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Clinical Trials in Poland / NCT05337891
Recruiting Observational

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

NCT05337891 · tracked via the Priya Life Science Poland tracker
Sponsor
Jagiellonian University
Phase
Observational
Started
2022-06-03
Last updated
2024-10-10

Condition(s) studied

Myasthenia Gravis

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Difference in the highest decrement between investigation of nasalis during morning and evening RNS — Through study completion, an average of 1 year.
    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.
  • Difference in the highest decrement between investigation of trapezius during morning and evening RNS — Through study completion, an average of 1 year.
    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.
  • Difference in the highest decrement between investigation of nasalis during morning RNS with single and with two voluntary efforts — Through study completion, an average of 1 year.
    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.
  • Difference in the highest decrement between investigation of trapezius during morning RNS with single and with two voluntary efforts — Through study completion, an average of 1 year.
    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.

Trial sites (1)

FacilityCityRegionStatus
Jagiellonian University Medical College, Department of Neurology Krakow Lesser Poland Voivodeship Recruiting

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Other trials for the same condition

A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis Recruiting
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis Recruiting
A Phase 3 Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Patients With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis Active, not recruiting
Myasthenia Gravis Inebilizumab Trial Active, not recruiting
ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05337891 on ClinicalTrials.gov ↗ ← All trials in Poland