- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Stockholm, Szwecja
- Department of Hand Surgery, Södersjukhuset Hospital, Stockholm, Sweden
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Wykonalność urządzenia
- Przydział: Nielosowe
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Aktywny komparator: 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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Aktywny komparator: 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"
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Reliability of method: Sensory neurography measurements (AREA) performed on two separate occasions.
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Assessment of agreement AREA
Ramy czasowe: 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
Ramy czasowe: Measures will be assessed at baseline and 2 weeks.
|
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.
|
|
Assessment of agreement SNAP
Ramy czasowe: Measurements at baseline and 2 weeks
|
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%.
|
Measurements at baseline and 2 weeks
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Cecilia Mellstrand Navarrro, Associate professor, Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 2024-08365-02
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- ANALITYCZNY_KOD
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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