To investigate if the GON-injection affects trigeminal threshold and transmission using the R2 component of the blink reflex.
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is the difference in mean ipsilateral R2
latency of the blink reflex between the one-week and baseline timepoint.
Secondary outcome
* Clinical response to GON-injection as measured by daily attack frequency,
attack intensity and duration
* The association between the mean ipsi- and contralateral R2 latency of the
blink reflex and the clinical response, as measured in percentage change in
attack frequency, to the GON-injection
* The association between the mean ipsi- and contralateral AUC of the blink
reflex and the clinical response to the GON-injection
* The change in ipsi- and contralateral mean R2 latency and mean AUC between
all 4 time points
* The difference in mean trigeminal sensible and pain threshold between all 4
time-points
* The association between trigeminal sensible and pain threshold and clinical
response to the GON-injection
Background summary
Cluster headache is a very severe primary headache disorder. At present, the
pathophysiology of cluster headache is unknown. Three key components have been
identified, the trigeminovascular system, the parasympathetic nerve fibers and
the hypothalamus, but the exact cause of the disease remains to be identified.
Management of cluster headache entails a combination of attack and prophylactic
treatment. Evidence has emerged that local steroid injection of the greater
occipital nerve (GON) may be effective in the prevention and prophylactic
treatment in cluster headache. The mechanism of action of GON-injection is not
clear. We aim to investigate the mechanism of action and possible predictive
parameters of effect by assessing trigeminal nerve transmission and local
sensory and pain threshold. We will use the blink reflex, more specifically the
R2 component of the blink reflex, as a way of measuring the trigeminal nerve
transmission.
Study objective
To investigate if the GON-injection affects trigeminal threshold and
transmission using the R2 component of the blink reflex.
Study design
Single center, prospective cohort study with 12 weeks follow-up.
Intervention
GON-injection (as part of regular treatment)
Study burden and risks
The risks of the proposed study are very low. The blink reflex is a
electrophysiological measurement and has been conducted since the 1970s. The
current and voltage required for the measurements are extremely low. If
patients agree to participate, participants need to spent 2 hours extra on the
first visit (in which the GON-injection will be administered) when the first
two measurements will be conducted. The third visit can be simultaneous with a
consultation with their neurologist to evaluate the effect of the
GON-injection.
This study can provide valuable new insights in the therapeutic effect of the
GON-injection and can hopefully increase our knowledge of cluster headache
pathophysiology.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Patients have to be diagnosed with episodic or chronic cluster headache
according to the international classification of headache disorders * third
edition, ICHD-3
- Patients have to be aged 18-75 years
- Patients should be receiving a GON-injection as regular therapy for episodic
or chronic cluster headache
Exclusion criteria
Treatment with a SPG-stimulator or an occipital nerve stimulator
Design
Recruitment
metc-ldd@lumc.nl
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 | NL71803.058.19 |