptor identification success rate (time frame: During the experimental protocol (up to 3 hours)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07691957, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.