Myasthenia Gravis
Conditions
Keywords
Myasthenia Gravis, Cognitive Functioning, Disability, Activities of Daily Living, Quality of Life, Anxiety, Comorbidities, Work, Depression, Memory, Attention, Executive Functions, Cognitive Reserve
Brief summary
MYCOG primarily aims to estimate the prevalence of cognitive difficulties in patients with MG treated at Besta Institute. Secondary aims include: a) assess the degree to which cognitive difficulties are associated to work impairment, limitations in ADL, symptoms of anxiety and depression, fatigue, disability and QoL; b) assess whether patients with different MG types show different degrees of cognitive impairment; c) assess whether patients with different MG antibody profiles show different degrees of cognitive impairment; d) assess whether patients under different MG-specific pharmacological treatments show different degrees of cognitive impairment.
Detailed description
Previous literature findings provide contradictory indications about presence of cognitive impairment in patients with MG, but patients experience different degree of limitations in ADLs, disability and QoL which might not be entirely understood on the basis of neuromuscular symptoms. We therefore aimed to address the potential impact of cognitive impairment. MYCOG is a monocentric, cross-sectional and observational study which primarily aims to estimate the prevalence of cognitive difficulties, measured with Global Examination of Mental State (GEMS), in patients with MG treated at Besta Institute. Secondary aims include: a) assess the degree to which cognitive difficulties are associated to work impairment (measured with WPAI-GH), limitations in ADL (measured with MG-ADL), symptoms of anxiety and depression (measured with HADS), fatigue (measured with FSS), disability and QoL (measured with MG-DIS and MG-QOL15); b) assess whether patients with different MG types (ocular, generalized, bulbar, pharmacological remission and clinical stable remission) show different degrees of cognitive impairment; c) assess whether patients with different MG antibody profiles (AChR, MuSK, Double Negative) show different degrees of cognitive impairment; d) assess whether patients under different MG-specific pharmacological treatments (piridogstigmine, steroids, other therapies such as immunemodulators) show different degrees of cognitive impairment.
Interventions
None listed
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with MG, * followed-up at Besta institute * aged 18-99, * able to understand Italian language;
Exclusion criteria
* psychiatric comorbidies of psychotic nature; * do not accept to participate on a voluntary basis; * patients who should be excluded based on physician's judgement; * patients who live in a nursing home for aged or disabled persons; * respiratory impairment (patients under mechanical ventilation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GEMS | 22 months | Global examination of cognitive functioning |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CRIq | 22 months | Cognitive reserve index |
| ENB-3 | 22 months | Brief Neuropsychological battery |
| MG-DIS | 22 months | Disability |
| MG-QOL15 | 22 months | Quality of life |
| MG-ADL | 22 months | Activities of Daily Living |
| WPAI-GH | 22 months | Impact on work-related activities and productivity |
| HADS | 22 months | Anxiety and depression |
| FSS | 22 months | Fatigue Severity |
| CCI | 22 months | Presence of comorbidities |
| Clinical profile | 22 months | General information on MG type, antibody profile, sociodemographic information, MG-specific symptoms, pharmacological therapy |
Countries
Italy
Outcome results
None listed