Migraine Clinical Trial
Official title:
The SP-303 PERL Study - Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for Preventive Treatment of Migraine
The PERL Study will evaluate the safety and efficacy of a self-administered preventive treatment for migraine headache using combined occipital and trigeminal nerve stimulation (Relivion®). This is a prospective, non-randomized, single arm, multi-center study designed to evaluate the use of Relivion® in reducing the frequency of headache days against a sham performance goal.
The study will include the following study visits & phases: - Visit 1 Screening - Run-in (Baseline) Period - Daily migraine headache diary. - Visit 2 Enrollment -Study enrollment, device and regimen training. - Treatment Period- Relivion® migraine preventive treatment for 12 consecutive weeks. Patients will be required to fill in a daily migraine diary. - Visit 3 Follow Up Visit. - Visit 4 Follow Up Visit. - Visit 5 End of study. After completion of visit 5 the subject's participation will be over. ;
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