To set up a control group with the aim to obtain reference values that allow for comparisons with data of patients with movement disorders.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences between patients with movement disorders and controls with respect
to autonomic dysfunction, physical features, personality traits, depression,
traumatic experiences and recent life events. Additionally, genetic differences
between both groups.
Secondary outcome
None
Background summary
The department of neurology follows several cohorts of patients with movement
disorders, that is, patients with Parkinson*s disease, tonic dystonia and
complex regional pain syndrome related dystonia, for which a proper control
group currently is not available. The present proposal describes the set-up of
a cohort of control subjects in whom data will be collected that will be
compared to those of patients. Reference values obtained from controls are
important to determine if findings in patients fall in the range of normal
values; differences in comparison to controls may provide hints for potential
causal mechanisms or signal significant co-morbidities. Two-hundred subjects
will be invited to complete questionnaires (either online or on paper)
evaluating constructs that are relevant for comparison with one or more of the
aforementioned patient groups and include depression, autonomic dysfunction,
somatoform dissociation, early traumatic experiences, recent life events,
personality traits and REM sleep behavioural disorder. Data will be entered in
a ProMISe© database and maintained by the department of Medical Statistics of
the LUMC. This database will contain indirectly identifiable subject data only.
Additionally, 20 cc of blood will be collected in 1200 subjects for DNA
isolation. This is necessary to examine if genetic differences exist between
patients and controls; such differences could provide indications for
potentially involved biological pathways and hopefully ultimately lead to more
effective treatments for patients with these conditions. Subjects are also
asked if they give consent to be approached for other future research purposes.
Study objective
To set up a control group with the aim to obtain reference values that allow
for comparisons with data of patients with movement disorders.
Study design
The present proposal involves the set up of a control cohort that allows for
case-control comparisons.
Study burden and risks
The completion of the questionnaires will take approximately one hour. Further,
2 tubes of blood (20 cc) will be drawn. There are no risks or benefits
involved.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
Male and female subjects aged 18 years or older who give informed consent to store their data and have their blood drawn.
Exclusion criteria
Diseases of the central nervous system; anxiety; depression; conditions associated with pain and/or limited function of the neck, back or extremities.
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 | NL29235.058.09 |