MigraineNCT03410628
Non-invasive Neurostimulation for the Relief of Migraine
A study testing gammaCore in people with Migraine, run by ElectroCore INC.
Trial summary
The purpose of this feasibility study is to gather preliminary information on the safety and effectiveness of patient self-administration of a noninvasive neurostimulation of the vagus nerve using the GammaCore device for the treatment of pain and allodynia symptoms associated with acute migraine in adults. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine
- What is being tested?
- gammaCore
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Dec 2011
- 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 IHS-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 distinguish migraines from other headaches (e.g. tension headache).
- Agrees to withhold usual migraine medications until after stimulation treatment with the GammaCore device.
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- Agrees to follow all of the requirements of the study, including follow-up visit requirements, and is sufficiently trained with respect to the operation of the GammaCore device and the data collection procedures.
- Agrees to report use of the GammaCore device, study data, and any adverse device effects to the study center within 24 hours of treatment(s), and agrees to schedule an office visit 4-10 days after the third and final treatment, or when 6 weeks has passed, whichever comes first.
- Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent.
Who cannot join
- Has a history of aneurysm, bleed, brain tumors or significant head trauma.
- Has a lesion (including lymphadenopathy) at the therapy head placement site.
- Has known or suspected severe atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF).
- Has a history of epilepsy.
- Has suspected or confirmed sepsis, or infection.
- Has a clinically significant irregular heart rate or rhythm.
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- Is receiving pressors to maintain blood pressure.
- Has a history of syncope.
- 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 been implanted with metal cervical spine hardware.
- Has a history of carotid endarterectomy or vascular neck surgery on the right side.
- Has a condition that would interfere with headache pain self-assessment.
- Is pregnant or is thinking of becoming pregnant in the next 6 weeks.
- Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
- Takes medication for acute headaches more than 10 days per month.
- Has a history or suspicion of substance abuse
- 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).
About this study
Official title: Non-invasive Neurostimulation of the Vagus Nerve With the gammaCore Device for the Relief of Pain and Allodynia Associated With Migraine
The purpose of this feasibility study is to gather preliminary information on the safety and effectiveness of patient self-administration of a noninvasive neurostimulation of the vagus nerve using the GammaCore device for the treatment of pain and allodynia symptoms associated with acute migraine in adults.
Read the detailed description
This is a prospective, non-randomized, unblinded, multi-center feasibility study; 25 subjects will be enrolled at up to 5 study centers. Subjects considered for participation in this study will be those who have a diagnosis and documented history at least 2 episodes of acute headache pain and allodynia associated with migraine per month, but no more than 15 headache days per month. Subjects may, but are not required to experience prodromal symptoms, such as aura, or concomitant photophobia, phonophobia, or nausea with their migraine episodes, so long as their headaches meet the IHS-Classification criteria for migraine. Subjects will be screened for study eligibility and consented for study participation at presentation to the headache clinic. Once consented, subjects will be trained by the Investigator(s) at the study center on at-home use of the GammaCore device and on study data collection and other requirements.
Each subject enrolled in this study will treat up to 3 migraine headaches at home over a period of up to 6 weeks.
From the onset of headache pain, the subject will withhold usual migraine medications and wait until the pain becomes moderate or severe, or 30 minutes, whichever is sooner. At that point, the subject will self-administer a first stimulation treatment, which is 90 seconds in duration.
- Conditions
- Migraine
- Being tested
- 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.
gammaCoreDevice
Non-invasive vagal nerve stimulator
| Study group | Role | What they receive |
|---|---|---|
| gammaCore Active Device | Experimental | open label Receives: Device: gammaCore |
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 events for the duration of the study
Measured: Up to 4 months
Secondary outcomes (1)
Change in Headache Pain Severity From Baseline to 120 Minutes for First Treated Migraine Attack
At the onset of headache pain subjects self-administered treatment with the study device and completed headache pain scores using a 4 point scale (where 3 = severe, 2 = moderate, 1 = mild and 0 = no pain) at baseline (0 minutes) and 120 minutes.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study startJul 2011
- Primary completionAug 2011
- Study completionDec 2011
Why it stopped: Company decision
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.
- 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
- 21 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
- NCT03410628
- Sponsor's protocol ID
- M-SA-01
- Status last verified
- Jul 2018
- First submitted
- 12 Mar 2015
- Last updated
- 26 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 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 Pain and Allodynia Associated With Migraine
- ClinicalTrials.gov ID
- NCT03410628
- Acronym / sponsor ID
- M-SA-01
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision
- Enrolment
- 21 participants (actual)
- Lead sponsor
- ElectroCore INCIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Posted 26 Jul 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 feasibility study is to gather preliminary information on the safety and effectiveness of patient self-administration of a noninvasive neurostimulation of the vagus nerve using the GammaCore device for the treatment of pain and allodynia symptoms associated with acute migraine in adults.
Detailed description
This is a prospective, non-randomized, unblinded, multi-center feasibility study; 25 subjects will be enrolled at up to 5 study centers. Subjects considered for participation in this study will be those who have a diagnosis and documented history at least 2 episodes of acute headache pain and allodynia associated with migraine per month, but no more than 15 headache days per month. Subjects may, but are not required to experience prodromal symptoms, such as aura, or concomitant photophobia, phonophobia, or nausea with their migraine episodes, so long as their headaches meet the IHS-Classification criteria for migraine. Subjects will be screened for study eligibility and consented for study participation at presentation to the headache clinic. Once consented, subjects will be trained by the Investigator(s) at the study center on at-home use of the GammaCore device and on study data collection and other requirements.
Each subject enrolled in this study will treat up to 3 migraine headaches at home over a period of up to 6 weeks.
From the onset of headache pain, the subject will withhold usual migraine medications and wait until the pain becomes moderate or severe, or 30 minutes, whichever is sooner. At that point, the subject will self-administer a first stimulation treatment, which is 90 seconds in duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gammaCore Active Device | Experimental | Device: gammaCoreopen label |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Is between the ages of 18 and 55 years.
- Has been previously diagnosed as suffering from migraine, in accordance with the IHS-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 distinguish migraines from other headaches (e.g. tension headache).
Key exclusion criteria (17 listed)
- Has a history of aneurysm, bleed, brain tumors or significant head trauma.
- Has a lesion (including lymphadenopathy) at the therapy head placement site.
- Has known or suspected severe atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF).
- Has a history of epilepsy.
- Has suspected or confirmed sepsis, or infection.
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 |
|---|---|---|
| gammaCoreNon-invasive vagal nerve stimulator | Device | gammaCore Active Device |
Primary outcome
Safety - Number of Participants With Adverse Events
Time frame: Up to 4 months
Safety was assessed by collecting adverse events for the duration of the study
1 secondary outcome
Change in Headache Pain Severity From Baseline to 120 Minutes for First Treated Migraine Attack
Time frame: 120 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing gammaCore in people with Migraine, run by ElectroCore INC.
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 9 inclusion and 17 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: stopped early, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 26 Jul 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 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2018.