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Completed

NCT Number: NCT03398668

Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

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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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laniado Medcial Center

Netanya, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females Ages of 18 to 65 years old.
  • 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).
  • Capable to corporate 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 that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 10 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 with child bearing potential without medically acceptable method of contraception.
  • History of cerebrovascular event.
  • Subjects with recent brain or facial trauma (occurred less than 3 months prior to this study).
  • Patients using Cannabis
  • Patients with head circumference smaller than 51 centimeters or head circumference larger than 60 centimeters.

Treatment and study plan

Relievion device- Treatment stimulation

Device

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

Other names: Neurolief device

Relievion Device- Sham stimulation

Device

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

Other names: Sham Neurolief device

Primary outcomes

  1. Mean change of pain score (measured on a visual analog scale=VAS) at 1 hour compared to baseline

    Time frame: 1 hour

    visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain

Secondary outcomes

  1. Mean change of pain score (measured by VAS) at 2 hours compared to baseline (if rescue therapy was not used).

    Time frame: 2 hours

    visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable painbaseline (if rescue therapy was not used).

  2. Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used).

    Time frame: 24 hours

    Mean change of pain score (measured by VAS) at 24 hours compared to baseline (if rescue therapy was not used).

  3. Proportion of patients not having required rescue medication within 24 hours

    Time frame: 24 hours

    Proportion of patients not having required rescue medication within 24 hours

  4. Proportion of patients not having required rescue medication at 2 hours compared to baseline.

    Time frame: 2 hours

    Proportion of patients not having required rescue medication at 2 hours

  5. Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used).

    Time frame: 1, 2, 24 hours

    Proportion of patients pain free at 1,2 and 24 hours from baseline (if rescue therapy was not used).

  6. Proportion of "responders" ("responder" is defined as decrease of at least 50% in VAS pain score from baseline) at 1,2 and 24 hours from baseline (if rescue therapy was not used).

    Time frame: 1, 2, 24 hours

    visual analog scale (VAS) for pain score assessment: 11 point scale 0-no pain, 10-Intolerable pain

Other outcomes

  1. Safety endpoints will consist of recording of adverse events and serious adverse events during the study. Device related adverse events will be evaluated between study groups

    Time frame: 1, 2, 24 hours

    Safety endpoints will consist of recording of adverse events and serious adverse events during the study. Device related adverse events will be evaluated between study groups

Sponsors and collaborators

Lead sponsor

Neurolief Ltd.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2018
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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