The goal of this research is to assess whether cognitive effort (mental arithmetic) or fear (threat of shock) have a similar or different effect on Parkinson*s tremor and noradrenergic activity. In the following, obtained knowledge and empirical…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
During each of the three behavioral tasks we will record the following primary
outcome measures:
- Tremor power (quantified using accelerometry and EMG)
- Pupil diameter (a marker of noradrenergic activity; quantified using eye
tracking)
Secondary outcome
Additionally, we will obtain measure of:
- Task performance (using choice and reaction times)
- Heart rate (quantified using ECG)
- Disease severity (UPDRS part III and TRS)
Background summary
Parkinson*s disease is the second most common neurodegenerative disease
worldwide. Clinically, Parkinson*s disease is characterized by motor slowing
(bradykinesia), stiffness (rigidity) and resting tremor. The pathological
hallmark of Parkinson*s disease is striatal dopamine depletion, but the
dopaminergic basis of resting tremor is disputed. For instance, striatal
dopamine depletion correlates with all motor symptoms except resting tremor.
Furthermore, resting tremor is often resistant to dopaminergic medication.
Instead, resting tremor worsens consistently during psychological stress, and
recent findings suggest that the noradrenergic (stress) system is hyperactive
in Parkinson*s disease. However, it is not clear which type of stress
(cognitive effort, fear) has the largest effect on Parkinson*s tremor.
Study objective
The goal of this research is to assess whether cognitive effort (mental
arithmetic) or fear (threat of shock) have a similar or different effect on
Parkinson*s tremor and noradrenergic activity. In the following, obtained
knowledge and empirical evidence will be used to prepare an amendment for a
follow-up fMRI study, which will be investigating how enhanced noradrenergic
activity modulates Parkinson*s tremor (CMO 2016-3101).
Study design
Cross-sectional observational study
Study burden and risks
This research involves capacitated adults. This research has no direct benefit
for the participants. The scientific benefit of this study is to achieve a
better understanding of the pathophysiology of a severe symptom (Parkinson's
tremor).
There is minimal risk and minimal burden associated with this experimental
protocol. The protocol will be performed during one session (duration
approximately 3 hours). It will consist of clinical measurements and behavioral
performance of three cognitive tasks as well as recording of autonomic
responses. This study is purely observational, i.e., no invasive or
interventional procedures are involved. Patients taking dopaminergic medication
will be asked to delay one dose (i.e. the morning dose) until after the
experiment. This may temporarily worsen Parkinson symptoms, but we will
minimize this by only including patients with mild disease severity.
Kapittelweg 29
Nijmegen 6525 EN
NL
Kapittelweg 29
Nijmegen 6525 EN
NL
Listed location countries
Age
Inclusion criteria
- Idiopathic Parkinson*s disease according to UK brain bank criteria.
- Presence of a clear resting tremor of at least one arm (UPDRS tremor-score ><= 2).
- Mild phenotype (defined as Hoehn and Yahr stage < 3)
Exclusion criteria
- Neuropsychiatric co-morbidity
- Cognitive impairment (MMSE < 26)
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 | NL66771.091.18 |