Chronic MigraineNCT01667250
Non-Invasive Neurostimulation for the Prevention of Chronic Migraine
A study testing GammaCore Active Device in people with Chronic Migraine, run by ElectroCore INC at 6 sites in United States.
Trial summary
The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect preliminary clinical data related to the safety and clinical benefits of daily use of non-invasive vagal nerve stimulation with the GammaCore device for the prevention of chronic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- GammaCore Active Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2012to May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is between the ages of 18 and 65 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 15 headache days per month (over the last 3 months).
- Has age of onset of migraine less than 50 years old.
- Agrees not to use any migraine prevention treatments (including Botox injections) and/or medications (exclusive of medications taken for acute relief of migraine symptoms).
- Is able to provide written Informed Consent
- Agrees to refrain from changing the type or dosage of any prophylactic medications for indications other than chronic migraine that in the opinion of the clinician may interfere with the study
Who cannot join
- Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
- Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy 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), known severe coronary artery disease or recent myocardial infarction.
- Has an 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)
- Has had a previous bilateral, right, or left cervical vagotomy.
- Has uncontrolled high blood pressure.
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- Is 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.
- 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 known history or suspicion of substance abuse or addiction.
- Has had a surgery for migraine prevention.
- Has received Botox injections for migraine prevention within the past 6 months.
- Has taken medications for migraine prophylaxis in the previous 30 days.
- In the opinion of the investigator/research staff the subject is incapable of operating the GammaCore device as intended and performing the data collection procedures.
- Is pregnant, nursing, thinking of becoming pregnant in the next 9 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, 48104
Carolina Headache Institute
Chapel Hill, North Carolina, 27516
Thomas Jefferson Headache Center
Philadelphia, Pennsylvania, 19107
UCSF Headache Center
San Francisco, California, 94143
Headache Care Center
Springfield, Missouri, 65807
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 Prevention of Chronic Migraine
The purpose of this multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect preliminary clinical data related to the safety and clinical benefits of daily use of non-invasive vagal nerve stimulation with the GammaCore device for the prevention of chronic migraine, and to support the development and approval of a larger pivotal study.
- Conditions
- Chronic Migraine
- Being tested
- GammaCore Active Device, GammaCore Sham Device
- Keywords
- vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, chronic migraine, 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.
GammaCore Active DeviceDevice
GammaCore Sham DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| GammaCore Active Device | Active comparator | Subjects will use an Active GammaCore Device Receives: Device: GammaCore Active Device |
| GammaCore Sham Device | Sham comparator | Subjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study. Receives: Device: GammaCore Active Device; Device: GammaCore Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Number of Participants With Adverse Events
Safety was assessed by collecting Adverse Effects
Measured: Up to 8 weeks - duration of the Randomized period
Secondary outcomes (4)
Mean Change in Headache Days
Mean change in headache days. Change between 4 week run in period to the 8 weeks randomized period.
Measured: Run-in period (4 weeks no treatment) and Randomized period (8 weeks)
Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe
Peak severity per headache day was reported each headache day in the subject diary. Pain was reported as mild, moderate or severe. Whereas as mild = least severe and severe = most severe.
Measured: Run-in (4 weeks no treatment) and Randomized (8 weeks)
Use of Pain Relief Medication
All abortive headache medication taken during randomized period
Measured: Randomized period - 8 weeks
Mean Change in Quality of Life Short Form Survey (SF-12)
The Quality of Life Short Form Survey (SF-12) is a multipurpose short form survey with 12 questions that are combined, scored and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. The SF-12 is weighted and summed to provide easily interpretable scales for physical and mental health. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
SF-12 were recorded in the subject diary at the Phase 1 follow-up visit (week 4) and during Phase 2 randomized period at week 4 and week 8.
Measured: Run-in (4 weeks) and Randomized period (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionMay 2014
- Study completionMay 2014
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 Chronic 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 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
- NCT01667250
- Sponsor's protocol ID
- M-US-02
- Status last verified
- May 2018
- First submitted
- 15 Aug 2012
- Last updated
- 20 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Silberstein SD, Calhoun AH, Lipton RB, Grosberg BM, Cady RK, Dorlas S, Simmons KA, Mullin C, Liebler EJ, Goadsby PJ, Saper JR; EVENT Study Group. Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study. Neurology. 2016 Aug 2;87(5):529-38. doi: 10.1212/WNL.0000000000002918. Epub 2016 Jul 13.
PubMed 27412146
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 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 Prevention of Chronic Migraine
- ClinicalTrials.gov ID
- NCT01667250
- Acronym / sponsor ID
- M-US-02
- Conditions
- Chronic Migraine
- Keywords
- vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, chronic migraine, migraine, non invasive, gammacore
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- ElectroCore INCIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Posted 20 Jun 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 multi-center, prospective, double-blind, randomized, sham-controlled pilot study is to study feasibility and collect preliminary clinical data related to the safety and clinical benefits of daily use of non-invasive vagal nerve stimulation with the GammaCore device for the prevention of chronic migraine, and to support the development and approval of a larger pivotal study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GammaCore Active Device | Active comparator | Device: GammaCore Active DeviceSubjects will use an Active GammaCore Device |
| GammaCore Sham Device | Sham comparator | Device: GammaCore Active Device, Device: GammaCore Sham DeviceSubjects who treat with the gammacore sham device in Phase 2 will receive the active gammacore treatment during phase 3 (active treatment) of this study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is between the ages of 18 and 65 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 15 headache days per month (over the last 3 months).
- Has age of onset of migraine less than 50 years old.
- Agrees not to use any migraine prevention treatments (including Botox injections) and/or medications (exclusive of medications taken for acute relief of migraine symptoms).
Key exclusion criteria (20 listed)
- Has a history of aneurysm, intracranial hemorrhage, brain tumors or significant head trauma.
- Has a lesion (including lymphadenopathy), dysaesthesia, previous surgery or abnormal anatomy 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), known severe coronary artery disease or recent myocardial infarction.
- Has an 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)
- Has had a previous bilateral, right, or left 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 |
|---|---|---|
| GammaCore Active Device | Device | GammaCore Active Device, GammaCore Sham Device |
| GammaCore Sham Device | Device | GammaCore Sham Device |
Primary outcome
Safety - Number of Participants With Adverse Events
Time frame: Up to 8 weeks - duration of the Randomized period
Safety was assessed by collecting Adverse Effects
4 secondary outcomes
Mean Change in Headache Days
Time frame: Run-in period (4 weeks no treatment) and Randomized period (8 weeks)
Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe
Time frame: Run-in (4 weeks no treatment) and Randomized (8 weeks)
Use of Pain Relief Medication
Time frame: Randomized period - 8 weeks
Mean Change in Quality of Life Short Form Survey (SF-12)
Time frame: Run-in (4 weeks) and Randomized period (8 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27412146Silberstein SD, Calhoun AH, Lipton RB, Grosberg BM, Cady RK, Dorlas S, Simmons KA, Mullin C, Liebler EJ, Goadsby PJ, Saper JR; EVENT Study Group. Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study. Neurology. 2016 Aug 2;87(5):529-38. doi: 10.1212/WNL.0000000000002918. Epub 2016 Jul 13.
- Effect of noninvasive vagus nerve stimulation on acute migraine: An open-label pilot studyLink provided by the sponsor.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GammaCore Active Device in people with Chronic Migraine, run by ElectroCore INC at 6 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 7 inclusion and 20 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 20 Jun 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 Events (time frame: Up to 8 weeks - duration of the Randomized period). 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 NCT01667250, 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 20 Jun 2018.