Evaluating the best time for nerve stimulation tests in Myasthenia Gravis
Sensitivity of Repetitive Nerve Stimulation Performed in the Evening vs in the Morning and With Single vs Repeated Effort in Myasthenia Gravis
Jagiellonian University · NCT05337891
This study is testing if doing nerve stimulation tests in the evening gives better results for people with Myasthenia Gravis than doing them in the morning.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Jagiellonian University (other) |
| Locations | 1 site (Krakow, Lesser Poland Voivodeship) |
| Trial ID | NCT05337891 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how the time of day affects the sensitivity of repetitive nerve stimulation (RNS) tests in patients with Myasthenia Gravis (MG). The researchers hypothesize that RNS performed in the evening may yield more accurate results compared to tests conducted in the morning. By measuring the electrical responses of muscles after nerve stimulation, the study seeks to improve diagnostic accuracy for both ocular and generalized forms of MG. The study will include patients with confirmed or suspected MG who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates include patients with suspected or diagnosed Myasthenia Gravis who have a disease severity of at least 1.
Not a fit: Patients with respiratory failure, severe bulbar symptoms, or those on medications that may worsen neuromuscular transmission disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the diagnostic sensitivity of nerve stimulation tests, leading to better management of Myasthenia Gravis.
How similar studies have performed: While the sensitivity of RNS has been previously studied, this specific approach of evaluating the time of day for testing is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Krakow, Lesser Poland Voivodeship
- Jagiellonian University Medical College, Department of Neurology — Krakow, Lesser Poland Voivodeship, Poland (RECRUITING)
Study contacts
- Principal investigator: Jakub M Antczak, MD — Jagiellonian University Medical College, Department of Neurology
- Study coordinator: Jakub M Antczak, MD
- Email: jantczak@cm-uj.krakow.pl
- Phone: +48 795 421 153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myasthenia Gravis, Repetitive Nerve Stimulation, effort, Morning, Evening