The main objective of this study is to investigate the role of environmental factors in general, and pesticides in particular, in the aetiology of PD.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in lifetime exposure to pesticides
between cases and controls. Lifetime exposure will be estimated using
complementary modalities that focus on occupational, residential, and household
exposure. Exposure will be assessed using three complementary modalities:
questionnaires, existing databases (medication records, the residential history
from the *personal records database*, and pesticide use database), and
measurements (blood, saliva, faeces, ultrasound measurements of bone, and via
silicone wristbands). Furthermore, the study design allows assessment of other
external factors that may be associated with the risk of PD. We will
specifically quantify exposure to the following three groups of other external
factors: heavy metals, solvents, and air pollution. If other potential risk
factors of PD emerge during the study, we intend to also assess exposure to
those factors by leveraging materials that have already been collected at
baseline (if applicable) in order to answer future questions. Additionally,
clinical progression of cases will be serially assessed for 36 months using an
annual follow-up questionnaire. In the Nijmegen region, we will expand annual
follow-up by using silicone wristbands and wrist-based sensors to assess
exposure and clinical progression, respectively.
Secondary outcome
See above.
Background summary
Parkinson*s disease (PD) is the fastest growing neurological disease in the
world. Recent evidence suggests that a part of the PD disease burden can be
explained by exposure to environmental factors such as pesticides. However,
insight on the extent of their role in the aetiology of PD remains scarce.
Study objective
The main objective of this study is to investigate the role of environmental
factors in general, and pesticides in particular, in the aetiology of PD.
Study design
In this hospital-based case-control study, the exposure to pesticides and other
environmental factors will be mapped in a representative sample of persons with
newly diagnosed PD and age- and sex-matched controls in the Netherlands.
Study burden and risks
After informed consent, data collection for this study will consist of
questionnaires (baseline and follow-up) and biological material. We will also
access existing databases. Study participation includes one study visit at
baseline, during which blood and saliva are collected and bone metal is
measured (Nijmegen region only). All other assessments can be performed
remotely, including self-collection of faeces. The estimated duration of the
assessments are 100 minutes for the questionnaire at baseline for cases and 45
minutes for controls, 25 minutes for measurements during the study visit, 10
minutes for self-collection of faeces (cases only), and 55 minutes for the
follow-up questionnaire (cases only). Wristbands are worn for two weeks and
wrist-based sensors (only cases in Nijmegen region) for one week. Overall, we
believe that burden and risks associated with participation are limited. Both
cases and controls may withdraw from the study at any time.
Reinier Postlaan 4
Nijmegen 6525GC
NL
Reinier Postlaan 4
Nijmegen 6525GC
NL
Listed location countries
Age
Inclusion criteria
Cases:
- Incident Parkinson*s disease;
o Defined as <=1 month since diagnosis was made by a neurologist in the
Netherlands at the moment of recruitment.
- Aged >=18 years;
- Willing and able to provide informed written or digital consent.
Controls:
- Diagnosed with one of the following specific set of diseases:
o A median nerve neuropathy due to entrapment in the carpal tunnel (carpal
tunnel syndrome), ulnar nerve neuropathy or compressive peroneal nerve
neuropathy which is not related to a trauma or autoimmune disease;
* Confirmed by a clinical diagnosis combined with electromyography and/or
ultrasound.
o Disc herniation (hernia);
o Sciatica;
o Lumbago;
o Radiculopathy.
- Aged >=18 years;
- Willing and able to provide informed written or digital consent.
Exclusion criteria
Cases:
- Initially diagnosed in a non-participating centre and referred to one of the
participating hospitals for follow-up care or a second opinion.
- Other neurodegenerative diseases (e.g. atypical parkinsonism, ALS, or a
dementia subtype which is not related to PD).
Controls:
- Diagnosed with Parkinson*s disease at the time of inclusion;
- Blood relative or spouse of a case selected by the same department of
neurology to prevent over matching;
- Initially diagnosed elsewhere and referred to one of the participating
hospitals for follow-up care or a second opinion;
- Other neurodegenerative diseases (e.g. atypical parkinsonism, ALS, dementia)
at time of inclusion.
Design
Recruitment
Medical products/devices used
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 | NL86526.091.24 |