Quantitation of McArdle's Sign and Evaluation of Specificity for Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Quantitation of McArdle's Sign and Evaluation of Specificity for Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03122873
• Other study ID #: 15-009122
• Status: Completed
• Phase: N/A
• First received: April 6, 2017
• Last updated: August 29, 2017
• Start date: February 1, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is designed to quantitate McArdle's sign, an increase in measurable weakness with neck flexion described in patients with multiple sclerosis, and to determine whether it is or is not specific for multiple sclerosis.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Myelopathy of any cause with finger extension weakness

• Patients with peripheral neuropathy with finger extension weakness

• Healthy controls

Exclusion Criteria:

• Pregnant subjects.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in quantitative measure of strength between extended positions of the neck and fully flexed position of the neck (McArdle's sign)	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.	through study completion, an average of 1 year
Secondary	Relative sensitivity of clinical versus instrument-based detection of McArdle's sign.	Compare the clinical detection of the sign by the referring clinician and technician compared to the device-determined McArdle's sign	through study completion, an average of 1 year