Brief 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 migraine, and to support the development and approval of a larger pivotal study.
Brief Title
Non-Invasive Neurostimulation for the Prevention of Chronic Migraine
Categories
Completion Date
Completion Date Type
Actual
Conditions
Chronic Migraine
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* 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.
* 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
Exclusion Criteria:
* 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.
* 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.
Inclusion Criteria
Inclusion Criteria:
* 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
* 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
Gender
All
Gender Based
false
Keywords
vagus nerve stimulation
vagal nerve stimulation
nVNS
VNS
chronic migraine
migraine
non invasive
gammacore
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
18 Years
NCT Id
NCT01667250
Org Class
Industry
Org Full Name
ElectroCore INC
Org Study Id
M-US-02
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 Prevention of Chronic Migraine
Primary Outcomes
Outcome Description
Safety was assessed by collecting Adverse Effects
Outcome Measure
Safety - Number of Participants With Adverse Events
Outcome Time Frame
Up to 8 weeks - duration of the Randomized period
Secondary Outcomes
Outcome Description
Mean change in headache days. Change between 4 week run in period to the 8 weeks randomized period.
Outcome Time Frame
Run-in period (4 weeks no treatment) and Randomized period (8 weeks)
Outcome Measure
Mean Change in Headache Days
Outcome Description
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.
Outcome Time Frame
Run-in (4 weeks no treatment) and Randomized (8 weeks)
Outcome Measure
Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe
Outcome Description
All abortive headache medication taken during randomized period
Outcome Time Frame
Randomized period - 8 weeks
Outcome Measure
Use of Pain Relief Medication
Outcome Description
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.
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.
Outcome Time Frame
Run-in (4 weeks) and Randomized period (8 weeks)
Outcome Measure
Mean Change in Quality of Life Short Form Survey (SF-12)
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
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