Myasthenia Gravis (MG), Myasthenic Crisis
Conditions
Keywords
Myasthenia Gravis, Myasthenic Crisis, Intravenous Immunoglobulin (IVIG), Plasma Exchange (PLEX), Quantitative Myasthenia Gravis Score (MGQS), Syria
Brief summary
This study compares the clinical effectiveness of Intravenous Immunoglobulin (IVIG) versus Plasma Exchange (PLEX) in patients experiencing a myasthenic crisis. Clinical response is evaluated 14 days post-treatment using the Quantitative Myasthenia Gravis Score (QMG). Additionally, the study aims to identify and report common precipitating factors for myasthenic attacks, such as respiratory infections or surgical stress.
Detailed description
This open-label prospective study evaluates patients at Al-Mouwasat and Al-Assad University Hospitals in Damascus, Syria. Participants include adult patients diagnosed with Myasthenia Gravis (MG) based on clinical evaluation and confirmed via repetitive nerve stimulation (RNS) or single-fiber electromyography (SFEMG). Participants are assigned to two treatment groups based on the availability of medical supplies at the time of admission: the IVIG group and the PLEX group. The IVIG group receives a total dosage of 2 g/kg administered over 2 to 5 consecutive days. The PLEX group undergoes a series of up to five plasma exchange sessions. The primary objective is to evaluate the change in the Quantitative Myasthenia Gravis Score (QMG) from baseline (Day 0) to 14 days post-treatment. The study also documents precipitating triggers for myasthenic attacks. Statistical analysis is performed using SPSS version 25.0, utilizing T-tests for continuous variables and Chi-Squared tests for categorical variables to compare the treatment methods.
Interventions
BIOLOGICALIVIG (Intravenous Immunoglobulin)
Patients receive Intravenous Immunoglobulin (IVIG) at a total dose of 2 g/kg body weight. The dose is divided over a period of 2 to 5 consecutive days administered intravenously
PROCEDUREPlasma exchange (PE)
Patients undergo therapeutic plasma exchange (PLEX), typically consisting of 5 sessions performed every other day., with a replacement volume of 1 to 1.5 plasma volumes per session.
Sponsors
Damascus University
Al Mouwasat Hospital
Al-Assad University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
None (open Lable)
Intervention model description
A prospective, non-randomized, parallel-group study comparing the efficacy of IVIG versus Plasma Exchange in patients with Myasthenic Crisis.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed Diagnosis: Patients with newly diagnosed or previously confirmed Myasthenia Gravis (MG) based on clinical evaluation and confirmed by electromyography (EMG). * Severity: Patients presenting with myasthenic crisis or severe exacerbation. * Age: 18 years and older. * Treatment Necessity: Patients requiring rapid immunomodulating therapy (either IVIG or PLEX). * Informed Consent: Participants or their legal guardians must be able and willing to provide written informed consent.
Exclusion criteria
* Medical Contraindications: Severe renal failure (contraindication for IVIG) or hemodynamic instability (contraindication for PLEX). * Alternative Conditions: Presence of other neuromuscular disorders or congenital myasthenia. * Pregnancy: Pregnant or breastfeeding women. * Consent: Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change from Baseline in the Quantitative Myasthenia Gravis (QMG) Score | Day 14 post-initiation of treatment | The QMG is a validated physician-rated instrument consisting of 13 items that assess ocular, bulbar, respiratory, and limb muscle strength. Total scores range from 0 to 39, where higher scores represent greater clinical impairment. Clinical improvement is defined as a reduction in the mean QMG score from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Anti-AChR Antibodies. | Day 14 post-treatment | Evaluation of the frequency of positive anti-acetylcholine receptor (AChR) antibodies among the study population to assess its correlation with the severity of the myasthenic crisis. |
| Frequency of Myasthenic Crisis Triggers | Through hospital discharge, average 14 days | Identification and categorization of the most common factors leading to myasthenic crisis, such as respiratory infections or surgical stress. |
Countries
Syria
Contacts
PRINCIPAL_INVESTIGATORMohammad Shehadeh Agha, MD, PhD
Damascus University
Outcome results
None listed