cluster headache
Conditions
Interventions
Surgery
All patients will undergo occipital Nerve Field Stimulation implant procedure.
The eligible patient will have the procedure under general anaesthesia and
antibiotic prophylaxis (Cephalozin 1
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • ICHD-II criteria for Chronic Cluster Headache • Minimum mean attack frequency of 4 attacks per week • Minimum age of 18 years old • Signed study specific informed consent form agreeing to implantation of the device, data collection and follow-up requirements • Agreeing to refrain from starting new prophylactic CH medication, including steroids, or any other therapy aimed at CH (such as acupuncture, biofeedback, chiropractic, or massage) 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 not older than 4 years prior to enrolment must be available to exclude structural lesions potentially causing CCH. MRA of head and neck are to be performed according to study physician*s individual judgement. • Medically intractable (see below) 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);1 Verapamil 2 Lithium 3 Methysergide 4 Topiramate 5 Gabapentin
Exclusion criteria
Exclusion criteria: • Other significant neurological or disabling diseases (including other forms of TAC) 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 (use on 10 or more days per month) 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 trigeminal nerves • Enrolment in other clinical studies (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the study or within four weeks prior to his/her enrolment in the 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the mean attack frequency (MAF) over the last 4 weeks in the 100% and the 30% treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| MAF: We will repeat the primary analysis, with the MAF as outcome instead of the logarithm of the MAF. MAF during follow-up: The MAF for each 4 week period. Mean attack intensity: The mean attack intensity (on a scale from 0-10) will be calculated over the last 4 weeks for each group at baseline, 6 and 12 months follow up and will be compared between and within the 2 groups. Responder rate: Rate of responders (>50% reduction in attack frequency in the last 4 weeks compared to baseline) will be calculated and compared between groups at 6 and 12 months. Economic evaluation Anticipated group randomisation: The patient and assessors will be asked at 6 months follow-up (after deblinding), in which treatment group (high or low stimulation) they think the patient was allocated. Awareness of paraesthesias: localisation and strength will also be evaluated weekly and coded through the patients* recordings in the electronic diary and compared with effectiveness of stimulation, e.g. frequency of attacks. The use of acute attack medication: The number of doses of sumatriptan injections or intranasal spray or O2 will be investigated and calculated of the last 4 weeks of each treatment period and the baseline period, and compared between and within groups. Patient satisfaction: We will ask the patient at 6 and 12 months follow-up whether he/she would recommend the treatment to another patient using a 4 point scale: strongly, moderately, mildly or not recommended. Responder identification: It is also investigated whether predictive factors can be identified with respect to the outcome in a hypothesis generating manner. Adverse events: All and treatment-related adverse events will be documented by the investigators. | — |
Countries
Netherlands
Outcome results
None listed