Sensitivity of Repetitive Nerve Stimulation Performed in the Evening vs in the Morning in Myasthenia Gravis

NCT05337891 | Recruiting

• 1 other identifier: JagiellonianU70
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Myasthenia gravis (MG) is the autoimmune disorder affecting the neuromuscular junction, characterized by fatigue, which increases gradually through the day. The repetitive nerve stimulation (RNS) remains the key diagnostic test in MG, however its sensitivity, especially in ocular form of MG is not satisfactory. In this study, investigators want to assess the impact of the time of the day on the sensitivity of the RNS. We hypothesize the RNS performed in the evening may be more sensitive than in the morning.

Conditions

Myasthenia Gravis

Keywords

Myasthenia Gravis; Repetitive Nerve Stimulation; effort; Morning; Evening

Outcome Measures

Primary Outcomes (4)

• Difference in the highest decrement between investigation of nasalis during morning and evening RNS

  Difference in the highest decrement between investigation of nasalis during morning (at 8:30 or 8:50 a.m.) RNS with single one-minute voluntary effort and RNS at 2:30 p.m.

  Through study completion, an average of 1 year.

• Difference in the highest decrement between investigation of trapezius during morning and evening RNS

  Difference in the highest decrement between investigation of trapezius during morning (at 8:30 or 8:50 a.m.) RNS with single one-minute voluntary effort and RNS at 2:30 p.m.

  Through study completion, an average of 1 year.

• Difference in the highest decrement between investigation of nasalis during morning RNS with single and with two voluntary efforts

  Difference in the highest decrement between investigation of nasalis during morning (at 8:30 or 8:50 a.m.) RNS with single one-minute voluntary effort and RNS with two one-minute voluntary efforts.

  Through study completion, an average of 1 year.

• Difference in the highest decrement between investigation of trapezius during morning RNS with single and with two voluntary efforts

  Difference in the highest decrement between investigation of trapezius during morning (at 8:30 or 8:50 a.m.) RNS with single one-minute voluntary effort and RNS with two one-minute voluntary efforts.

  Through study completion, an average of 1 year.

Secondary Outcomes (5)

• Difference in the percentage of abnormal RNS results between RNS performed in the morning and in the evening

  Through study completion, an average of 1 year.

• Difference in the percentage of abnormal RNS results between RNS performed in the morning with single and with two voluntary efforts

  Through study completion, an average of 1 year.

• Correlation between the highest decrement during morning RNS with single one-minute voluntary effort and the MG-ADL score

  Through study completion, an average of 1 year.

• Correlation between the highest decrement during RNS with two one-minute voluntary efforts and the MG-ADL score

  Through study completion, an average of 1 year.

• Correlation between the highest decrement during evening RNS and the MG-ADL score

  Through study completion, an average of 1 year.

Study Arms (1)

Patients with suspected or diagnosed myasthenia gravis

Patients with suspected or diagnosed myasthenia gravis (ocular and generalized form), aged 18-80, both sexes, with performed or planned determination of anti-acetylcholine receptor antibodies and muscle-specific tyrosine kinase antibodies

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Convenience sample of 40 people with suspected or diagnosed myasthenia gravis (ocular and generalized form). Patients will be recruited from the Outpatient Clinic of the Neurology Clinic of University Hospital in Cracow

You may qualify if:

• Patients with suspected or diagnosed myasthenia gravis (ocular and generalized form)
• Patients with performed or planned determination of anti-AChrR and anti-MUSK antibodies.
• Disease severity of at least 1 in the classification of the severity of myasthenia gravis according to the recommendations of the Myasthenia Gravis Foundation of America

You may not qualify if:

• respiratory failure
• severe bulbar symptoms
• pharmacotherapy with substances that may worsen neuromuscular transmission disorders
• current infection
• coexisting diseases of the peripheral nervous system which may affect the result of the fatigue test, e.g. polyneuropathy or myopathy
• cognitive and behavioral disorders that may negatively affect patient's adherence to study protocol
• Medication with steroids due to myasthenia
• Severity of myasthenia that makes the discontinuation of acetylcholinesterase inhibitors unsafe.

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College, Department of Neurology

Krakow, Lesser Poland Voivodeship, 31503, Poland

RECRUITING

Related Publications (4)

• Witoonpanich R, Dejthevaporn C, Sriphrapradang A, Pulkes T. Electrophysiological and immunological study in myasthenia gravis: diagnostic sensitivity and correlation. Clin Neurophysiol. 2011 Sep;122(9):1873-7. doi: 10.1016/j.clinph.2011.02.026. Epub 2011 Mar 17.

  PMID: 21419697 RESULT

• Bou Ali H, Salort-Campana E, Grapperon AM, Gallard J, Franques J, Sevy A, Delmont E, Verschueren A, Pouget J, Attarian S. New strategy for improving the diagnostic sensitivity of repetitive nerve stimulation in myasthenia gravis. Muscle Nerve. 2017 Apr;55(4):532-538. doi: 10.1002/mus.25374. Epub 2017 Jan 3.

  PMID: 27511866 RESULT

• Wolfe GI, Herbelin L, Nations SP, Foster B, Bryan WW, Barohn RJ. Myasthenia gravis activities of daily living profile. Neurology. 1999 Apr 22;52(7):1487-9. doi: 10.1212/wnl.52.7.1487.

  PMID: 10227640 RESULT

• Jaretzki A 3rd, Barohn RJ, Ernstoff RM, Kaminski HJ, Keesey JC, Penn AS, Sanders DB. Myasthenia gravis: recommendations for clinical research standards. Task Force of the Medical Scientific Advisory Board of the Myasthenia Gravis Foundation of America. Neurology. 2000 Jul 12;55(1):16-23. doi: 10.1212/wnl.55.1.16. No abstract available.

  PMID: 10891897 RESULT

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jakub M Antczak, MD

  Jagiellonian University Medical College, Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakub M Antczak, MD

CONTACT

+48 795 421 153; jantczak@cm-uj.krakow.pl

Study Design

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

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: June 3, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available after the study results will be published.
• Access Criteria: On request sent by e-mail to jakub.antczak@uj.edu.pl

Locations

PL (1)