[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599683":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":25,"responsibleParty":35,"collaborators":25,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":25,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":25,"enrollmentInfo":46,"targetDuration":25,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":25},{"fullName":5,"class":6},"University College, London","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ONS using tonic stimulation with Prodigy Internal Pulse Generator","ACTIVE_COMPARATOR","Tonic stimulation provides continuous electrical stimulation with perceptible paraesthesia to the occipital region. It is the standard of care at present in this unit and in most published studies of ONS.",[13],"Device: Prodigy internal pulse generator occipital nerve stimulator",{"label":15,"type":16,"description":17,"interventionNames":18},"ONS using BurstDR microdosing stimulation with Prodigy Internal Pulse Generator","EXPERIMENTAL","BurstDR microdosing provides pulses of stimulation at a lower amplitude but higher frequency and a larger pulse width than Tonic stimulation. The stimulation is not perceptible to the patient and there is no paraesthesia. Early reports of spinal cord stimulation and suggest it may be preferable for patients and does not have any serious adverse effects.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Prodigy internal pulse generator occipital nerve stimulator","Electrical stimulation of the occipital nerves using an implantable device",[15,9],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Manjit Matharu, BSc, MBChB, PhD, FRCP","CONTACT","+44020 3448 3664","manjit.matharu@ucl.ac.uk",{"name":33,"role":29,"phone":25,"phoneExt":25,"email":34},"Lucy Simmonds, BMedSci, BMBS, MRCP","lucysimmonds@nhs.net",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100599683","occipital-nerve-stimulation-in-chronic-migraine-100599683",false,"NCT07087678","Occipital Nerve Stimulation in Chronic Migraine","A Prospective, Randomised, Open Label Feasibility Trial Comparing BurstDR Microdosing Versus Tonic Occipital Nerve Stimulation for Patients With Refractory Chronic Migraine","Inclusion Criteria:\n\nAge ≥ 18 years old and diagnosed with intractable chronic migraine by a headache specialist, as defined by the International Classification of Headache Disorders-3 (ICHD-3).\n\nSubject should have failed to gain benefit from at least 4 classes of oral preventative medications, Botulinum toxin or acupuncture as defined by NHS (National Health Service) England Subject has been diagnosed at least 6 months prior to study enrolment with migraine headache with or without aura according to the ICHD-3 criteria 1.1, 1.2.1, or 1.3.\n\nSubject is able to distinguish migraine attacks from other headaches (e.g. tension type headache, cluster headaches).\n\nSubject agrees to not participate in supplemental or alternative therapy through the Follow Up Period of the study. This includes acupuncture, spinal manipulation, TENS (transcutaneous electrical nerve stimulation), and magnetic fields treatments.\n\nSubject has the ability to read, comprehend, and to reliably record information as required by the Protocol.\n\nSubject is able to provide written informed consent prior to participation in the study.\n\nExclusion Criteria:\n\nSubject's overall health, age and\u002For comorbidities place subject at high risk for complications from surgery and\u002For general anaesthesia.\n\nSubject has clinically significant drug (including opioid) or alcohol abuse as defined by DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision), will likely be unable to refrain from substance abuse throughout the study, has another significant pain problem, substance abuse or active depressive episode that might confound the study assessments in the opinion of the Investigator.\n\nSubject is currently participating or has participated in the last month in another clinical study in which the subject has, is, or will be exposed to, an investigational drug or device, except for sponsor-related studies.\n\nSubject is felt to be at risk of non-compliance (e.g., for completing the diary\u002Fquestionnaires or returning for required follow-up visits) in the Investigator's opinion.\n\nSubject has medication overuse headache which has not been managed (by withdrawal of the causative medication).\n\nSubject is a woman of childbearing potential who is pregnant, nursing, or not using effective contraception.\n\nSubject has an active implantable device such as pacemaker\u002F defibrillator or other neurostimulation device.\n\nSubject has a history of bleeding disorders or coagulopathy or is unable to discontinue anticoagulation, antiplatelet, or GP (glycoprotein) IIb IIIa inhibitor medication in preparation for the implantation procedure.\n\nSubject is not suitable for the study for any reason in the judgment of the Investigator.","ALL","18 Years",{"count":47,"type":48},40,"ESTIMATED","INTERVENTIONAL",[51],"NA","The goal of this clinical trial is to compare two different types of occipital nerve stimulation (BurstDR (dorsal root) microdosing versus Tonic) in chronic refractory migraine. The main questions it aims to answer is whether BurstDR microdosing is effective in reducing moderate to severe headache days compared to Tonic stimulation (which is currently in use). Additionally, the safety of both types of stimulation will be studied.\n\nParticipants will be asked to keep a headache diary, then have the device implanted and programmed, and keep a subsequent headache diary to see if there is an improvement in their headaches after three moths of stimulation. If they don't respond to treatment, they will be allowed to swap to the other type of stimulation to see if this improves their symptoms.",[54,55],"Chronic Migraine, Headache","Refractory Migraine",[57,58,59,60],"Chronic migraine","Occipital nerve stimulation","BurstDR microdosing","Refractory migraine","NOT_YET_RECRUITING","2025-07-18",{"date":64,"type":65},"2025-07-28","ACTUAL",{"date":67,"type":48},"2025-09-01",{"date":69,"type":48},"2028-06-01",{"name":5,"class":6}]