MigraineNCT01532830
Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine
A study testing n-VNS in people with Migraine, run by ElectroCore INC at 3 sites in United States.
Trial summary
The purpose of this pilot study is to assess feasibility and clarify the design of future study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or prevention of migraine symptoms. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine
- What is being tested?
- n-VNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2012to 25 Jul 2012
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Is between the ages of 18 and 55 years.
- Has been previously diagnosed as suffering from migraine, in accordance with the ICHD-2 Classification criteria (2nd), with or without aura.
- Experiences at least 2 migraines per month, but less than 15 headache days per month (over the last 3 months).
- Has age of onset of migraine less than 50 years old.
- Is able to give written Informed Consent
Who cannot join
- Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
- Has a lesion (including lymphadenopathy) at the GammaCore™ treatment site.
- 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), coronary artery disease or recent myocardial infarction.
- Has a history or baseline ECG that identifies the presence of a clinically significant unstable cardiac arrhythmia, second degree heart block type II, history of ventricular tachycardia or ventricular fibrillation, or known cardiac syndromes that may be associated with increased risk of sudden death in otherwise healthy people.
- Has had a previous bilateral or right cervical vagotomy.
- Has a clinically significant irregular heart rate or rhythm.
Show all 18Show fewer
- Has uncontrolled high blood pressure.
- Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant.
- Has a history of carotid endarterectomy or vascular neck surgery on the right side.
- Has been implanted with metal cervical spine hardware or has a metallic implant near the GammaCore™ stimulation site.
- Has a recent or repeated history of syncope.
- Has a recent or repeated history of seizure.
- Has a history or suspicion of narcotic abuse.
- Takes medication for acute headaches more than 10 days per month.
- Is pregnant, nursing, thinking of becoming pregnant in the next 3 months, or of childbearing years and is unwilling to use an accepted form of birth control.
- Is 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 (e.g., homeless, developmentally disabled, prisoner).
- Is a relative of or an employee of the investigator or the clinical study site.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New York Headache Center
New York, New York, 10021
UCSF Headache Center
San Francisco, California, 94143
Montefiore Headache Center
The Bronx, New York, 10461
About this study
Official title: Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device For the Relief of Symptoms Associated With Migraine
The purpose of this pilot study is to assess feasibility and clarify the design of future study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or prevention of migraine symptoms.
- Conditions
- Migraine
- Being tested
- n-VNS
- Keywords
- vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, migraine, non invasive, gammacore
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-VNSDevice
Also called gammaCore
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | n-VNS active therapy Receives: Device: n-VNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Number of Participants With Adverse Effects
The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.
Measured: End of Study - 7 weeks
Secondary outcomes (5)
Mean Change in Headache Pain From Baseline to 120 Minutes
Headache was measured on a 4 point scale where 0 = no pain, 1 = mild, 2 = moderate, 3 = severe pain at baseline (start of attack), 5, 15, 30, 45, 60, 90 and 120 minutes.
Data presented shows the average change from baseline to 120 minutes
Measured: 120 minutes
Change in Photophobia (Visual) From Baseline to 120 Minutes
Presence of photophobia (yes or no) was captured at baseline and 120 minutes.
Measured: Base line and 120 minutes
Change in Phonophobia (Auditory) From Baseline to 120 Minutes
Presence of phonophobia (yes or no) was captured at baseline and 120 minutes.
Measured: Baseline and 120 minutes
Mean Change in Nausea From Baseline to 120 Minutes
Nausea was captured in the diary and measured on a 4 point scale, where 0 = no nausea, 1 = mild, 2 = moderate and 3 = severe nausea, at baseline and 120 minutes.
Measured: Baseline 120 minutes
Mean Change in Functional Disability
Functional disability was captured in the diary and measured on a 4 point scale, where 0 = no disability, able to function normally and where 3 = performance of daily activities severely impaired, measured at baseline and 120 minutes.
Measured: Baseline and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completion25 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElectroCore INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532830
- Sponsor's protocol ID
- M-US-01
- Status last verified
- Jun 2018
- First submitted
- 10 Feb 2012
- Last updated
- 10 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
Goadsby PJ, Grosberg BM, Mauskop A, Cady R, Simmons KA. Effect of noninvasive vagus nerve stimulation on acute migraine: an open-label pilot study. Cephalalgia. 2014 Oct;34(12):986-93. doi: 10.1177/0333102414524494. Epub 2014 Mar 7.
PubMed 24607501
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device For the Relief of Symptoms Associated With Migraine
- ClinicalTrials.gov ID
- NCT01532830
- Acronym / sponsor ID
- M-US-01
- Conditions
- Migraine
- Keywords
- vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, migraine, non invasive, gammacore
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ElectroCore INCIndustry (pharma, biotech, devices)
- Study start
- Feb 2012 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- 25 Jul 2012 (actual)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Posted 11 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to assess feasibility and clarify the design of future study(ies) to support marketing approval of the GammaCore™ device for the treatment and/or prevention of migraine symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: n-VNSn-VNS active therapy |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Is between the ages of 18 and 55 years.
- Has been previously diagnosed as suffering from migraine, in accordance with the ICHD-2 Classification criteria (2nd), with or without aura.
- Experiences at least 2 migraines per month, but less than 15 headache days per month (over the last 3 months).
- Has age of onset of migraine less than 50 years old.
- Is able to give written Informed Consent
Key exclusion criteria (18 listed)
- Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
- Has a lesion (including lymphadenopathy) at the GammaCore™ treatment site.
- 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), coronary artery disease or recent myocardial infarction.
- Has a history or baseline ECG that identifies the presence of a clinically significant unstable cardiac arrhythmia, second degree heart block type II, history of ventricular tachycardia or ventricular fibrillation, or known cardiac syndromes that may be associated with increased risk of sudden death in otherwise healthy people.
- Has had a previous bilateral or right cervical vagotomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-VNSAlso: gammaCore | Device | Active |
Primary outcome
Safety - Number of Participants With Adverse Effects
Time frame: End of Study - 7 weeks
The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.
5 secondary outcomes
Mean Change in Headache Pain From Baseline to 120 Minutes
Time frame: 120 minutes
Change in Photophobia (Visual) From Baseline to 120 Minutes
Time frame: Base line and 120 minutes
Change in Phonophobia (Auditory) From Baseline to 120 Minutes
Time frame: Baseline and 120 minutes
Mean Change in Nausea From Baseline to 120 Minutes
Time frame: Baseline 120 minutes
Mean Change in Functional Disability
Time frame: Baseline and 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24607501Goadsby PJ, Grosberg BM, Mauskop A, Cady R, Simmons KA. Effect of noninvasive vagus nerve stimulation on acute migraine: an open-label pilot study. Cephalalgia. 2014 Oct;34(12):986-93. doi: 10.1177/0333102414524494. Epub 2014 Mar 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-VNS in people with Migraine, run by ElectroCore INC at 3 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 5 inclusion and 18 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 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 11 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?
Safety - Number of Participants With Adverse Effects (time frame: End of Study - 7 weeks). 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 NCT01532830, which also lists 1 linked publication.
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 10 Jul 2018.