Quantitation of McArdle's Sign and Evaluation of Specificity for Multiple Sclerosis
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Finger strength will be measure using a torque-measuring device designed to quantitate finger extension strength. The device was designed for point of treatment use, patient safety and portability. Strength will be measured in 5 paired trials, first with neck extended and then with neck flexed. Two protocols will be evaluated, one testing isometric strength against a fixed resistance and the second testing strength against dynamic resistance. McArdle's sign is the difference between strength with neck extension and strength with neck flexion.
The data will be digitally registered and dynamic neck position will be recorded electronically in real time. Graphs of dynamic changes in torque versus neck position will be generated and superimposed. Strength will be quantitated using Matlab software.
Consecutive patients with myelopathy of any cause with detectable finger extensor weakness will be studied, either due to MS or due to other cause of myelopathy (other inflammatory, vascular, compressive, neoplastic and other). Additionally, normal controls will be studied as will patients with finger extension weakness due to peripheral nerve lesions.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Myelopathy of any cause with finger extension weakness
- Patients with peripheral neuropathy with finger extension weakness
- Healthy controls
Exclusion Criteria:
- Pregnant subjects.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Myelopathy of any cause
Male or female 18 years or older with myelopathy and detectable finger extension weakness due to 1) prototypic multiple sclerosis (N=50) 2) other etiologies of myelopathy (N=50), including other inflammatory conditions (e.g.
idiopathic transverse myelitis, neuromyelitis optica, acute disseminated encephalomyelitis, sarcoidosis) or other etiologies (compression, vascular disorders, degenerative disorders, neoplasms).
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Peripheral neuropathy
Male or female 18 years or older with C7 radiculopathy, radial neuropathy, plexopathy, peripheral neuropathy, who have detectable finger extension weakness.
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Healthy Controls
Male and female 18 year or older with no finger extension weakness and no known neurological conditions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Difference in quantitative measure of strength between extended positions of the neck and fully flexed position of the neck (McArdle's sign)
Periodo de tiempo: through study completion, an average of 1 year
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Comparison of means and medians of the difference in strength in the fully extended and fully flexed positions ("McArdle's sign") measured using a torque measurement device between multiple sclerosis versus other myelopathy and between multiple sclerosis and normal controls; measurements are done in 5 successive trials of extension and flexion and the mean percentage difference between extension and flexion of the last 4 trials is averaged to calculated the McArdle's sign; the goal is to determine whether there is a specific level of McArdle sign that is diagnostic for MS using receiver operator curve method.
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through study completion, an average of 1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Relative sensitivity of clinical versus instrument-based detection of McArdle's sign.
Periodo de tiempo: through study completion, an average of 1 year
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Compare the clinical detection of the sign by the referring clinician and technician compared to the device-determined McArdle's sign
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through study completion, an average of 1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Brian Weinshenker, MD, Mayo Clinic
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15-009122
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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