To investigate whether stress (chronic and acute) influences cognitive functioning in PD.
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Different parameters for stress will be taken into account (cortisol levels,
scores on a perceived stress questionnaire). Furthermore, performance on
cognitive tasks will be assessed in the PD group and control group. Both groups
will be compared with each other. There will be assessed whether:
- stress (chronic and acute) influences cognitive functioning in PD
- chronic stress is associated with an accelerated cognitive decline in PD
Secondary outcome
Different parameters for stress will be taken into account (induced stress,
vulnerability to perceive stress). Furthermore, performance on cognitive tasks
as well as medical decision making tasks will be assessed in the PD group and
control group. Both groups will be compared with each other. There will be
assessed whether:
- induced stress influences cognitive functioning in PD
- vulnerability to perceive stress moderates the influence of (chronic and
acute) stress on cognitive functioning in PD.
- cognitive functioning mediates the influence of stress on medical decision
making in PD.
Background summary
Parkinson*s disease (PD) is a progressive neurodegenerative disorder. Besides
motor symptoms, cognitive impairments are well recognized. Cognitive impairment
occurs in approximately half of the PD population and is in most cases
progressive in nature. Over the course of the disease PD patients have to make
complex decisions about medical care. Research findings suggest that medical
decision making is affected in cognitive impaired PD patients. It remains
unclear which factors contribute to the progression of PD. Considering low
quality of life in PD patients with dementia, it is in particular interesting
whether psychological factors contribute to cognitive decline in PD. It is
known that minimal psychological stress can increase motor symptoms.
Furthermore, an association was found between neuroticism and increased risk of
PD. However, there are no studies conducted investigating the influence of
psychological stress on cognitive functioning in PD. As for the impact of
(chronic and acute) stress on cognitive functioning in other diseases, studies
indicate an association between stress and cognitive functioning. Since minimal
psychological stress increases motor symptoms in PD, we expect that
psychological stress also has an impact on cognitive functioning and therefore
also on medical decision making. This is important to PD patients and their
families, who have to make complex decisions about medical care over the course
of the progressive neurodegenerative disease. With regard to secondary
prevention of PD dementia, psychological interventions focusing on stress
management could have an important surplus value next to medical treatment.
Study objective
To investigate whether stress (chronic and acute) influences cognitive
functioning in PD.
Study design
Prospective longitudinal cohort study comparing PD patients to a healthy
control group.
Study burden and risks
Participants will be neuropsychological assessed twice (baseline and two year
follow-up). The duration of the neuropsychological assessment is approximately
150 min. Participants are also asked to take five salivary samples (cortisol
measurement) with swabs at home prior to the assessments (15 min.). Prior to
the baseline assessment participants are asked to fill out questionnaires at
home (30 min.). Between the baseline and follow-up neuropsychological
assessment participants are asked to fill out a stress questionnaire once every
two months at home. The time for filling out the questionnaire is estimated to
take 15 min. The neuropsychological assessment, taking salivary samples and
completing questionnaires will require a certain amount of concentration from
which a participant can recover after a short break. During the first
neuropsychological assessment, a neuropsychological task is conducted that will
be used as stress induction. After the assessment debriefing and a relaxation
exercise will take place to ensure participants go home relaxed. The risks of
the study are negligible. PD patients are used to neuropsychological assessment
in clinical practice. Participants will have no direct benefit from the study.
We consider the burden of the study worthwhile comparing to the gains of the
study. There is little to no knowledge about the influence of stress on the
course of PD. Research on this topic may have great implications for the
treatment of PD.
Henri Dunantstraat 5
6419 PC Heerlen
NL
Henri Dunantstraat 5
6419 PC Heerlen
NL
Listed location countries
Age
Inclusion criteria
- Parkinson's Disease according to the UKPDS Brain Bank Criteria as diagnosed by a neurologist.
- Stabel dosage of "anti-parkinsonian" medication at onset of the study
Exclusion criteria
- Surgical treatment for PD, such as deep brain stimulation.
- Suspected dementia at the onset of the study.
- Presence of co-morbid neurological disorder (e.g. CVA) or infection (e.g. meningitis) within last 5 years other than PD that influences cognitive functioning.
- Medication (e.g. corticosteroid) that influences daily cortisol levels.
- Presence of posttraumatic stress disorder and/or psychotic disorders which influences cognitive functioning.
- Depression according to the Beck Depression Inventory (BDI), cut-off score 15 for PD patients and cut-off score 10 for healthy controls.
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 | NL40173.096.12 |