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

Neurolief

Status

Completed

Conditions

Headache, Migraine

Treatments

Device: Placebo OSTNS Neurostimulator

Device: OSTNS Neurostimulator

Study type

Interventional

Funder types

Industry

Identifiers

NCT02438553

NRLF-0086-14-MMC-CTIL

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.