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

NCT ID: NCT03122873

Last Updated: 2017-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-01

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Peripheral neuropathy

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

No interventions assigned to this group

Healthy Controls

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant subjects.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Brian G. Weinshenker, M.D.

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian Weinshenker, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31303427 (View on PubMed)

Other Identifiers

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15-009122

Identifier Type: -

Identifier Source: org_study_id

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