The aim of this study is to investigate alterations in brain activity in UF patients by detecting and characterizing MEG changes, using network theory.
ID
Source
Brief title
Condition
- Angioedema and urticaria
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Difference in local and global connectivity between UF patients and healthy
controls during the baseline measurement
- Difference in local and global connectivity between UF patients and healthy
controls after a histamine prick test
- Difference in local and global connectivity between UF patients and healthy
controls after dermography
Secondary outcome
- Differences in the itch score (VAS) before and after a histamine prick test
and dermography, DASS and serum levels of CRH, ACTH, prolactine, cortisol,
NGF, BDNF, SP between UF patients and the control group.
- Correlation between *global connectivity* after a histamine prick test and
the itch score (VAS), area of a histamine prick test wheal and flare, UCT,
CU-Q2oL, DASS and serum levels of CRH, ACTH, prolactine, cortisol, NGF, BDNF,
SP.
- Correlation between *global connectivity* after dermography and the itch
score (VAS), width of the dermography wheal, UCT, CU-Q2oL, DASS and serum
levels of CRH, ACTH, prolactine, cortisol, NGF, BDNF, SP
In case of detectable regional differences in connectivity measures after a
histamine prick test or dermography between UF patients and the control group:
- Correlation between *local connectivity* after a histamine prick test and the
itch score (VAS), area of a histamine prick test wheal and flare, UCT, CU-Q2oL,
DASS and serum levels of CRH, ACTH, prolactine, cortisol, NGF, BDNF, SP.
- Correlation between *local connectivity* after dermography and the itch score
(VAS), width of the dermography wheal, UCT, CU-Q2oL, DASS and serum levels of
CRH, ACTH, prolactine, cortisol, NGF, BDNF, SP.
*
Background summary
Chronic urticaria, which is appearing in different forms, is a common disease.
In this research urticaria factitia (UF), which is precipitated by stroking or
scratching, will be examined. In all forms of urticaria the etiology is still
unknown. In chronic urticaria, as in other skin diseases, psychological stress
is an important contributing factor. Besides, recent research has been done in
the relationship between brain activity and skin disease, where by means of
functional MRI (fMRI) was demonstrated that some brain regions are more or less
activated in atopic dermatitis patients compared to healthy controls. With this
knowledge a role for the brain in urticaria is hypothesized. Understanding the
origin of urticaria factitia with the use of MEG (magnetoencephalography, a
recording of magnetic fields related to brain activity) and modern network
theory can help to unravel the etiology of urticaria factitia
Study objective
The aim of this study is to investigate alterations in brain activity in UF
patients by detecting and characterizing MEG changes, using network theory.
Study design
This investigation is a hypothesis inducing study on which the 'proof of
concept' approach is applicable since there is no previous study on this topic.
MEG and modern network theory is used to study functional network alterations
in UF patients compared to healthy controls.
Intervention
Three conditions are studied during the MEG-measurement: baseline situation,
local whealing after a histamine prick test, and local whealing after stroking
(dermographism).
Study burden and risks
MEG measurements are non-invasive, taking approximately 1,5 hours, including
preperation and testing between the measures. The procedure is not painful in
any way, is not considered to be difficult or stressful, and has negligible
risks. The same holds true for histamine prick testing and dermography. The
participants are asked to visit VU Medical Centre for the investigations. There
is no individual benefit from the MEG. The MEG recordings have a higher spatial
resolution compared to the conventional electroencephalography (EEG). Since MEG
measures brain activity directly, MEG is favoured compared to fMRI. Total visit
time: 2,5 hours.
De Boelelaan 1118
Amsterdam 1081HZ
NL
De Boelelaan 1118
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
UF diagnosed by a dermatologist, in active phase, i.e., wheals arise when antihistaminic drugs are stopped
18 years or older
informed consent given
Exclusion criteria
Age < 18 years
Participants that cannot read, speak or understand Dutch
Mentally incompetent individuals who are not capable to provide informed consent, as determined by their treating physician
Conditions that will cause excessive MEG artefacts (cardiac pacemaker/cardiac or neural defibrillators, metal fragments in the eyes, metal plates, piercings, pins or bolts in head, any magnetic implantation/implantations made from iron (ferrous products)
Systemic medication: corticosteroids, ciclosporine, montelukast, hydroxychloroquine, dapson, omalizumab, methotrexate
The antihistaminic drug should be stopped 4 days in advance
For healthy controls: participants with a history of any form of urticaria and participants who use antihistaminic 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 | NL58260.029.16 |