Quantitation of McArdle's Sign and Evaluation of Specificity for Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT03122873|
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : August 30, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||125 participants|
|Official Title:||Quantitation of McArdle's Sign and Evaluation of Specificity for Multiple Sclerosis|
|Actual Study Start Date :||February 1, 2016|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2017|
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).
Male or female 18 years or older with C7 radiculopathy, radial neuropathy, plexopathy, peripheral neuropathy, who have detectable finger extension weakness.
Male and female 18 year or older with no finger extension weakness and no known neurological conditions.
- Difference in quantitative measure of strength between extended positions of the neck and fully flexed position of the neck (McArdle's sign) [ Time Frame: through study completion, an average of 1 year ]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.
- Relative sensitivity of clinical versus instrument-based detection of McArdle's sign. [ Time Frame: through study completion, an average of 1 year ]Compare the clinical detection of the sign by the referring clinician and technician compared to the device-determined McArdle's sign
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122873
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Brian Weinshenker, MD||Mayo Clinic|