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Non-invasive Neurostimulation of the Vagus Nerve for the Treatment of Cluster Headache (CH)

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ClinicalTrials.gov Identifier: NCT01792817
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
ElectroCore LLC

Brief Summary:
Multi-center, prospective, double-blind, randomized, sham-controlled pivotal study of non-invasive vagus nerve stimulation with the GammaCore® device for the acute treatment of cluster headache. The study compares the safety and effectiveness of an active treatment (GammaCore) against a sham treatment.

Condition or disease Intervention/treatment Phase
Cluster Headache Device: GammaCore Device: Sham GammaCore device Not Applicable

Detailed Description:

Phase 1: Prospective, randomized (1:1 active treatment:sham control allocation), double blinded, sham controlled treatment (active or sham) phase

Phase 2: Prospective, non-randomized, active treatment phase.

Phase 1 - Two Arms:

  1. Active Treatment with the GammaCore Device
  2. Sham Treatment with a placebo device

Phase 2 - One Arm:

Active Treatment with the GammaCore Device


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Treatment of Cluster Headache
Study Start Date : February 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Sham GammaCore device
The Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
Device: Sham GammaCore device
Treatment with sham stimulator
Experimental: GammaCore Device
Non-Invasive Vagus Nerve Stimulator
Device: GammaCore
Treatment with active gammacore vagus nerve stimulator



Primary Outcome Measures :
  1. Number of Participants With Repsonse to Treatment [ Time Frame: 15 minutes post stimulation ]

    The primary outcome measurement for effectiveness is the rate of responders for the active treatment group, compared to the sham control group.

    A responder is defined as a subject who has recorded an intensity of 0 or 1 on the 5-point headache pain scale (no pain, mild, moderate, severe, very severe) at 15 minutes post-initiation of treatment of the first treated cluster headache attack of Phase 1.



Secondary Outcome Measures :
  1. Sustained Treatment Success at 1 Hour Post-Treatment [ Time Frame: For 1 hour post stimulation ]
    Sustained treatment success at 1 hour post-treatment was defined as having recorded an intensity of 0 or 1 on the 5-point headache pain scale at 15 minutes and 1 hour post-initiation of treatment of the first treated cluster headache attack of Phase 1, and having refrained from use of rescue medications during the full 60 minute period

  2. Average Mean Attack Intensities Experienced Per Subject [ Time Frame: 15 minutes post-stimulation ]
    Cluster headache attack intensity was reported on a 5-point scale: no pain, mild, moderate, severe, very severe, whereas no pain =1 is the best outcome and very severe=5 is the worst outcome . The average of all subjects' mean attack intensities experienced at 15 minutes post-initiation of treatment during Phase 1 for the active treatment group, compared to the sham control group. The mean 15-minute scores were calculated for the first five attacks suffered by each subject during Phase 1. For subjects with fewer than five treated attacks, the scores for those available were averaged.

  3. Incidence and Occurrence of Serious Adverse Events Related to Active or Sham Study Treatment and / or to Cluster Headache Events. [ Time Frame: 4 weeks, Phase 1 ]
    The primary safety measure for this study is the incidence and occurrence of serious adverse events related to active or sham study treatment and / or to cluster headache events during Phase 1 of the study.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is between the ages of 18 and 75 years.
  2. diagnosed with episodic cluster headache, in accordance with the ICHD-2 Classification criteria (2ndEd):

    o At least 5 attacks fulfilling the following criteria:

    • Severe or very severe unilateral orbital, supraorbital and/or temporal pain lasting 15-180 minutes if untreated
    • Headache is accompanied by at least 1 of the following:
    • Ipsilateral conjunctival injection and/or lacrimation
    • Ipsilateral nasal congestion and/or rhinorrhea
    • Ipsilateral eyelid edema
    • Ipsilateral forehead and facial sweating
    • Ipsilateral miosis and/or ptosis
    • A sense of restlessness or agitation
  3. currently experiencing cluster headaches, and from clinical history is expected to continue experiencing cluster headaches for a period of at least 4 weeks.
  4. able to distinguish CH from other headaches (i.e. migraine, tension-type headaches).
  5. capable of completing headache pain self-assessments.
  6. [Intentionally left blank].
  7. Agrees to use the GammaCore device as intended and follow all of the requirements of the study, including follow-up visit requirements.
  8. Agrees to record usage of the GammaCore device, all required study data, and report any adverse device effects to the study center within 24 hours of any such adverse device effects.
  9. able to provide written Informed Consent

Exclusion Criteria:

  1. had surgery to treat cluster headache.
  2. currently taking prophylactic medication (including chronic opioids and non-prescribed street drugs) for indications other than CH that in the opinion of the clinician may interfere with the study.
  3. [Intentionally left blank].
  4. undergone botulinum toxin injections in the head and/or neck in the last 3 months or nerve blocks (occipital or other) in the head or neck in the last month.
  5. history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
  6. lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the treatment site.
  7. structural intracranial, or cervical vascular lesions that may potentially cause headache attacks.
  8. other significant pain problem (including cancer pain, fibromyalgia, and trigeminal neuralgia/TAC-cluster) that might confound the study assessments.
  9. 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.
  10. history of prolonged QT interval or a history of clinically significant arrhythmia.
  11. abnormal baseline ECG (e.g. second and third degree heart block, atrial fibrillation, atrial flutter, recent history of ventricular tachycardia or ventricular fibrillation, or clinically significant premature ventricular contraction).
  12. previous bilateral or right cervical vagotomy.
  13. uncontrolled high blood pressure.
  14. 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.
  15. history of carotid endarterectomy or vascular neck surgery on the right side.
  16. implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site.
  17. recent or repeated history of syncope.
  18. recent or repeated history of seizure.
  19. known history or suspicion of substance abuse or addiction, or overuse of acute headache medication for headaches other than CH.
  20. psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the clinician may interfere with the study.
  21. pregnant, nursing, thinking of becoming pregnant in the next 4 months, or of childbearing years and is unwilling to use an accepted form of birth control.
  22. participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
  23. Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792817


  Show 20 Study Locations
Sponsors and Collaborators
ElectroCore LLC
Investigators
Study Director: Lia Spitzer ElectroCore LLC

Study Data/Documents: Publication  This link exits the ClinicalTrials.gov site
Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study Stephen D. Silberstein, MD; Laszlo L. Mechtler, MD; David B. Kudrow, MD; Anne H. Calhoun, MD; Candace McClure, PhD; Joel R. Saper, MD; Eric J. Liebler; Emily Rubenstein Engel, MD; Stewart J. Tepper, MD; on Behalf of the ACT1 Study Group

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ElectroCore LLC
ClinicalTrials.gov Identifier: NCT01792817     History of Changes
Other Study ID Numbers: CH-US-01
First Posted: February 15, 2013    Key Record Dates
Results First Posted: May 17, 2018
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by ElectroCore LLC:
Cluster Headache
GammaCore
vagal nerve stimulation
nVNS
VNS
non invasive
vagus nerve stimulation

Additional relevant MeSH terms:
Headache
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases