Evaluation and comparison of Autonomic Nervous System function with neurophysiological interventions such as pupillometry and Mangina Test in patients with Myasthenia Gravis and healthy subjects

Not Applicable

Completed

• Conditions: patients with Myasthenia Gravis; Neurological - Other neurological disorders; Musculoskeletal - Other muscular and skeletal disorders; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12614000319673
• Lead Sponsor: Antonia Kaltsatou

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

All patients were diagnosed with MG (mean time from the diagnosis was until the beginning of the study 2.9+/-0.2 years) using the established and diagnosis criteria. Specifically, their diagnosis was based on one hand on the clinical symptoms (fatigue during the day, etc), and on the other hand, on the laboratory findings (presence of positive antibodies for the AchR, positive response at the repeated stimuli test). Apart from these, MG patients showed an improvement of the muscle strength following the intake of edrophonium chloride and reacted positively to Mestinon. It was a key inclusion criterion that participants previously showed an improvement of the muscle strength following the intake of edrophonium chloride and reacted positively to Mestinon because from this we were sure that the Myasthenia Gravis Diagnosis was correct.
All patients were free of any other neurological, ophthalmological, physical or mental disease and their visual acuity, corrected or not, were 20/20. Moreover, they had symmetrical pupils and no past history of ocular operations or diseases affecting the pupil and were not being treated at that time with anticholinergics, steroids, sympathomimetics, beta-blockers or other agents affecting the Pupil Light Reflex (PLR). Also, the basic precondition for participation was a mini mental score greater than or equal to 22. All measurements were performed between 09.00 and 10.00 hours after the participants had had a full eight-hour sleep.

Exclusion Criteria

If MG patients do not show an improvement of the muscle strength following the intake of edrophonium chloride and reacted positively to Mestinon.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Two pupillometric indices Maximum Velocity of Constriction (VCmax) and Maximum Acceleration of Constriction (ACmax) are governed mainly by the action of the Parasympathetic Nervous System, through Acetylcholine. The Myasthenic patients showed decreased VCmax and ACmax compared to healthy controls and significant decreased scores in the Mangina-Test as compared to healthy controls. Accordingly, the results of this study demonstrate that the Central Nervous System is affected and that MG has central cholinergic effects manifested by cognitive dysfunction.[Assessed at time of pupillometric measurements and the original psychophysical paper-and-pencil version of the Mangina-Test were performed on the participants.]

Secondary Outcome Measures

Name	Time	Method
From the pupillometric results we assumed that the iris sphincter smooth muscle is affected in Myasthenia Gravis patients[Assessed at time of pupillometric measurements and the original psychophysical paper-and-pencil version of the Mangina-Test were performed on the participants]