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RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks

This study is currently recruiting participants.
Verified November 2016 by ElectroCore LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02686034
First Posted: February 19, 2016
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
ElectroCore LLC
  Purpose
This study is a prospective, multi-centre, randomised, double-blind, sham-controlled investigation designed for comparison of two parallel treatment groups: gammaCore (active nVNS treatment) and a Sham device (control treatment), for the acute treatment of migraine attacks

Condition Intervention
Migraine Device: gammaCore-S Device: gammaCore-S Sham

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-centre, Randomized, Double-blind, Sham-controlled Study of gammaCore® Non-invasive Vagus Nerve Stimulator (nVNS), for the Acute Treatment of Migraine

Resource links provided by NLM:


Further study details as provided by ElectroCore LLC:

Primary Outcome Measures:
  • Treatment Response - No Pain [ Time Frame: 2 hours post-treatment ]
    The primary objective is to compare the treatment response for nVNS and Sham therapies at two hours post-treatment, for the first treated migraine attack during study Period 2. Treatment response is defined as no pain at 2 hours post-treatment.


Secondary Outcome Measures:
  • Nausea/Vomiting [ Time Frame: 2 hours post-treatment ]
    • Presence or absence of nausea/vomiting, photophobia and phonophobia (baseline pre-treatment vs 2-hours post-treatment) for nVNS and sham therapies for the first migraine attack treated during study Period 2.

  • Treatment Response - No Pain or Mild Pain [ Time Frame: 2 hours post-treatment ]
    • Response of no pain or mild pain on the 4-point headache pain scale for the nVNS and sham therapies at 2 hours post-treatment for the first migraine attack treated during study Period 2.

  • Sustained Treatment Response [ Time Frame: 24 and 48 hours post-treatment ]
    • Sustained treatment response at 24 and 48 hours post-treatment for nVNS and sham therapies for the first attack treated during study Period 2. Sustained treatment response is defined as achievement of treatment response and no subsequent increase on the 4 point headache pain scale. A new migraine attack is defined as an attack starting more than 48 hours after relief of the prior migraine attack.


Estimated Enrollment: 300
Study Start Date: January 2016
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: gammaCore-S
Treatment of up to 5 migraine attacks with the Active gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve
Device: gammaCore-S
At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication.
Other Name: nVNS
Sham Comparator: gammaCore-S Sham
Treatment of up to 5 migraine attacks with the Sham gammaCore-S non-invasive vagus nerve stimulator device which delivers a mild electrical signal in the vicinity of the vagus nerve
Device: gammaCore-S Sham
At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication.
Other Name: sham nVNS

Detailed Description:

Period 1: 4-week observational run-in period; no stimulation treatment. Subjects use standard of care (SoC) medication to treat their migraine attacks, according to their individual prescriptions.

Period 2: 4-week randomized/controlled period. After the run-in period, subjects are randomized (1:1) to receive either an nVNS device or a sham device to treat up to 5 migraine attacks.

Period 3: 4-week open-label (active treatment) period. After the randomized period, subjects continue to the open-label period where all subjects receive an active gammaCore device to treat up to 5 migraine attacks.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 18-75 years old.
  2. Has been previously diagnosed with migraine (with or without aura) in accordance with the ICHD-3 Beta classification criteria.
  3. Age of onset of migraines < 50 years old.
  4. Experiences between 3-8 migraine attacks per month of moderate or severe intensity, and less than 15 headache days per month over the last 6 months.
  5. Is able to distinguish migraine headaches from other headaches (e.g. tension type headache).
  6. Agrees to withhold usual acute migraine medications until 2 hours after stimulation treatment with the study device.
  7. Agrees not to initiate new or change existing migraine prophylaxis medication for the duration of the study, or receive nerve blocks or injections.
  8. Agrees not to initiate new or change existing prophylactic medication for indications other than migraine that in the opinion of the Investigator may interfere with the study objectives (e.g. antidepressant, anti-convulsant, beta blockers, etc).
  9. Has internet/web access for web-based e-Diary completion.
  10. Agrees to use the study device as intended, comply with all study requirements including treatment, follow-up visits, record required study data in the subject diary, and complete study self-assessment questionnaires.
  11. Is able to provide written informed consent.

Exclusion Criteria:

  1. Experiences ≥ 15 headache days per month, including migraine, tension type headache, medication overuse headache, and other types of headache as defined in the ICHD-3 Beta classification.
  2. Has a known history or suspicion of secondary headache.
  3. Has previous diagnosis of medication overuse headache (MoH), which has reverted to episodic migraine within the last 6 months.
  4. Has had surgical intervention for migraine prevention.
  5. Has had a cervical vagotomy.
  6. Has a structural abnormality (e.g. lymphadenopathy, neoplasm, previous surgery or abnormal anatomy), or pain (e.g. dysesthesia, neuralgia and/or cervicalgia) at the stimulation treatment site.
  7. Has other significant pain problem (e.g. cancer pain, fibromyalgia or other head or facial disorder) that in the opinion of the Investigator may confound the study assessments.
  8. Is currently implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, cochlear implant, sphenopalatine ganglion stimulator, or occipital nerve stimulator).
  9. Has been implanted with metal cervical spine hardware or has a metallic implant near the stimulation treatment site.
  10. Has failed an adequate trial (two months or greater) of at least 3 classes of a drug therapy for acute treatment of migraine.
  11. Has initiated new, or changed existing medications for migraine prophylaxis in the previous 2 months.
  12. Is using marijuana (including medical marijuana) for any indications, more than twice a month.
  13. Currently takes simple analgesics or non-steroidal anti-inflammatory drugs (NSAIDS) greater than 15 days per month, or triptans, ergots or combined analgesics greater than 10 days per month.
  14. Currently takes opioids greater than 2 days per month for headache relief or body pain.
  15. Has undergone nerve block (occipital or other) in the head or neck within the last 2 months, or Botox injections within the last 6 months.
  16. Has a concomitant medical condition that will require oral or injectable steroids during the study.
  17. Has a history of intracranial aneurysm, intracranial haemorrhage, brain tumour or significant head trauma.
  18. Has known or suspected severe cardiac disease (e.g. symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure(CHF), cerebrovascular disease (e.g. prior stroke or transient ischemic attack symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery), or uncontrolled high blood pressure (systolic >160, diastolic >100 after 3 repeated measurements within 24 hours).
  19. Has a history of syncope or seizure (within the last 5 years).
  20. Has a known history or suspicion of substance abuse or addiction (within the last 5 years).
  21. Has psychiatric or cognitive disorder and/or behavioural problems which in the opinion of the clinician may interfere with the study.
  22. Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled, prisoner).
  23. Is pregnant or thinking of becoming pregnant during the study period, or of childbearing years and is unwilling to use an accepted form of birth control.
  24. Is a relative or employee of the Investigator or the clinical study site.
  25. Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
  26. Has previously used the gammaCore device.
  Contacts and Locations
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): NCT02686034


Contacts
Contact: Cristina Tassorelli, MD, PhD +39 333 171 2990 cristina.tassorelli@mondino.it

Locations
Italy
University Aldo Moro, Ospedale Pediatrico Not yet recruiting
Bari, Italy
Contact: Marina De Tommaso, MD, PhD         
IRCCS Istituto delle Scienze Neurologiche di Bologna, Ospedale Bellaria Recruiting
Bologna, Italy
Contact: Pietro Cortelli, MD, PhD         
University Hospital of Careggi Not yet recruiting
Florence, Italy
Contact: Pierangelo Geppetti, MD, PhD         
Fondazione IRCCS Istituto Neurologico C. Besta Recruiting
Milan, Italy
Contact: Licia Grazzi, MD         
IRCSS "National Neurological Institute C. Mondino" Foundation Recruiting
Pavia, Italy
Contact: Cristina Tassorelli, MD, PhD         
S. Maria della Misericordia Hospital Recruiting
Perugia, Italy
Contact: Paola Sarchielli, MD, PhD         
INM Neuromed IRCCS Recruiting
Pozzilli, Italy
Contact: Anna Ambrosini, MD, PhD         
IRCCS San Raffaele Pisana Recruiting
Rome, Italy
Contact: Piero Barbanti, MD, PhD         
Sant'Andrea Hospital, Sapienza University of Rome Not yet recruiting
Rome, Italy
Contact: Paolo Martelletti, MD, PhD         
University of Turin Not yet recruiting
Turin, Italy
Contact: Innocenzo Rainero, MD, PhD         
Sponsors and Collaborators
ElectroCore LLC
Investigators
Study Chair: Cristina Tassorelli, MD, PhD IRCSS "National Neurological Institute C. Mondino" Foundation
  More Information

Responsible Party: ElectroCore LLC
ClinicalTrials.gov Identifier: NCT02686034     History of Changes
Other Study ID Numbers: GM-16
First Submitted: February 15, 2016
First Posted: February 19, 2016
Last Update Posted: October 12, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ElectroCore LLC:
Migraine
Non-invasive vagus nerve stimulation
Vagus nerve stimulation
Vagal nerve stimulation
gammaCore
episodic migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases