- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Stockholm, Suecia
- Department of Hand Surgery, Södersjukhuset Hospital, Stockholm, Sweden
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Viabilidad del dispositivo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Reliability of method: Sensory neurography measurements (AREA) performed on two separate occasions.
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Assessment of agreement AREA
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Cecilia Mellstrand Navarrro, Associate professor, Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2024-08365-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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