The first objective of this study is to assess whether emotional responsiveness in PD patients is different from that of matched healthy controls and whether emotional responsiveness in PD patients with apathy is different from that in PD patients…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In this study the main parameters is emotional responsiveness measured on a
visual analogue (VAS) scale.
.
Secondary outcome
Physical concomitants of emotional responsiveness: heart rate, blood pressure,
skin conductance and pupil width
Salivary cortisol levels will be measured at the beginning of the study and
after emotional pictures are viewed.
Performance on neuropsychiatric and neuropsychological questionnaires and tests
Background summary
Apathy is a neuropsychiatric syndrome defined as a lack of motivation
characterized by reduced goal-directed behavior, reduced goal-directed
cognitive activity and a decreased spontaneous emotions or emotional
responsiveness to positive and negative stimuli and events. In Parkinson*s
disease (PD) it is associated with greater cognitive dysfunction, worse
performance of activities of daily living and reduced quality of life. The
pathophysiology of apathy is not well studied. Studies addressing emotional
responsiveness in PD may provide new insights into the neurobiology of apathy,
which may eventually lead to new treatment strategies and an improved quality
of life for PD patients suffering from apathy.
Study objective
The first objective of this study is to assess whether emotional responsiveness
in PD patients is different from that of matched healthy controls and whether
emotional responsiveness in PD patients with apathy is different from that in
PD patients without apathy.
Study design
This is a cross-sectional study which will follow a two stage approach;
1. The present study is done to assess emotional responsiveness and to
investigate differences in emotional responsiveness between PD patient and
healthy controls and between PD patients with apathetic symptoms and PD
patients without apathetic symptoms.
2. After the present study, a functional MRI study is done to identity
differences in activation of specific brain structures involved in emotional
responsiveness in PD patients with and without apathetic symptoms and healthy
controls
Study burden and risks
The burden and risks associated with the present study are minimal. For this
study participants will spend approximately 1.5 hour at the MUMC. It is
unlikely that the neuropsychiatric assessment will cause any harm to
participants.
po box 616
6200 MD Maastricht
NL
po box 616
6200 MD Maastricht
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for PD patients are:
-Idiopathic Parkinson*s disease according to the Queen Square Brain Bank criteria (De Rijk, Rocca et al, 1997).
-The use of a stable dose of antiparkinsonian medication.
-Signed informed consent;Inclusion criteria for healthy controls are:
-signed informed consent
Exclusion criteria
Exclusion criteria for PD patients are:
-patients with other neurodegenerative disorders other than PD
-Major Depressive Disorder as defined by the criteria of the fourth edition of the Diagnostic and Statistical Manual (DSM-IV) of the American Psychiatric Association (APA) (American Psychiatric Association 1994).
-cognitive deterioration operationalised as a score of <26 on the Mini Mental State Examination (MMSE) (Folstein, Folstein et al. 1975) or fulfilling diagnostic criteria for Parkinson*s Disease Dementia (PDD) (Dubois, Burn et al. 2007).
-use of psychopharmacological medication, with the exception of benzodiazepines
-abuse of alcohol and/or drugs
-exclusion criteria for MRI scanning;Exclusion criteria for healthy controls are:
-neurodegenerative disorders
-Major Depressive Disorder as defined by the criteria of the fourth edition of the Diagnostic and Statistical Manual (DSM-IV) of the American Psychiatric Association (APA) (American Psychiatric Association 1994).
-cognitive deterioration operationalised as a score of <26 on the Mini Mental State Examination (MMSE) (Folstein, Folstein et al. 1975) or fulfilling diagnostic criteria for Parkinson*s Disease Dementia (PDD) (Dubois, Burn et al. 2007).
-use of psychopharmacological medication, with the exception of benzodiazepines
-abuse of alcohol and/or drugs
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 | NL33147.068.10 |