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Physiological Responses to Upper Limb NMES

2026年6月3日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 英国
    • Buckinghamshire
      • High Wycombe、Buckinghamshire、英国、HP11 1JX
        • Firstkind

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Single experimental arm: Firefly NMES
设备：Firefly NMES device
Firefly NMES device applied to the upper limb during a single-visit exploratory pysiological study

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in upper-limb blood flow volume during NMES (ON vs OFF)
大体时间：During single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles
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.
During single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles
Change in upper-limb peak systolic velocity during NMES (ON vs OFF)
大体时间：During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
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.
During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
Change in upper-limb end-diastolic velocity during NMES (ON vs OFF)
大体时间：During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
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.
During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
Change in upper-limb resistive index during NMES (ON vs OFF)
大体时间：During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
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.
During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
Change in upper-limb muscle oxygen saturation during NMES (ON vs OFF)
大体时间：During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
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.
During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.

次要结果测量

结果测量
措施说明
大体时间
Incidence of adverse events and device-related effects
大体时间：During single study visit (approximately 2 hours)
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.
During single study visit (approximately 2 hours)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Kieron.Day

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年9月19日

初级完成 (实际的)

2025年10月3日

研究完成 (实际的)

2025年10月3日

研究注册日期

首次提交

2026年4月10日

首先提交符合 QC 标准的

2026年6月3日

首次发布 (实际的)

2026年6月9日

研究记录更新

最后更新发布 (实际的)

2026年6月9日

上次提交的符合 QC 标准的更新

2026年6月3日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • FFR-ARM-002 (其他赠款/资助编号：Firstkind)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Available upon request

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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