A Randomized, Double-blind Clinical Investigation to Evaluate the Use of the Relievion™ Device in Treating Migraine.

Neurolief

Status

Terminated

Conditions

Migraine

Treatments

Device: Relievion Device- Treatment Stimulation

Device: Relievion Device- Sham stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT03185559

NRLF-0038-17-MMC-CTIL

Details and patient eligibility

About

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, Relievion™).

Enrollment

8 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III (International Classification of Headache Disorders) beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
Capable of cooperating with the study protocol and to sign an informed consent.

Exclusion criteria

Patients having received Botox treatment in the head region in the prior 4 months.
Patients having received supraorbital or occipital nerve blocks in the prior 4 months.
History of Medication Overuse Headache.
Patients using opioid medication.
Allodynia: intolerance to supraorbital and/or occipital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 3 minutes of neurostimulation).
Implanted metal or electrical devices in the head (not including dental implants).
Patient having had a previous experience with the Relievion™ device.
Patients who have concomitant epilepsy.
History of neurosurgical interventions.
Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
History of drug abuse or alcoholism.
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.
Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).