Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care
Condition: Chronic Cluster Headache
MeSH terms: Cluster Headache; Headache
Intervention: GammaCore
Intervention description: vagal stimulation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: vagus nerve stimulation; vagal nerve stimulation; nVNS; VNS; cluster headache; chronic; non invasive; gammacore

Summary:

      Subjects enrolled into this 10 week study will for the first two weeks document the number of
      cluster headaches and the means of treating (medication) of these attacks. Subjects will then
      be randomized to into either two groups. The first group is continuing with standard of care
      and the second group is treatment with the investigational device (GammaCore) for a period of
      4 weeks. After this 4 week period, all subjects will treat with the GammaCore for another 4
      week period. It is hypothesized the the treatment group will have a reduction in mean cluster
      headaches per week by 50% compared to the standard of care group.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Signed Informed Consent Form 2. Subjects between the age of 18-70, both genders 3.
        Subjects diagnosed with chronic cluster headache for at least 1 year, without remission
        periods or with remission periods lasting <1 month, in accordance with the ICHD-II
        classification criteria (2ndEd):

        a. At least 5 attacks fulfilling the following criteria: i. Severe or very severe
        unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated
        ii. Headache is accompanied by at least 1 of the following:

          1. Ipsilateral conjunctival injection and/or lacrimation

          2. Ipsilateral nasal congestion and/or rhinorrhea

          3. Ipsilateral eyelid oedema

          4. Ipsilateral forehead and facial sweating

          5. Ipsilateral miosis and/or ptosis

          6. A sense of restlessness or agitation iii. Attacks have a frequency from 1 every other
             day to 8 per day and are not attributed to another disorder iv. Attacks recur over > 1
             year without remission periods or with remission periods lasting < 1 month.

        4. Has minimum mean attack frequency of 4 CH attacks per week. 5. Is able to distinguish CH
        from other headaches (i.e. tension-type headaches).

        6. Is capable of completing headache pain self-assessments. 7. Agrees to use the GammaCore®
        device as intended and follow all of the requirements of the study, including follow-up
        visit requirements.

        8. Is willing to keep all concomitant medication stable during the entire study period.

        9. Women of child-bearing potential must use 2 methods of contraceptive i.e. hormones and
        condom.

        Exclusion Criteria:

          1. Is currently taking CH prophylactic medication for indications other than CH which in
             the opinion of the clinician may interfere with the study

          2. Has had a change in type or dosage of prophylactic headache medications < 1 month
             prior to enrollment

          3. Has a history of intracranial or carotid aneurysm, intracranial hemorrhage, brain
             tumors or significant head trauma.

          4. Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal
             anatomy at the GammaCore® treatment site.

          5. Has other significant pain problem that might confound the study assessments in the
             opinion of the investigator.

          6. Has known or suspected severe atherosclerotic cardiovascular disease, severe carotid
             artery disease (e.g. bruits or history of TIA or CVA), congestive heart failure (CHF),
             known severe coronary artery disease or recent myocardial infarction (within 5years).

          7. Has had a previous unilateral or bilateral vagotomy.

          8. Has uncontrolled high blood pressure.

          9. Is currently implanted with an electrical and/or neurostimulator device, including but
             not limited to cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain
             stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.

         10. Has a history of carotid endarterectomy or vascular neck surgery on the right side.

         11. Has been implanted with metal cervical spine hardware or has a metallic implant near
             the GammaCore® stimulation site.

         12. Has a history, the last 12 month, of syncope.

         13. Has a history, the last 12 month of seizures.

         14. Has a known history or suspicion of substance abuse or addiction, or overuse of acute
             headache medication for headaches other than CH.

         15. Has psychiatric or cognitive disorder and/or behavioral problems which in the opinion
             of the investigator may interfere with the study

         16. In the opinion of the investigator the subject is incapable of operating the
             GammaCore® device as intended and performing the data collection procedures.

         17. Is participating in any other therapeutic clinical investigation or has participated
             in a clinical trial in the preceding 30 days.

         18. Woman who are pregnant or lactating.