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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
UCSF Headache Center
San Francisco, California, United States
New York Headache Center
New York, New York, United States
Montefiore Headache Center
The Bronx, New York, United States
Safety - Number of Participants With Adverse Effects
The primary outcome measure for this study was the assessment of adverse events as unanticipated or anticipated.
Time frame: End of Study - 7 weeks
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
Time frame: 120 minutes
Change in Photophobia (Visual) From Baseline to 120 Minutes
Presence of photophobia (yes or no) was captured at baseline and 120 minutes.
Time frame: Base line 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.
Time frame: 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.
Time frame: Baseline 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.
Time frame: Baseline and 120 minutes
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