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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
59
UCSF Headache Center
San Francisco, California, United States
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
Headache Care Center
Springfield, Missouri, United States
Montefiore Headache Center
The Bronx, New York, United States
Safety - Number of Participants With Adverse Events
Safety was assessed by collecting Adverse Effects
Time frame: Up to 8 weeks - duration of the Randomized period
Mean Change in Headache Days
Mean change in headache days. Change between 4 week run in period to the 8 weeks randomized period.
Time frame: Run-in period (4 weeks no treatment) and Randomized period (8 weeks)
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.
Time frame: Run-in (4 weeks no treatment) and Randomized (8 weeks)
Use of Pain Relief Medication
All abortive headache medication taken during randomized period
Time frame: Randomized period - 8 weeks
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.
Time frame: Run-in (4 weeks) and Randomized period (8 weeks)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Carolina Headache Institute
Chapel Hill, North Carolina, United States
Thomas Jefferson Headache Center
Philadelphia, Pennsylvania, United States