Back to resultsNon-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
n-VNS
Sponsored by
About this trial
This is an interventional treatment trial for Migraine focused on measuring vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, migraine, non invasive, gammacore
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.
Sites / Locations
- UCSF Headache Center
- Montefiore Headache Center
- New York Headache Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active
Arm Description
n-VNS active therapy
Outcomes
Primary Outcome Measures
Safety - Number of Participants With Adverse Effects
The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.
Secondary Outcome Measures
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
Change in Photophobia (Visual) From Baseline to 120 Minutes
Presence of photophobia (yes or no) was captured at baseline 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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01532830
Brief Title
Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine
Official Title
Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device For the Relief of Symptoms Associated With Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 25, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ElectroCore INC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, migraine, non invasive, gammacore
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
n-VNS active therapy
Intervention Type
Device
Intervention Name(s)
n-VNS
Other Intervention Name(s)
gammaCore
Primary Outcome Measure Information:
Title
Safety - Number of Participants With Adverse Effects
Description
The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.
Time Frame
End of Study - 7 weeks
Secondary Outcome Measure Information:
Title
Mean Change in Headache Pain From Baseline to 120 Minutes
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
Time Frame
120 minutes
Title
Change in Photophobia (Visual) From Baseline to 120 Minutes
Description
Presence of photophobia (yes or no) was captured at baseline and 120 minutes.
Time Frame
Base line and 120 minutes
Title
Change in Phonophobia (Auditory) From Baseline to 120 Minutes
Description
Presence of phonophobia (yes or no) was captured at baseline and 120 minutes.
Time Frame
Baseline and 120 minutes
Title
Mean Change in Nausea From Baseline to 120 Minutes
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.
Time Frame
Baseline 120 minutes
Title
Mean Change in Functional Disability
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.
Time Frame
Baseline and 120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
UCSF Headache Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Montefiore Headache Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
New York Headache Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24607501
Citation
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.
Results Reference
result
Learn more about this trial
Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine
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