this study will evaluate the clinical performance and safety of a self administered abortive treatment for migraine headache using combined occipital and supraorbital transcutaneous nerve stimulator (Neurolief device, Relivion®)
The Relivion® is a non-invasive transcutaneous neuro-stimulator is indicated for the acute treatment of migraine with or without aura in subjects 18 years of age or older. The Relivion® is intended to be a prescription device, self-used at home.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
187
1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation
1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation
Clinical Research Consortium, an AMR company
Tempe, Arizona, United States
Hartford HealthCare Headache Center
Hartford, Connecticut, United States
Yale School of Medicine
New Haven, Connecticut, United States
Proportion of Subjects Reporting Reduction of Migraine Headache Pain at 2 Hours From Treatment Initiation
the number and percent of subjects reporting reduction of migraine headache pain 2 hours post treatment initiation from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack (if rescue therapy was not used)
Time frame: 2 hours from treatment initiation
Proportion of Subjects Reporting Improvement in Their Most Bothersome Symptom (MBS) Other Than a Headache, 2 Hours Post-treatment Initiation
The number and percentage of subjects reporting improvement in their Most Bothersome Symptom (MBS) other than a headache, 2 hours post-treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack. MBS may be nausea, photophobia, phonophobia
Time frame: 2 hours from treatment initiation
Proportion of Subjects Reporting Reduction of Migraine Headache Pain 1-hour Post Treatment Initiation
The number and percentage of subjects reporting reduction of migraine headache pain 1-hour post treatment initiation (if rescue therapy was not used), from severe or moderate to mild or no pain, or from mild to no pain, in their first eligible treated migraine attack
Time frame: 1 hour from treatment initiation
Proportion of Subjects Who Are Pain Free at 2 Hours Post Treatment Initiation
The number and percentage of subjects who are pain free at 2 hours post treatment initiation (if rescue therapy was not used), in their first eligible treated migraine attack
Time frame: 2 hours from treatment initiation
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Regeneris Medical
North Attleboro, Massachusetts, United States
Clinical Research Consortium, an AMR company
Las Vegas, Nevada, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Barzilai MC
Ashkelon, Israel
Hillel Yaffe Medical Center
Hadera, Israel
Sharei Zedek MC
Jerusalem, Israel
Macabi healtcenter services
Kfar Saba, Israel
...and 2 more locations