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NCT05337891

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

StatusUnknown
PhaseNot specified
Primary completion (estimated)
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Record History

All 5 versions: 4 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Oct 2024); last known: Recruiting
  2. Primary completion date: May 1, 2024 to May 1, 2026
    • Study completion date: Sep 1, 2024 to Sep 1, 2026
    v5
  3. Start date changed from estimate of May 1, 2022 to Jun 3, 2022v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Eligibility criteria shortened, about 4 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Study description shortened, about 12 words
    • Site details revised
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Difference in the highest decrement between investigation of nasalis during morning and evening RNS
Timeframe: Through study completion, an average of 1 year.
Difference in the highest decrement between investigation of trapezius during morning and evening RNS
Timeframe: 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
Timeframe: 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
Timeframe: Through study completion, an average of 1 year.

Secondary (5)

Difference in the percentage of abnormal RNS results between RNS performed in the morning and in the evening
Difference in the percentage of abnormal RNS results between RNS performed in the morning with single and with two voluntary efforts
Correlation between the highest decrement during morning RNS with single one-minute voluntary effort and the MG-ADL score
Correlation between the highest decrement during RNS with two one-minute voluntary efforts and the MG-ADL score
Correlation between the highest decrement during evening RNS and the MG-ADL score

Arms and interventions

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

Sites

1 site in 1 country

  • Jagiellonian University Medical College, Department of NeurologyKrakow, Lesser Poland Voivodeship, Poland