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

NCT03122873 | Completed

• 1 other identifier: 15-009122
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relative sensitivity of clinical versus instrument-based detection of McArdle's sign.

  through study completion, an average of 1 year

Study Arms (3)

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).

Peripheral neuropathy

Male or female 18 years or older with C7 radiculopathy, radial neuropathy, plexopathy, peripheral neuropathy, who have detectable finger extension weakness.

Healthy Controls

Male and female 18 year or older with no finger extension weakness and no known neurological conditions.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with myelopathy of any cause and peripheral neuropathy who have detectable finger extension weakness.

You may qualify if:

• Myelopathy of any cause with finger extension weakness
• Patients with peripheral neuropathy with finger extension weakness
• Healthy controls

You may not qualify if:

• Pregnant subjects.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Savoldi F, Nasr Z, Hu W, Schilaty ND, Delgado AM, Mandrekar J, Kaufman KR, Berglund L, Weinshenker BG. McArdle Sign: A Specific Sign of Multiple Sclerosis. Mayo Clin Proc. 2019 Aug;94(8):1427-1435. doi: 10.1016/j.mayocp.2019.01.047. Epub 2019 Jul 11.

  PMID: 31303427 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Brian Weinshenker, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 21, 2017
• Study Start: February 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: August 30, 2017

Record last verified: 2017-08

Locations

US (1)