Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-22

Study Completion Date

2018-12-30

Brief Summary

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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™).

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Relievion device- Treatment stimulation

Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation

Group Type ACTIVE_COMPARATOR

Relievion device- Treatment stimulation

Intervention Type DEVICE

1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation

Sham Comparator: Relievion device- Sham Stimulation

Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation

Group Type SHAM_COMPARATOR

Relievion Device- Sham stimulation

Intervention Type DEVICE

1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation

Interventions

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Relievion device- Treatment stimulation

1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation

Intervention Type DEVICE

Relievion Device- Sham stimulation

1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation

Intervention Type DEVICE

Other Intervention Names

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Neurolief device Sham Neurolief device

Eligibility Criteria

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Inclusion Criteria

1. Males and females Ages of 18 to 65 years old.
2. History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD (International Classification of Headache Disorders)-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction).
3. Capable to corporate with the study protocol and to sign an informed consent.

Exclusion Criteria

1. Patients having received Botox treatment in the head region in the prior 4 months.
2. Patients having received supraorbital or occipital nerve blocks in the prior 4 months.
3. History of Medication Overuse Headache.
4. Patients using opioid medication.
5. Allodynia: intolerance to supraorbital and/or occipital neurostimulation that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 10 minutes of neurostimulation).
6. Implanted metal or electrical devices in the head (not including dental implants).
7. Patient having had a previous experience with the Relievion™ device.
8. Patients who have concomitant epilepsy.
9. History of neurosurgical interventions.
10. Patients with implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
11. History of drug abuse or alcoholism.
12. Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
13. Skin lesion or inflammation at the region of the stimulating electrodes.
14. Personality or somatoform disorder.
15. Pregnancy or Lactation.
16. Women with child bearing potential without medically acceptable method of contraception.
17. History of cerebrovascular event.
18. Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).
19. Patients using Cannabis
20. Patients with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No