Quantitation of McArdle's Sign and Evaluation of Specificity for Multiple Sclerosis
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Minnesota
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Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Relative sensitivity of clinical versus instrument-based detection of McArdle's sign.
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Brian Weinshenker, MD, Mayo Clinic
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 15-009122
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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