Non-Invasive Neurostimulation For the Relief of Symptoms Associated With Migraine

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Device: n-VNS

• Registration Number: NCT01532830
• Lead Sponsor: ElectroCore INC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-15
• Primary Completion: 2012-07
• Study Completion: 2012-07-25
• Disposition First Submitted: 2016-02-23
• Disposition First Submitted QC: 2018-03-05
• Disposition First Posted: 2018-03-06
• Results First Submitted: 2018-03-07
• Results First Submitted QC: 2018-04-10
• Results First Posted: 2018-05-11
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active	n-VNS	n-VNS active therapy

Primary Outcome Measures

Name	Time	Method
Safety - Number of Participants With Adverse Effects	End of Study - 7 weeks	The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.

Secondary Outcome Measures

Name	Time	Method
Change in Photophobia (Visual) From Baseline to 120 Minutes	Base line and 120 minutes	Presence of photophobia (yes or no) was captured at baseline and 120 minutes.
Change in Phonophobia (Auditory) From Baseline to 120 Minutes	Baseline and 120 minutes	Presence of phonophobia (yes or no) was captured at baseline and 120 minutes.
Mean Change in Headache Pain From Baseline to 120 Minutes	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
Mean Change in Nausea From Baseline to 120 Minutes	Baseline 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	Baseline and 120 minutes	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.

Trial Locations

Locations (3)

UCSF Headache Center; 🇺🇸 San Francisco, California, United States

Montefiore Headache Center; 🇺🇸 Bronx, New York, United States

New York Headache Center; 🇺🇸 New York, New York, United States