Our primary objectives are to study: 1) differences in the brain*s sensitivity to the effects of light on emotional processing in people with PD and people with depressive symptoms compared with healthy controls 2) whether different spectrum of…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our main study endpoints include 1) Blood Oxygenation Level Dependent Signal
(BOLD) in people with PD and persons with symptoms of depression compared with
controls
Secondary outcome
2) PD and depressive symptoms and their correlation to brain sensitivity to
light; 3) Anatomical connectivity as measured with diffusion tensor imaging
(DTI); 4) Daily subjective mood and its correlation to 24-hour ambient light
exposure patterns and body temperature rhythm, the sleep wake cycle and brain
sensitivity to light.
Background summary
Low or disorganised patterns of light exposure have been associated with both
mood and sleep disturbances. In Parkinson*s disease (PD) which is traditionally
treated with dopamine replacement and deep brain stimulation, neuro modulation
through the visual system is becoming a viable non-invasive alternative for
treating the non-motor (enhance mood and attenuate sleep disturbances) and
motor symptoms of PD. Light ameliorates disturbances of mood, sleep and
performance in elderly people with major depression. The neurobiological
mechanisms underlying the positive effects of light in PD and depression remain
poorly understood. Therefore, further work is required to better understand how
light modulates brain activations in response to different emotional valence in
persons with PD and in persons with symptoms of depression .
Study objective
Our primary objectives are to study: 1) differences in the brain*s sensitivity
to the effects of light on emotional processing in people with PD and people
with depressive symptoms compared with healthy controls 2) whether different
spectrum of light modify emotional brain responses; 3) determine whether the
magnitude of post-illumination pupil response and PD/depressionsymptoms
severity correlates with the effects of blue light (as opposed to red light) on
emotional brain responses. Secondary objective : 1) determine if the
association between affective state, sleep and ambient light in the natural
environment are mediated by the degree of sensitivity of the brain to light.
Study design
Case-control study involving 10-days of ambulatory monitoring, followed by an
MRI session and pupillometry.
Study burden and risks
This study involves 2 site visits and 10 days of ambulatory monitoring. Total
participation time is approximately 7 hours (including components done at
home). Overall, the risk associated with participation can be considered
negligible and the burden can be considered modest.
For the multi-parameter ambulatory recording, participants will wear
thee small non-invasive and nonintrusive integrated sensors and recorders.
Wearing of these ambulatory sensors is of negligible burden and without risk.
To avoid any risk during light stimulation, the maximum intensities of
the light source in the set-up are well below the recommendations of the
American National Standard (ANSI-2007) for red, blue and white illumination.
These sub-threshold intensities, in combination with the limited exposure
durations, and exclusion of participants with increased retinal sensitivity to
light, will eliminate any risk associated with bright light exposure.
In the PD group the fMRI experiment is conducted while patients are at
the end of their regular dopaminergic medication cycle (i.e., while
experiencing the end-of-dose phenomenon), because this closely resembles the
real-life clinical situation. As in their usual daily life participants are
likely to experience increased PD symptoms end-of-dose which will directly
resolve upon intake of their usual medication after the assessment. No risks
are associated with a transient end-of-dose state and this is common practice
in PD research.
Oldenaller 1
Amsterdam 1070 BB
NL
Oldenaller 1
Amsterdam 1070 BB
NL
Listed location countries
Age
Inclusion criteria
Depression:
- Age > 40 years
- Significant symptoms of depression (score > 13 on the Inventory of Depressive Symptomatology (IDS-SR))40
- Symptomatic on the depression part of the Composite International Diagnostic Interview * Short Form (CIDI-SF)41
- Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements.;PD:
- Age > 40 years
- Idiopathic PD, as diagnosed by the UK Brain Bank Criteria
- Mild PD stage 1-3, based on Hoehn & Yahr scale
- Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements
- MMSE 24;Control:
- Age > 40 years
- Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements.
Exclusion criteria
PD
- Early onset PD (< 40 years)
- Treatment with continuous apomorphine infusion, intestinal duodopa therapy or deep brain stimulation (DBS);- PD patients with excessive tremor.;Control:
- Current or past psychiatric diagnosis
- Significant symptoms of depression (score > 13 on the IDS-SR)
- Symptomatic on the CIDI-SF.;All groups
- Current diagnosis of bipolar disorder, psychotic disorder, alcohol or substance dependence, or any cognitive disorder
- Neurological disease (other than PD for the PD group) stroke or major head trauma, current or in history
- MRI contraindications such as metal implants, claustrophobia, left-handedness, pregnancy
- Self-reported inability or unease to cease smoking for 24 hours prior to testing
- Current treatment with tricyclic antidepressant or antipsychotic medication
- Ophthalmic disorder, color blindness, severe visual impairment or auditory impairment
- Travel to a different time zone within the last month
- Night work or rotating shift work.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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In other registers
Register | ID |
---|---|
CCMO | NL61308.029.17 |