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

This study is not yet open for participant recruitment.
Verified June 2017 by Neurolief Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03185559
First Posted: June 14, 2017
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Neurolief Ltd.
  Purpose
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 Intervention
Migraine Device: Relievion Device- Treatment Stimulation Device: Relievion Device- Sham stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind, Parallel-group, Sham Controlled Single-center Pivotal Clinical Investigation to Evaluate the Clinical Safety and Performance of Self-administered Home-use Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation Device (Relievion™) in Treating Migraine.

Resource links provided by NLM:


Further study details as provided by Neurolief Ltd.:

Primary Outcome Measures:
  • Pain Visual Analogue Scale (VAS) Change from basline to 1 hour [ Time Frame: 1 Hour ]
    Mean change of pain score (measured on a visual analog scale) at 1 hour compared to baseline (if rescue therapy was not used)


Secondary Outcome Measures:
  • Pain VAS change from baseline to 30 minutes [ Time Frame: 30 minutes ]
    Mean change of pain score (measured on a visual analog scale) at 30 minutes compared to baseline (if rescue therapy was not used).

  • Pain VAS change from baseline to 2 hours [ Time Frame: 2 Hours ]
    Mean change of pain score (measured on a visual analog scale) at 2 hours compared to baseline (if rescue therapy was not used).

  • Pain VAS change from baseline to 24 hours [ Time Frame: 24 Hours ]
    Mean change of pain score (measured on a visual analog scale) at 24 hours compared to baseline (if rescue therapy was not used).

  • Pain VAS change from baseline to 48 hours [ Time Frame: 48 Hours ]
    Mean change of pain score (measured on a visual analog scale) at 48 hours compared to baseline (if rescue therapy was not used).

  • Rescue medication at 2 hours [ Time Frame: 2 hours ]
    Proportion of patients not having required rescue medication at 2 hours

  • Rescue medication within 24 hours [ Time Frame: 24 hours ]
    Proportion of patients not having required rescue medication within 24 hours

  • Rescue medication within 48 hours [ Time Frame: 48 hours ]
    Proportion of patients not having required rescue medication within 48 hours


Estimated Enrollment: 86
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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

  Eligibility

Information from the National Library of Medicine

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

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).
  Contacts and Locations
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): NCT03185559


Contacts
Contact: Amir Cohen +9725322553 amir.cohen@neurolief.com

Locations
Israel
Meir General Hospital Not yet recruiting
Kfar Saba, Israel
Contact: Colin Klein, Dr.       colin.klein@clalit.org.il   
Contact: Rachel Hering, Dr.       hering@post.tau.ac.il   
Sub-Investigator: Rachel Hering, Dr.         
Principal Investigator: Colin Klein, Dr.         
Sponsors and Collaborators
Neurolief Ltd.
Investigators
Principal Investigator: Colin Klein, Dr Meir Medical Center, Kfar Saba, Israel
  More Information

Responsible Party: Neurolief Ltd.
ClinicalTrials.gov Identifier: NCT03185559     History of Changes
Other Study ID Numbers: NRLF-0038-17-MMC-CTIL
First Submitted: June 11, 2017
First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: June 2017
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