- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07605585
Sensory Neurography and S2PD, a Test-Retest Study
Sensory Neurography and S2PD: A Test-Retest Study in Ten Healthy Individuals to Assess Method Reliability
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
A neurophysiological examination can objectively measure remaining function in an injured digital nerve. Using this method, axons that are still able to conduct an action potential are assessed.
The response can be measured as the amplitude (the summed action potentials from the nerve's axons) and as the area (the amount of functioning axons). The area is a somewhat more precise measurement method, as it includes all axons, both those with low and high conduction velocities. Amplitude measurements may give falsely low values if nerves with poorer degrees of myelination are included in the measurement. Amplitude is measured in µV (microvolt) and area in µV/ms (microvolt per millisecond).
The method currently used to assess discriminative sensation is the S2PD-test. In this test two pins are pressed perpendicular and longitudinally on each side of the fingertip. The pins can consist of an unfolded paper clip or a factory-made discriminator. The distance between the two pins, where it is possible to discriminate between one or two pins, is the S2PD. The test is influenced by many external factors, such as the clinician's level of experience, the patient's desire to give the correct answer, language barriers, and similar issues. Furthermore, this examination method does not clarify what is actually being measured beyond the patient's subjective discriminative sensation.
If neurophysiological assessment is used as a complement to S2PD and can provide an objective measurement tool with high reliability and reproducibility, it could become an important addition to the clinical arsenal for follow-up after nerve injury. Such knowledge would make it easier to clinically evaluate, understand, and monitor the healing process of the injured nerve. It would also facilitate the assessment and systematic follow-up of treatment outcomes.
The participants will be examined at the Hand Surgery Clinic at South General Hospital at two separate occasions separated. Each visit is estimated to last approximately 60 minutes. It will include assessment using S2PD and neurophysiological examination of the radial side of the second and fourth fingers on both hands.
Finger temperature will be measured using an infrared thermometer (Testo 826-T2), and, if necessary, the fingers will be warmed (using a water bath, heating pad or something similar) to a target temperature of a minimum of 32 °C. The hands will then be gently abraded using a preparation gel (NuPrep). Conductive gel (Ten20) will be applied to the electrodes.
A recording electrode will be placed volarly over the wrist, a ground electrode in the palm, and the stimulating electrode on the radial side of the finger (digits II and IV). Electrical stimulation will be delivered in an orthodromic direction, from the finger toward the wrist. The stimulus intensity will be gradually increased until no further increase in amplitude is observed/amplitude is stable. At the first visit, the examination begins with S2PD followed by sensory neurography. At the second visit, the order of the assessments is reversed to minimize potential crossover effects.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Stockholm, Suède
- Department of Hand Surgery, Södersjukhuset Hospital, Stockholm, Sweden
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age >20
- Age <60
Exclusion Criteria:
- Neurologic disease
- Dementia
- Cognitive disability
- Severe psychiatric disorder (not be able to participate)
- Ongoing drug abuse
- Not understanding swedish language
- History of carpal tunnel syndrome
- Negative experience of electric stimulation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Faisabilité de l'appareil
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: S2PD and sensory neurography
Radial digital nerve of second and fourth finger on both hands, are first examined with S2PD, secondly with Sensory neurography.
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see section "study description"
see section "study description"
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Comparateur actif: Sensory neurography and S2PD
Radial digital nerve of second and fourth finger on both hands, are first examined with Sensory neurography, secondly with S2PD
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see section "study description"
see section "study description"
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Reliability of method: Sensory neurography measurements (AREA) performed on two separate occasions.
Délai: Measures will be assessed at baseline and 2 weeks.
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ICC (Intraclass correlation coefficient) will be used to assess correlation between measurements at baseline and 2 weeks
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Measures will be assessed at baseline and 2 weeks.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Assessment of agreement AREA
Délai: Measurements will be performed at baseline and at 2 weeks.
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The Bland-Altman method will be used to assess whether the measurement method demonstrates sufficient agreement to be considered reliable.
The predefined limit for acceptable differences between measurements is 50%.
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Measurements will be performed at baseline and at 2 weeks.
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Reliability of method: Sensory neurography measurements (SNAP) performed on two separate occasions
Délai: Measures will be assessed at baseline and 2 weeks.
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ICC (Intraclass correlation coefficient) will be used to assess whether the measurement method demonstrates sufficient correlation to be considered reliable.
|
Measures will be assessed at baseline and 2 weeks.
|
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Assessment of agreement SNAP
Délai: Measurements at baseline and 2 weeks
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The Bland-Altman method will be used to assess whether the measurement method demonstrates sufficient agreement to be considered reliable.
The predefined limit for acceptable differences between measurements is 50%.
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Measurements at baseline and 2 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Cecilia Mellstrand Navarrro, Associate professor, Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden
Publications et liens utiles
Publications générales
- Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
- Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 Jun;8(2):135-60. doi: 10.1177/096228029900800204.
- Bland JM, Altman DG. Comparing methods of measurement: why plotting difference against standard method is misleading. Lancet. 1995 Oct 21;346(8982):1085-7. doi: 10.1016/s0140-6736(95)91748-9.
- Pan D, Patel AU, Patterson JM, Johnson AR, Gordon T, Mackinnon SE. Surgeons, physiatrists and neurologists speaking "EDX and nerve surgery": A paradigm shift for nerve injured patients. JPRAS Open. 2025 Nov 12;47:3-20. doi: 10.1016/j.jpra.2025.11.004. eCollection 2025.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2024-08365-02
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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