Clinical trial NCT06718855: Cognitive Functioning in People with Myasthenia Graivs: Impact on Daily Life Activities, Work, Disability and Quality of Life
Official title: Cognitive Functioning in People with Myasthenia Graivs: Impact on Daily Life Activities, Work, Disability and Quality of Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myasthenia Gravis
Keywords: Myasthenia Gravis
Cognitive Functioning
Disability
Activities of Daily Living
Quality of Life
Anxiety
Comorbidities
Work
Depression
Memory
Attention
Executive Functions
Cognitive Reserve
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Italian speakers, already followed at Besta Institute

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.

Eligibility criteria: 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)

Primary outcomes:
measure: GEMS
timeFrame: 22 months
Secondary outcomes:
measure: CRIq
timeFrame: 22 months
measure: ENB-3
timeFrame: 22 months
measure: MG-DIS
timeFrame: 22 months
measure: MG-QOL15
timeFrame: 22 months
measure: MG-ADL
timeFrame: 22 months
measure: WPAI-GH
timeFrame: 22 months
measure: HADS
timeFrame: 22 months
measure: FSS
timeFrame: 22 months
measure: CCI
timeFrame: 22 months
measure: Clinical profile
timeFrame: 22 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta
Study officials:
References: