Physiological Responses to Upper Limb NMES
3 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
10
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Buckinghamshire
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High Wycombe, Buckinghamshire, Verenigd Koninkrijk, HP11 1JX
- Firstkind
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Single experimental arm: Firefly NMES
|
Firefly NMES device applied to the upper limb during a single-visit exploratory pysiological study
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in upper-limb blood flow volume during NMES (ON vs OFF)
Tijdsspanne: 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
|
|
Change in upper-limb peak systolic velocity during NMES (ON vs OFF)
Tijdsspanne: 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.
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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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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.
|
During a single study visit (approximately 2 hours), across repeated stimulation ON/OFF cycles.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence of adverse events and device-related effects
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
19 september 2025
Primaire voltooiing (Werkelijk)
3 oktober 2025
Studie voltooiing (Werkelijk)
3 oktober 2025
Studieregistratiedata
Eerst ingediend
10 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
3 juni 2026
Eerst geplaatst (Werkelijk)
9 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
3 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- FFR-ARM-002 (Ander subsidie-/financieringsnummer: Firstkind)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Available upon request
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- ICF
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .