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

2026년 7월 7일 업데이트: Stefano Taddei, Azienda Ospedaliero, Universitaria Pisana

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Pisa
      • Pisa, Pisa, 이탈리아, 56127
        • 모병
        • Laboratorio Congiunto di Microneurografia e Microneurostimolazione
        • 연락하다:
        • 수석 연구원:
          • Calogero Maria Oddo, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Microneurographic Session
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.
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.
실험적: Intraneural Microstimulation Session
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.
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mechanoreceptor identification success rate
기간: 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 (%).
During the experimental protocol (up to 3 hours)
Mechanoreceptor classification accuracy
기간: 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 (%).
During the experimental session (up to 3 hours)
Peripheral afferent firing rate during tactile stimulation
기간: 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.
During the experimental session (up to 3 hours)
Tactile mechanical detection threshold
기간: 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.
During the experimental session (up to 3 hours)
Receptive field size of mechanoreceptive afferents
기간: 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.
During the experimental session (up to 3 hours)
Perceived sensory perception during intraneural microstimulation
기간: 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.
During the experimental protocol (up to 3 hours)
Perceived intensity of tactile sensations elicited during intraneural microstimulation
기간: 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.
During the experimental protocol (up to 3 hours)
Perceived location of tactile sensations elicited during intraneural microstimulation
기간: 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.
During the experimental protocol (up to 3 hours)
Tactile discrimination performance
기간: 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.
During the experimental session (up to 3 hours)

2차 결과 측정

결과 측정
측정값 설명
기간
Event-related potential amplitude during intraneural microstimulation
기간: During the experimental protocol (up to 3 hours)
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.
During the experimental protocol (up to 3 hours)
Event-related potential latency during intraneural microstimulation
기간: During the experimental protocol (up to 3 hours)
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.
During the experimental protocol (up to 3 hours)
EEG spectral power modulation during intraneural microstimulation
기간: During the experimental session (up to 3 hours)
Changes in EEG spectral power recorded using 128-channel EEG during intraneural microstimulation expressed as spectral power (µV²) or percentage change from baseline (%)
During the experimental session (up to 3 hours)
Decoding accuracy of tactile stimulation conditions from EEG signals
기간: During the experimental session (up to 3 hours)
Machine learning-based classification of tactile stimulation conditions using EEG-derived features (classification accuracy %)
During the experimental session (up to 3 hours)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 3월 4일

기본 완료 (추정된)

2026년 12월 31일

연구 완료 (추정된)

2026년 12월 31일

연구 등록 날짜

최초 제출

2026년 5월 21일

QC 기준을 충족하는 최초 제출

2026년 7월 7일

처음 게시됨 (실제)

2026년 7월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 7일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 18385_TADDEI
  • TUNEBEAM_MICROAMP (기타 식별자: Tuscany Region)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Upon publication of results, anonymized data and analysis code will be shared to ensure reproducibility.

IPD 공유 기간

Upon publication of results

IPD 공유 액세스 기준

Data and code will be available for research purposes upon request to authors.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .