Non-invasive Neurostimulation for the Relief of Migraine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03410628|
Recruitment Status : Terminated (Company decision)
First Posted : January 25, 2018
Results First Posted : July 25, 2018
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Device: gammaCore||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-invasive Neurostimulation of the Vagus Nerve With the gammaCore Device for the Relief of Pain and Allodynia Associated With Migraine|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||December 2011|
Experimental: gammaCore Active Device
Non-invasive vagal nerve stimulator
- Safety - Number of Participants With Adverse Events [ Time Frame: Up to 4 months ]Safety was assessed by collecting adverse events for the duration of the study
- Change in Headache Pain Severity From Baseline to 120 Minutes for First Treated Migraine Attack [ Time Frame: 120 minutes ]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.