Back to resultsNon-invasive Neurostimulation for the Relief of Migraine
Primary Purpose
Migraine
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gammaCore
Sponsored by
About this trial
This is an interventional treatment trial for 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 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.
- 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.
Exclusion Criteria:
- 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.
- 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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gammaCore Active Device
Arm Description
open label
Outcomes
Primary Outcome Measures
Safety - Number of Participants With Adverse Events
Safety was assessed by collecting adverse events for the duration of the study
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03410628
Brief Title
Non-invasive Neurostimulation for the Relief of Migraine
Official Title
Non-invasive Neurostimulation of the Vagus Nerve With the gammaCore Device for the Relief of Pain and Allodynia Associated With Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Company decision
Study Start Date
July 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ElectroCore INC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gammaCore Active Device
Arm Type
Experimental
Arm Description
open label
Intervention Type
Device
Intervention Name(s)
gammaCore
Intervention Description
Non-invasive vagal nerve stimulator
Primary Outcome Measure Information:
Title
Safety - Number of Participants With Adverse Events
Description
Safety was assessed by collecting adverse events for the duration of the study
Time Frame
Up to 4 months
Secondary Outcome Measure Information:
Title
Change in Headache Pain Severity From Baseline to 120 Minutes for First Treated Migraine Attack
Description
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.
Time Frame
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 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.
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.
Exclusion Criteria:
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.
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).
12. IPD Sharing Statement
Learn more about this trial
Non-invasive Neurostimulation for the Relief of Migraine
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