The primary objective of this study is to analyze the frequency and severity of fatigue in patients with spinocerebellar ataxia and to test whether duration of the disease, depression and the severity of ataxia are related to the severity of fatigue…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are: difference in FSS-score in our study population
compared to (published) FSS scores in healthy controls and furthermore the
correlation of FSS score and disease duration, severity of ataxia (quantified
with the SARA: scale for assessment and rating of ataxia) and depression
(quantified in the Beck depression inventory). ,
Secondary outcome
Secondary study parameters are: independent correlates of fatigue, studying the
association of frequency and severity of fatigue, measured by FSS, and quality
of life, motor function, disorders of sleep and cognitive functioning, assessed
by the SF-36, the Rotterdam handicap scale, the Pittsburg sleep quality index,
the Epworth sleepiness scale(ESS) and the mini mental state examination (MMSE)
Background summary
Autosomal dominant spinocerebellar ataxia (ADCA) and idiopathic late onset
cerebellar ataxie (ILOCA) are relatively rare neuroodegenerative disorders.
Apart from neurological symptoms, patients indicate fatigue as a severe and
disabling problem. Studies adressing fatigue in other neurodegenerative
disorders like Parkinson's disease (PD)and en multiple sclerosis (MS) and also
in neuromuscular disorders, indicate a high incidence of severe fatigue in
these disorders compared to healthy controls. In both PD and MS, fatigue does
not correlate with severity of motor dysfunction, it is hypothesized that
fatigue is an independent symptom of neurodegeneration. Associations of fatique
with depression, cognitive decline and sleeping disorders have been studied but
there are no unequivocal conclusions.
In a pilot study, we have assessed the fatigue severity scale (FSS) and the
international ataxia rating scale (ICARS) in 20 patients with SCA. The mean FSS
was 5,5. indicating severe fatigue and this score is significantly higher than
in healthy controls. Presence of fatigue did not seem to correlate with
severity of ataxia, measured by the ICARS, however, FSS scores tended to rise
with duration of disease.
Study objective
The primary objective of this study is to analyze the frequency and severity of
fatigue in patients with spinocerebellar ataxia and to test whether duration of
the disease, depression and the severity of ataxia are related to the severity
of fatigue in these patients. These relationships will be adjusted for age and
sex. The secondary objective is to identify the association between the
frequency and severity of fatigue on the one hand and motor dysfunction,
cognitive dysfunction, sleeping disorders and also specific SCA diagnosis on
the other hand.
Study design
observational cross-sectional study
Study burden and risks
All participants will be asked to fill in six self-assessment scales, that will
take aproximately 45 minutes of their time. We will ask 94 patients to visit
the clinic for additional neurological examination and assessment of the mini
mental state examination. This will take another 45 minutes time, plus
travelling time. There are no risks for patients in participating this study
's Gravendijkwal 230
3015 CE Rotterdam
Nederland
's Gravendijkwal 230
3015 CE Rotterdam
Nederland
Listed location countries
Age
Inclusion criteria
diagnosis of autosomal dominant spinocerebellar ataxia (ADCA) or idiopatic late onset cerebellar ataxia (ILOCA), age of 18 years and beyond, able to interpretate self-assessment scales, signed informed consent
Exclusion criteria
ataxia of unknown origin or other diagnosis
age below 18 years
severe psychiatric or cognitive deterioration or other conditions that prevent patients from adequate interpretation of self assessment scales
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25401.078.08 |