The NeuroFab Study: Two year follow-up of Cognitive and Psychological functioning in patients with Fabry Disease.

The NeuroFab Study: Two year follow-up of Cognitive and Psychological functioning in patients with Fabry Disease. - The NeuroFab Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43300

Enrollment

Registered

2016-04-26

Start date

2016-07-14

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alpha-galactosidase A deficiency Anderson-Fabry disease Fabry Disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Fabry patients: * Signed informed consent * Agreeing to be informed about medically relevant personal test-results by a physician * Definite diagnosis of FD according to previously developed diagnostic criteria (see protocol: appendix A, Table 1. for diagnostic criteria).

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria will be excluded from participation in this study: Fabry patients: * Unwillingness to participate * Uncertain FD diagnosis (not fulfilling the criteria mentioned in protocol: appendix A, Table 1) * Unable to execute approximately two hours of neuropsychological tests * Medical conditions which make participation in the study not feasible (e.g. other diseases than FD affecting the brain), decided by a medical doctor during screening * Clinically relevant comorbidities, not attributable to FD, presumably influencing neuropsychological test results * Severe hearing loss and/or vision loss resulting in inability to complete neuropsychological tests and questionnaires

Design outcomes

Primary

Measure	Time frame
Primary objective: * Cognitive functioning and prevalence of cognitive and psychological impairment in Fabry patients assessed with a neuropsychological test battery	—

Secondary

Measure	Time frame
Secondary objectives: * Changes in cognitive and psychological functioning and prevalence of cognitive impairment in Fabry patients assessed with a neuropsychological test battery during two years follow-up * Prevalence of depression assessed with The Center for Epidemiologic Studies Depression Scale Revised * Sleep quality and sleep habits assessed with the Pittsburgh Sleep Quality Index * Physical activity assessed with the International Physical Activity Questionnaire last seven days * Coping strategies assessed with the Utrecht Coping List	—

Measure

Time frame

Secondary objectives: * Changes in cognitive and psychological functioning and prevalence of cognitive impairment in Fabry patients assessed with a neuropsychological test battery during two years follow-up * Prevalence of depression assessed with The Center for Epidemiologic Studies Depression Scale Revised * Sleep quality and sleep habits assessed with the Pittsburgh Sleep Quality Index * Physical activity assessed with the International Physical Activity Questionnaire *last seven days* * Coping strategies assessed with the Utrecht Coping List

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Countries

Netherlands

Outcome results