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Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

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ClinicalTrials.gov Identifier: NCT03398668
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Neurolief Ltd.

Brief Summary:
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™).

Condition or disease Intervention/treatment Phase
Migraine Device: Relievion device- Treatment stimulation Device: Relievion Device- Sham stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine
Actual Study Start Date : February 22, 2018
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: Relievion device- Treatment stimulation
Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation
Device: Relievion device- Treatment stimulation
1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation
Other Name: Neurolief device

Sham Comparator: Sham Comparator: Relievion device- Sham Stimulation
Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation
Device: Relievion Device- Sham stimulation
1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation
Other Name: Sham Neurolief device




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398668


Contacts
Contact: Michal Kedar-Datel +972-52-6659806 michal.kedar-datel@neurolief.com

Locations
Israel
Laniado Medcial Center Recruiting
Netanya, Israel
Contact: Lena Rosenmann, Mrs.         
Principal Investigator: Daniel Oved, Dr.         
Sponsors and Collaborators
Neurolief Ltd.
Investigators
Principal Investigator: Daniel Dr. Oved, Dr. Laniado Medical center

Responsible Party: Neurolief Ltd.
ClinicalTrials.gov Identifier: NCT03398668     History of Changes
Other Study ID Numbers: SP301
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases