Short-term Effectiveness of Transcutaneous Nerve Stimulation in Reducing Migraine Related Pain

A Prospective, Randomized, Single Blind, Parallel-group, Placebo Controlled Clinical Study to Evaluate the Short-term Effectiveness of Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation (OS-TNS) in Reducing Migraine Related Pain

The purpose of this study is to evaluate the short-term effectiveness of combined occipital and supraorbital transcutaneous nerve stimulation in reducing migraine related pain.

Inclusion Criteria:

• Subjects with confirmed diagnosis of migraine headache without aura or with typical migraine with aura (ICHD-II code 1.2.1 or 1.1).
• Subjects with 1-6 migraine episodes per month in the last 2 months.
• The subject is capable of understanding the study and to sign an informed consent.

Exclusion Criteria:

• Subjects who have concomitant epilepsy.
• History of neurosurgical interventions.
• Subjects with metal implants or shrapnel in their head, except for dental implants.
• Subjects with implanted cardiac pacemaker, neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
• History of drug abuse or alcoholism.
• History of medications overuse headache.
• Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
• Skin lesion or inflammation at the region of the stimulating electrodes.
• Personality or somatoform disorder.
• Pregnancy or Lactation.
• Women of reproductive age not using efficient contraceptive method.
• History of cerebrovascular event.