Non-Invasive Neurostimulation for the Prevention of Chronic Migraine

Chronic Migraine Clinical Trial

Official title:

Non-Invasive Neurostimulation of the Vagus Nerve With the GammaCore Device for the Prevention of Chronic Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667250
• Other study ID #: M-US-02
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2018
• Source: ElectroCore LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Device:
• GammaCore Active Device

• GammaCore Sham Device

Locations

Country	Name	City	State
United States	Michigan Head Pain & Neurological Institute	Ann Arbor	Michigan
United States	Montefiore Headache Center	Bronx	New York
United States	Carolina Headache Institute	Chapel Hill	North Carolina
United States	Thomas Jefferson Headache Center	Philadelphia	Pennsylvania
United States	UCSF Headache Center	San Francisco	California
United States	Headache Care Center	Springfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
ElectroCore LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety - Number of Participants With Adverse Events	Safety was assessed by collecting Adverse Effects	Up to 8 weeks - duration of the Randomized period
Secondary	Mean Change in Headache Days	Mean change in headache days. Change between 4 week run in period to the 8 weeks randomized period.	Run-in period (4 weeks no treatment) and Randomized period (8 weeks)
Secondary	Total Number of Headache Days Per Arm With Peak Severity of Mild, Moderate, or Severe	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.	Run-in (4 weeks no treatment) and Randomized (8 weeks)
Secondary	Use of Pain Relief Medication	All abortive headache medication taken during randomized period	Randomized period - 8 weeks
Secondary	Mean Change in Quality of Life Short Form Survey (SF-12)	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.	Run-in (4 weeks) and Randomized period (8 weeks)

External Links

•   Effect of noninvasive vagus nerve stimulation on acute migraine: An open-label pilot study