Physiological Responses to Upper Limb NMES
3 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
10
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Buckinghamshire
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High Wycombe, Buckinghamshire, Royaume-Uni, HP11 1JX
- Firstkind
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Single experimental arm: Firefly NMES
|
Firefly NMES device applied to the upper limb during a single-visit exploratory pysiological study
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in upper-limb blood flow volume during NMES (ON vs OFF)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of adverse events and device-related effects
Délai: 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.
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During single study visit (approximately 2 hours)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
19 septembre 2025
Achèvement primaire (Réel)
3 octobre 2025
Achèvement de l'étude (Réel)
3 octobre 2025
Dates d'inscription aux études
Première soumission
10 avril 2026
Première soumission répondant aux critères de contrôle qualité
3 juin 2026
Première publication (Réel)
9 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- FFR-ARM-002 (Autre subvention/numéro de financement: Firstkind)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Available upon request
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .