Physiological Responses to Upper Limb NMES
2026년 6월 3일 업데이트: Kieron.Day
Exploring Local Physiological Changes in the Arm During NMES Using the Firefly® Device
The primary objective of this study is to explore the application of the Firefly® device for delivering NMES to anatomically defined regions of the upper limb and to observe associated physiological changes.
Specifically, the study will assess alterations in arterial and venous blood flow, as well as local muscle oxygen saturation, as potential indicators of muscle perfusion during NMES.
연구 개요
상세 설명
Participants will undergo NMES using the Firefly® device, applied to two predefined regions of the upper limb: one targeting the anterior arm nerve bundle (a collective term referring to motor and sensory nerves within the anterior and medial compartments of the upper arm, including the musculocutaneous and adjacent (median, medial cutaneous, ulnar and radial) nerves, and the other targeting the median nerve in the proximal forearm.
Vascular responses will be assessed at two sites, the brachial artery and axillary vein, using Doppler ultrasound. For each nerve-vascular site pairing, NMES will alternate between stimulation OFF and ON conditions (10 OFF and 10 ON cycles), comprising one stimulation block of approximately 20 minutes. Each participant will complete four stimulation blocks in total.
During both ON and OFF phases, blood flow volume and haemodynamic parameters, including peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI), will be recorded. Additionally, local muscle oxygen saturation (SmO₂) will be continuously monitored using functional near-infrared spectroscopy (fNIRS) to assess tissue-level physiological changes.
The total study participation time per individual is approximately 2 hours.
연구 유형
중재적
등록 (실제)
10
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Buckinghamshire
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High Wycombe, Buckinghamshire, 영국, HP11 1JX
- Firstkind
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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
아니
설명
Inclusion Criteria:
- Aged 18 to 45 years (inclusive)
- No known history of vascular or neurological conditions affecting the upper extremities
- Able to read, understand, and communicate in English to ensure informed consent and safe participation in the study
Exclusion Criteria:
- Presence of any condition that contraindicates the use of neuromuscular electrical stimulation (e.g., implanted pacemaker, epilepsy)
- Current or recent injury to the upper limbs that may interfere with stimulation or measurement
- Anatomical variations in the brachial artery or axillary vein, specifically vascular branching outside expected anatomical locations, as identified by ultrasound, which may impair accurate blood flow measurement or device placement
- Currently participating in another interventional or physiological research study or having done so within the past 30 days.
- Currently pregnant
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Single experimental arm: Firefly NMES
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Firefly NMES device applied to the upper limb during a single-visit exploratory pysiological study
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in upper-limb blood flow volume during NMES (ON vs OFF)
기간: During single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles
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Within-subject change in upper-limb blood flow volume (mL/min) measured using Doppler ultrasound during neuromuscular electrical stimulation (NMES) delivered via the Firefly device, comparing stimulation ON versus OFF conditions.
Measurements will be collected across repeated stimulation cycles at predefined upper-limb stimulation zones and vascular assessment sites.
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During single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles
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Change in upper-limb peak systolic velocity during NMES (ON vs OFF)
기간: During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
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Within-subject change in upper-limb peak systolic velocity (PSV; cm/s) measured using Doppler ultrasound during NMES delivered via the Firefly device, comparing stimulation ON versus OFF conditions across repeated stimulation cycles at predefined upper-limb stimulation zones and vascular assessment sites.
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During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
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Change in upper-limb end-diastolic velocity during NMES (ON vs OFF)
기간: During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
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Within-subject change in upper-limb end-diastolic velocity (EDV; cm/s) measured using Doppler ultrasound during NMES delivered via the Firefly device, comparing stimulation ON versus OFF conditions across repeated stimulation cycles at predefined upper-limb stimulation zones and vascular assessment sites.
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During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
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Change in upper-limb resistive index during NMES (ON vs OFF)
기간: During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
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Within-subject change in upper-limb resistive index (RI; unitless ratio) derived from Doppler ultrasound measurements during NMES delivered via the Firefly device, comparing stimulation ON versus OFF conditions across repeated stimulation cycles at predefined upper-limb stimulation zones and vascular assessment sites.
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During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
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Change in upper-limb muscle oxygen saturation during NMES (ON vs OFF)
기간: During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
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Within-subject change in upper-limb muscle oxygen saturation (SmO₂; %) measured continuously using functional near-infrared spectroscopy (fNIRS) during NMES delivered via the Firefly device, comparing stimulation ON versus OFF conditions across repeated stimulation cycles at predefined upper-limb stimulation zones and assessment sites.
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During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of adverse events and device-related effects
기간: During single study visit (approximately 2 hours)
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Number and type of adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs), and device deficiencies observed during study participation.
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During single study visit (approximately 2 hours)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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)
2025년 9월 19일
기본 완료 (실제)
2025년 10월 3일
연구 완료 (실제)
2025년 10월 3일
연구 등록 날짜
최초 제출
2026년 4월 10일
QC 기준을 충족하는 최초 제출
2026년 6월 3일
처음 게시됨 (실제)
2026년 6월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 3일
마지막으로 확인됨
2026년 6월 1일
추가 정보
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. .
건강한 성인 참가자에 대한 임상 시험
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Vigil Neuroscience, Inc.종료됨ALSP미국, 브라질, 캐나다, 독일, 네덜란드, 영국
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Vigil Neuroscience, Inc.종료됨ALSP미국, 프랑스, 독일, 네덜란드, 영국
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Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin모병부신백질이영양증 | 부신척수신경병증 | 이색성 백질이영양증 | Axonal Spheroids와 Pigmented Glia를 동반한 Adult-Onset Leukoencephalopathy프랑스
Firefly NMES device에 대한 임상 시험
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Hospital Universitário Professor Edgard Santos아직 모집하지 않음간경화 | 근감소증
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Bursa Yuksek Ihtisas Training and Research Hospital완전한
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University Hospital, GenevaEcole Polytechnique Fédérale de Lausanne; Clinique Romande de Readaptation완전한
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Istanbul Arel UniversityHacettepe University; Istinye University초대로 등록