The primary objective of this study is to investigate fatigue related brain activation in individuals with high fatigue complaints compared to individuals with low fatigue complaints. Furthermore, the impact of induced fatigue will be examined in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
vermoeidheidsklachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are reaction times, accuracy and brain activation
during the neuroimaging sessions.
Secondary outcome
Secondary parameters are scores on the questionnaires used for pre-selection,
salivary cortisol levels, Hb-values and other control variables.
Background summary
Fatigue is a common complaint in the healthy population with strong adverse
effects on the quality of life. However, it is difficult to assess fatigue
objectively as subjective complaints of fatigue and behavioural performance do
not correlate well. Based on literature on fatigue in clinical populations it
is suggested that fatigue may be related to higher mental effort in terms of
increased brain activation.
Study objective
The primary objective of this study is to investigate fatigue related brain
activation in individuals with high fatigue complaints compared to individuals
with low fatigue complaints. Furthermore, the impact of induced fatigue will be
examined in both groups.
Study design
A controlled, randomized crossover design is used for this study, with long
term fatigue as between subjects variable and induced fatigue as within
subjects variable. Volunteers are selected based on the results of the
Checklist Individual Strength and allocated to groups. Neuroimaging will take
place during the execution of cognitive tasks and a resting period.
Intervention
The participants are subjected to a fatigue-intervention and a
relaxation-intervention. During the fatigue-intervention, the participants will
perform several cognitively demanding task continuously for 1,5 hours. During
the relaxation-manipulation, the participants are offered several magazines and
asked to relax for 1,5 hours.
Study burden and risks
The burden and risks associated with participation in this study are minimal.
The fMRI session may cause slight discomfort since the subjects are to remain
as motionless as possible and the scanner environment is noisy. To minimize the
burden, scanning time is limited to one hour.
Van der Boechorststraat 1
1081 BT Amsterdam
NL
Van der Boechorststraat 1
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
relevant scores on the fatigue questionnaire
fatigue complaints longer than 2 months
good health
normal hearing ability
normal or corrected to normal vision
right-handedness
Exclusion criteria
hearing problems
uncorrected vision problems
use of medication or drugs
excessive alcohol intake
(a history of) neurological or psychiatric problems
fatigue-related illness
any fMRI contra-indications (eg. metal parts in the body)
individuals currently under medical treatment
smokers (on a daily basis)
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 | NL37009.029.11 |