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Cluster HeadacheCHNCT01792817

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

A study testing GammaCore in people with Cluster Headache, run by ElectroCore INC at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cluster Headache
What is being tested?
GammaCore
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
20 sitesUnited States
Study dates
Feb 2013to Oct 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Is between the ages of 18 and 75 years.
  • Has been diagnosed with 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:
Show all 19Show fewer
  • 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
  • currently experiencing cluster headaches, and from clinical history is expected to continue experiencing cluster headaches for a period of at least 4 weeks.
  • able to distinguish CH from other headaches (i.e. migraine, tension-type headaches).
  • capable of completing headache pain self-assessments.
  • [Intentionally left blank].
  • Agrees to use the GammaCore device as intended and follow all of the requirements of the study, including follow-up visit requirements.
  • 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.
  • able to provide written Informed Consent

Who cannot join

  • had surgery to treat cluster headache.
  • 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.
  • [Intentionally left blank].
  • 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.
  • history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
  • lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy at the treatment site.
Show all 23Show fewer
  • structural intracranial, or cervical vascular lesions that may potentially cause headache attacks.
  • other significant pain problem (including cancer pain, fibromyalgia, and trigeminal neuralgia/TAC-cluster) that might confound the study assessments.
  • 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.
  • history of prolonged QT interval or a history of clinically significant arrhythmia.
  • 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).
  • previous bilateral or right cervical vagotomy.
  • uncontrolled high blood pressure.
  • 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.
  • history of carotid endarterectomy or vascular neck surgery on the right side.
  • implanted with metal cervical spine hardware or has a metallic implant near the GammaCore stimulation site.
  • recent or repeated history of syncope.
  • recent or repeated history of seizure.
  • known history or suspicion of substance abuse or addiction, or overuse of acute headache medication for headaches other than CH.
  • psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the clinician may interfere with the study.
  • 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.
  • participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Michigan Head Pain & Neurological Institute

    Ann Arbor, Michigan, 48104

  • Carolina Headache Institute

    Chapel Hill, North Carolina, 27516

  • Diamond Headache Clinic

    Chicago, Illinois, 60642

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Colorado Neurological Institute

    Englewood, Colorado, 80113

  • Associated Neurologists of Southern Connecticut

    Fairfield, Connecticut, 06824

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242

  • Norton Neurology

    Louisville, Kentucky, 40207

  • West Virginia University Dept of Neurology

    Morgantown, West Virginia, 26506

  • Montefiore Headache Center

    New York, New York, 10461

  • Jefferson Headache Center

    Philadelphia, Pennsylvania, 19107

  • Mid-Atlantic Headache Institute

    Pikesville, Maryland, 21208

  • Center for Headache Care and Research at Island Neurological Associates, PC

    Plainview, New York, 11803

  • California Medical Clinic for Headache

    Santa Monica, California, 90404

  • Headache Care Center

    Springfield, Missouri, 65807

  • Stanford University Medical Center

    Stanford, California, 94305

  • Tampa General Hospital Headache Center

    Tampa, Florida, 33606

  • New England Regional Headache Center

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: Non-invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Treatment of Cluster Headache

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.

Read the 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

Being tested
GammaCore, Sham GammaCore device
Keywords
Cluster Headache, GammaCore, vagal nerve stimulation, nVNS, VNS, non invasive, vagus nerve stimulation
Medical subject headings
Cluster Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GammaCoreDevice

    Treatment with active gammacore vagus nerve stimulator

  • Sham GammaCore deviceDevice

    Treatment with sham stimulator

Study groups in NCT01792817
Study groupRoleWhat they receive
Sham GammaCore deviceSham comparatorThe Sham GammaCore device looks and operates like the Active GammaCore device, but does not deliver a therapeutic stimulation treatment.
Receives: Device: Sham GammaCore device
GammaCore DeviceExperimentalNon-Invasive Vagus Nerve Stimulator
Receives: Device: GammaCore

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Repsonse to Treatment

    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.

    Measured: 15 minutes post stimulation

Secondary outcomes (3)

  1. Sustained Treatment Success at 1 Hour Post-Treatment

    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

    Measured: For 1 hour post stimulation

  2. Average Mean Attack Intensities Experienced Per Subject

    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.

    Measured: 15 minutes post-stimulation

  3. Incidence and Occurrence of Serious Adverse Events Related to Active or Sham Study Treatment and / or to Cluster Headache Events.

    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.

    Measured: 4 weeks, Phase 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionJun 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01792817
Sponsor's protocol ID
CH-US-01
Acronym
CH
Status last verified
Dec 2019
First submitted
8 Feb 2013
Last updated
17 Dec 2019
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • de Coo IF, Marin JC, Silberstein SD, Friedman DI, Gaul C, McClure CK, Tyagi A, Liebler E, Tepper SJ, Ferrari MD, Goadsby PJ. Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis. Cephalalgia. 2019 Jul;39(8):967-977. doi: 10.1177/0333102419856607. Epub 2019 Jun 10.

    PubMed 31246132

  • Silberstein SD, Mechtler LL, Kudrow DB, Calhoun AH, McClure C, Saper JR, Liebler EJ, Rubenstein Engel E, Tepper SJ; ACT1 Study Group. Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study. Headache. 2016 Sep;56(8):1317-32. doi: 10.1111/head.12896.

    PubMed 27593728

Questions about this trial

What is this clinical trial studying?

A study testing GammaCore in people with Cluster Headache, run by ElectroCore INC at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Repsonse to Treatment (time frame: 15 minutes post stimulation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01792817, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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