Physiological Responses to Upper Limb NMES
Exploring Local Physiological Changes in the Arm During NMES Using the Firefly® Device
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
Buckinghamshire
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High Wycombe、Buckinghamshire、イギリス、HP11 1JX
- Firstkind
-
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Single experimental arm: Firefly NMES
|
Firefly NMES device applied to the upper limb during a single-visit exploratory pysiological study
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in upper-limb blood flow volume during NMES (ON vs OFF)
時間枠：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.
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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)
時間枠：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)
時間枠：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.
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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)
時間枠：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)
時間枠：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.
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During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of adverse events and device-related effects
時間枠：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.
|
During single study visit (approximately 2 hours)
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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