Primary objective: - To measure infraslow EEG changes during stress response in healthy subjects.Secondary objective(s):- To investigate if cortisol levels relate to ISA.- To explore ISA activity as a potential biomarker for stress.- To formulate…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Stress
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure will consist of changes in infraslow EEG activity
after stress in comparison with a control at rest.
Secondary outcome
Secondary outcomes consist of relating ISA to cortisol levels, and differences
between responses to stress induced by the ice-water test and stress induced by
physical exercise.
Background summary
Stress affects brain function in various ways. It is also associated with an
increased likelihood of seizures in patients with epilepsy. The pathophysiology
of this relationship is not well understood. A candidate mechanism is infraslow
brain activity. Very slow brain oscillations with frequencies below 0.1Hz have
been reported to be increased during stress and recently we and others have
shown that this infraslow activity (ISA) is associated with fluctuations in
cortical excitability. We further hypothesize that ISA is influenced by the
stress hormone cortisol.
Here, we will study the relationship between ISA and stress by exposing healthy
volunteers to two different stressors: the ice water test and strenuous
physical exercise. If this relationship between stress and ISA is indeed shown
in this study, this may explain the decreased seizure threshold in patients
with stress-related seizures and also offers potential as a novel biomarker for
stress related cerebral pathology.
Study objective
Primary objective:
- To measure infraslow EEG changes during stress response in healthy subjects.
Secondary objective(s):
- To investigate if cortisol levels relate to ISA.
- To explore ISA activity as a potential biomarker for stress.
- To formulate hypotheses about the generators of ISA.
Study design
This is a randomised crossover pilot that will run for 20 weeks.
Intervention
- Ice-water test
- Physical exercise test
Study burden and risks
Each subject will undergo two EEG measurements, during which he will experience
stress. In the first measurement, stress will be induced by submerging a hand
in ice-cold water. In the second measurement, the subject will perform
strenuous physical exercise.
EEG is a routine, everyday investigation. Serious or major adverse events are
not expected and the risk of an increase of morbidity or mortality is
negligible. Potential detrimental effects are discomfort and local skin defects
caused by the EEG electrodes. In case of important skin defects, or distress,
electrodes will be removed.
A physical exercise test is generally safe, and complications are rare. But, as
with any medical procedure, there is a risk of complications, including low
blood pressure, arrhythmias and an exceedingly small chance of myocardial
infarction. However, these complications are comparable to regular strenuous
exercise such as ascending a staircase or jogging.
Koningsplein 1
Enschede 7512KZ
NL
Koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
Above 18 years of age.
Exclusion criteria
Neurological disorder (e.g. epilepsy).
Pathology that influences EEG registration.
Cardiac or respiratory diseases resulting in limited exercise tolerance.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL64173.044.17 |
| OMON | NL-OMON21197 |