Cluster headache Suicide headache
Conditions
Interventions
All subjects will receive four-electrode ONS, meaning that four electrodes with 4-poles (standard ONS electrode design) will be implanted. Similar to the usual ONS approach, electrodes will be inserte
Sponsors
Canisius Wilhelmina Ziekenhuis (CWZ)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: International classification of headache disorders-II (ICHD-II) criteria for chronic cluster headacheAt least 18 years oldMedically intractable: having failed adequate prior trials of verapamil and lithium and one of methysergide, toparimate or gabapentineMean attack frequency at baseline at least 4 attacks/weekProvided informed consentAvailability during follow-up periodMRI of head and neck are to be performed according to study physician’s individual judgementAn MRI not older than four years prior to enrolment must be available to exclude structural lesions potentially causing cluster headache attacks. An exception can be made in case of stable cluster headache for over four years and no change in symptoms after the last MRI scan was performed
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Inability to complete the (electronic) diary in an accurate mannerPrevious destructive surgery involving the C2 or C3 roots (vertebrae) or deep brain stimulationStructural intracranial or cervical vascular lesions that may potentially cause cluster headacheRequiring anticoagulation therapy or antithrombotic or thrombocyte aggregation inhibitor for a concomitant condition that cannot be stopped peri-operatively. The local per-operative protocol of each individual participating centre will be followedEnrolment in other clinical studies which in opinion of the study clinician may confound the results of this studyOther significant neurological or disabling diseases (including other forms of autonomic cephalalgias) which in the opinion of the clinician may interfere with the studyCardiac pacemaker and other neuromodulatory devicesPregnancySerious drug habituation and/or overuse of acute headache medication (use on 10 or more days per month) for other headaches than cluster headache (excessive use of triptans for cluster headache attacks is not an exclusion criterion)Taking cluster headache prophylactic medication for conditions other than cluster headache which in the opinion of the clinician may interfere with the studyPatients not understanding and/or speaking the Dutch language.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters for safety are the occurrence of adverse events. For feasibility it is the duration of the surgery and the implanting experience with protocol by implanting surgeon. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other study parameters are the percent change in frequency, intensity (Numeric Rating Scale, NRS) and duration of CH attacks, medication intake, 12-Item Short Form Survey (SF-36)(QoL), Pain Catastrophizing Scale (PCS) (emotional distress) and the Hospital Anxiety and Depression Scale (HADS)(emotional distress) from baseline. Further, patient satisfaction, patient experiences and duration of post-operative hospital admission will also be evaluated. Outcomes obtained from four 4-pole ONS will be compared to previously collected data from patients with CH undergoing two 4-pole ONS after January 1st 2022 in Canisius Wilhelmina Hospital (CWZ). | — |
Countries
Netherlands
Contacts
Public ContactE Kurt
Radboud Universitair Medisch Centrum
Outcome results
None listed