Multiple SclerosisNCT03122873
Quantitation of McArdle's Sign and Evaluation of Specificity for Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2016to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with myelopathy of any cause and peripheral neuropathy who have detectable finger extension weakness.
Who may be able to join
- Myelopathy of any cause with finger extension weakness
- Patients with peripheral neuropathy with finger extension weakness
- Healthy controls
Who cannot join
- Pregnant subjects.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Feb 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian G. Weinshenker, M.D., Mayo Clinic
- Investigators
- Brian Weinshenker, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122873
- Sponsor's protocol ID
- 15-009122
- Status last verified
- Aug 2017
- First submitted
- 6 Apr 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31303427
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitation of McArdle's Sign and Evaluation of Specificity for Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03122873
- Acronym / sponsor ID
- 15-009122
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myelopathy of any cause and peripheral neuropathy who have detectable finger extension weakness.
Key inclusion criteria (3 listed)
- Myelopathy of any cause with finger extension weakness
- Patients with peripheral neuropathy with finger extension weakness
- Healthy controls
Key exclusion criteria (1 listed)
- Pregnant subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Relative sensitivity of clinical versus instrument-based detection of McArdle's sign.
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Derived from this study: PubMed 31303427Savoldi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Weinshenker, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03122873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017.