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Enrolling by Invitation

NCT Number: NCT06877403

Prevalence and Impact of Fatigue in Myasthenic Patients Followed At Clermont-Ferrand University Hospital - "My" Asthenia

After identifying myasthenic patients meeting the inclusion criteria, telephone contact with patients to suggest that they participate in the study by responding to various questionnaires composed of validated scales used in current practice (MG-ADL, MG-QoL-15, MFIS, FSS, PASS, HADS, Godin-Leisure Exercise Time) which will be completed either digitally (REDCap link) or by paper form if necessary. Consultation of patients' medical records to collect information relating to factors associated with fatigue or intrinsic illness (demographic data, comorbidities, progression of the illness, treatments, etc.).

As part of their usual care, myasthenia patients answer questionnaires according to the following procedure :

1. Mailing of questionnaires to all eligible patients before their consultation The questionnaires are composed of scales validated and used in current practice (MG-ADL, MG-QoL-15, MFIS, FSS, PASS, HADS, Godin-Leisure Exercise Time). 2. Collection of questionnaires When patients come for consultation, the completed questionnaires are collected by the medical team. 3. Collection of questionnaires The responses to the questionnaires and the scores and results obtained from these questionnaires are integrated into the patients' medical records.

As part of our study and in parallel with the patient's clinical follow-up, data relating to factors associated with fatigue or intrinsic illness (demographic data, comorbidities, progression of the disease, treatments, etc.) as well as responses to questionnaires will be collected.

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Key information

Conditions

Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Fatigue Immune System Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients who consulted the neurology department of the Clermont-Ferrand University Hospital between 01/01/2022 and 12/31/2024 in the context of their myasthenia and identified by the BAMARA and PMSI databases of the Clermont-Ferrand University Hospital
  • Diagnosis of autoimmune myasthenia gravis based on biological and/or electromyographic criteria
  • MGFA class from I to IV

Exclusion criteria

  • Patients under guardianship or curatorship
  • Non-French speaking patients
  • Patients refusing to participate in the study

Treatment and study plan

Primary outcomes

  1. Prevalence of fatigue

    Time frame: through study completion, an average of 6 month

    Determine the prevalence of fatigue in myasthenic patients followed at the Clermont-Ferrand University Hospital by the Fatigue Severity Scale from 1 to 7. 1 = not significative fatigue. 7 = extreme fatigue. Significant if FSS > 4.

Secondary outcomes

  1. Impact of the fatigue

    Time frame: through study completion, an average of 6 month

    Describe the impact of fatigue on daily life by the Modified Fatigue Impact Scale from 21 to 84. 21 = not significative impact of fatigue on daily life, 84 = severe impact of the fatigue. Significant if MFIS > 45.

Other outcomes

  1. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Disease severity by MG-ADL (from 0 to 24), 0 means no symptom, 24 means severe symptoms. No specific threshold.

  2. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Impact of the disease on the daily-life activities by the MG-QoL-15 (from 0 to 60), 0 means no repercussion, 60 means massive repercussion. No specific threshold.

  3. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Level of anxiety and depression by HADS (< 7 : no symptoms, 8 -11 doubt, > 11 symptoms of anxiety and depression)

  4. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. level of physical activity by Godin Leisure Time Activity Questionnaire (> 24 : active, 14-23 moderate activity, < 14 sedentary)

  5. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Global feeling about the myasthenia by a simple question with the PASS (yes / no)

  6. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Analysis of the medical record for demographic : age in years.

  7. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Analysis of the medical record for demographic : weight in kilograms, height in meters, BMI in kg/m2

  8. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Analysis of the medical record for demographic : duration of the disease in years

  9. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Analysis of the medical record for demographic : type of actual or passed treatment : corticoids, anticholinesterasic, immunosuppressive (Azathioprine, Mycophenolate mofetil, Ciclosporine, Rituximab), novel therapy (Efgartigimod-alpha, Zilucoplan, Ravulizumab). Yes or No for each treatment.

  10. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Analysis of the medical record for demographic : dosage of actual or passed treatment (corticoids, anticholinesterasic, immunosuppressive (Azathioprine, Mycophenolate mofetil, Ciclosporine, Rituximab), novel therapy (Efgartigimod-alpha, Zilucoplan, Ravulizumab). Dosage in mg per day

  11. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Analysis of the medical record for demographic and notably comorbidities : auto-immune (dysthyroiditis, diabete, lupus, rheumatoid arthritis, other). Yes or No.

  12. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Analysis of the medical record for demographic and notably comorbidities : thymectomy. Yes or No.

  13. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Analysis of the medical record for demographic and notably comorbidities : date of the last myasthenic crisis. Month and years or the year exclusively.

  14. Associated factors with fatigue

    Time frame: through study completion, an average of 6 month

    Study the factors associated with fatigue. Analysis of the medical record for demographic and notably comorbidities : date of the last use of crisis treatment (Immunoglobulin, Plasmatic Exchange). Date in month and years or the year exclusively.

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Prospective Study on the Prevalence and Impact of Fatigue in Myasthenic Patients Followed At Clermont-Ferrand University Hospital - "My" Asthenia

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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