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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ElectroCore LLC
ClinicalTrials.gov Identifier:
NCT01792817
First received: February 8, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention
Cluster Headache
Device: GammaCore
Device: Sham GammaCore device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by ElectroCore LLC:

Primary Outcome Measures:
  • Headache pain intensity [ Time Frame: 15 minutes post stimulation ] [ Designated as safety issue: No ]
    The primary outcome measurement for effectiveness is the rate of responders for the active treatment group, compared to the sham control group.


Secondary Outcome Measures:
  • Sustained headache intensity pain [ Time Frame: For 1 hour post stimulation ] [ Designated as safety issue: No ]
    Sustained treatment success at 1 hour post-treatment.

  • Average mean attack intensities experienced per subject [ Time Frame: 15 minutes post-stimulation ] [ Designated as safety issue: No ]
    • 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.

  • Incidence and occurrence of serious adverse events related to active or sham study treatment and / or to cluster headache events. [ Time Frame: Duration Phase 1 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 150
Study Start Date: February 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: GammaCore Device
Non-Invasive Vagus Nerve Stimulator
Device: GammaCore

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01792817

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

No publications provided

Responsible Party: ElectroCore LLC
ClinicalTrials.gov Identifier: NCT01792817     History of Changes
Other Study ID Numbers: CH-US-01
Study First Received: February 8, 2013
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 20, 2014