Occipital Nerve Stimulation in Medically Intractable Chronic Cluster Headache (ICON)
Chronic Cluster Headache
About this trial
This is an interventional treatment trial for Chronic Cluster Headache
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of patients with CH shall be in accordance with The International Classification of Headache Disorders, 2nd Edition:
A. At least 5 attacks fulfilling criteria B-D B. Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated
C. Headache is accompanied by at least 1 of the following:
- ipsilateral conjunctival injection and/or lacrimation
- ipsilateral nasal congestion and/or rhinorrhoea
- ipsilateral eyelid oedema
- ipsilateral forehead and facial sweating
- ipsilateral miosis and/or ptosis
a sense of restlessness or agitation D. Attacks have a frequency from 1 every other day to 8 per day E. Not attributed to another disorder
- Chronic cluster headache A. Attacks fulfilling criteria A-E for Cluster headache B. Attacks recur over >1 year without remission periods or with remission periods lasting <1 month
- ICHD-II criteria for CCH (see above)
- Minimum mean attack frequency of 4 attacks per week
- Minimum age of 18 years old
- Signed study specific informed consent form
- Agreeing to refrain from starting new prophylactic CH medication, including steroids, or any other therapy aimed at CH and agrees to maintain existing prophylactic CH medication from 4 weeks before entering the baseline period throughout the duration of the double blind phase of the study. It is allowed to change the dose of prophylactic medication during the study based on the opinion of the treating medical specialist.
- Availability during follow-up period
- An MRI to exclude structural lesions potentially causing CCH.
- Medically intractable (see below)
Definition medically intractable :
Failed adequate trials of regulatory approved and conventional treatments according to local national guidelines
Adequate trial:
Appropriate dose and duration of treatment according to local guidelines Appropriate length of time Consideration of medication overuse
Failed:
No therapeutic or unsatisfactory effect, intolerable side effects, contraindications to use
Must have tried agents of at least three classes of the following, of which 1 and 2 are obligatory, and 1 should come from 3-5: (recommendation of Goadsby et al. applied to Dutch national guidelines)
- Verapamil
- Lithium
- Methysergide
- Topiramate
- Gabapentin
Exclusion Criteria:
- Other significant neurological or disabling diseases which in the opinion of the clinician may interfere with the study
- Pregnancy or the wish to become pregnant during the study period
- Cardiac pacemaker and other neuromodulatory devices
- Psychiatric or cognitive disorders and/or behavioural problems which in the opinion of the clinician may interfere with the study
- Taking CH prophylactic medication for conditions other than CH which in the opinion of the clinician may interfere with the study
- Serious drug habituation and/or overuse of acute headache medication for other headaches than CH
- Inability to complete the (electronic) diary in a sensible and accurate manner
- Structural intracranial or cervical vascular lesions that may potentially cause CH
- Previous destructive surgery involving the C2 or C3 roots (vertebrae) or deep brain stimulation
- Enrollment in other clinical studies that may confound the results of this study
- Requiring anticoagulation therapy or antithrombotic or thrombocyte aggregation-inhibitor for a concomitant condition that cannot be stopped peri-operatively. The local peri-operative protocol of each individual participating centre will be followed
Sites / Locations
- CHR La Citadelle hospital
- Schmerzklinik Kiel
- National Institute of Neuroscience
- Boerhaave MC
- Atrium medical centre
- Leiden University Medical Center
- Canisius Wilhelmina Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
100% occipital nerve stimulation
30% occipital nerve stimulation
Stimulation frequency and pulse width will be uniformly held constant at 60 Hz and pulse width at 450 ms. The perception and discomfort amplitude will be defined by increasing the stimulation amplitude in steps of 0.1 V. The amplitude at which the patient starts feeling paraesthesis is called the perception threshold. The threshold at which the patient does not want the voltage to be increased any further because of painful sensations is designated the discomfort threshold. 100% stimulation is defined as stimulation at 90% of the range between perception and discomfort thresholds.
30% stimulation means a stimulation level at 30% of the range between perception threshold and 100% stimulation level