Brief 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.
Brief Title
Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine
Categories
Completion Date
Completion Date Type
Actual
Conditions
Migraine
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* 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.
* 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
Exclusion Criteria:
* 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.
* 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.
Inclusion Criteria
Inclusion Criteria:
* 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
* 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
Gender
All
Gender Based
false
Keywords
vagus nerve stimulation
vagal nerve stimulation
nVNS
VNS
migraine
non invasive
gammacore
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
55 Years
Minimum Age
18 Years
NCT Id
NCT01532830
Org Class
Industry
Org Full Name
ElectroCore INC
Org Study Id
M-US-01
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device For the Relief of Symptoms Associated With Migraine
Primary Outcomes
Outcome Description
The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.
Outcome Measure
Safety - Number of Participants With Adverse Effects
Outcome Time Frame
End of Study - 7 weeks
Secondary Outcomes
Outcome Description
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
Data presented shows the average change from baseline to 120 minutes
Outcome Time Frame
120 minutes
Outcome Measure
Mean Change in Headache Pain From Baseline to 120 Minutes
Outcome Description
Presence of photophobia (yes or no) was captured at baseline and 120 minutes.
Outcome Time Frame
Base line and 120 minutes
Outcome Measure
Change in Photophobia (Visual) From Baseline to 120 Minutes
Outcome Description
Presence of phonophobia (yes or no) was captured at baseline and 120 minutes.
Outcome Time Frame
Baseline and 120 minutes
Outcome Measure
Change in Phonophobia (Auditory) From Baseline to 120 Minutes
Outcome Description
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.
Outcome Time Frame
Baseline 120 minutes
Outcome Measure
Mean Change in Nausea From Baseline to 120 Minutes
Outcome Description
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.
Outcome Time Frame
Baseline and 120 minutes
Outcome Measure
Mean Change in Functional Disability
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Maximum Age Number (converted to Years and rounded down)
55
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Brian Grosberg
Investigator Email
bgrosber@montefiore.org
Investigator Phone