NCT03185559

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™).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 23, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

6 months

First QC Date

June 11, 2017

Last Update Submit

March 27, 2018

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • Pain Visual Analogue Scale (VAS) Change from basline to 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)

    1 Hour

Secondary Outcomes (7)

  • Pain VAS change from baseline to 30 minutes

    30 minutes

  • Pain VAS change from baseline to 2 hours

    2 Hours

  • Pain VAS change from baseline to 24 hours

    24 Hours

  • Pain VAS change from baseline to 48 hours

    48 Hours

  • Rescue medication at 2 hours

    2 hours

  • +2 more secondary outcomes

Study Arms (2)

Relievion device- Treatment stimulation

ACTIVE COMPARATOR

Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation

Device: Relievion Device- Treatment Stimulation

Relievion device- Sham Stimulation

SHAM COMPARATOR

Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation

Device: Relievion Device- Sham stimulation

Interventions

Relievion Device- Treatment StimulationDEVICE

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

Also known as: Neurolief device
Relievion device- Treatment stimulation
Relievion Device- Sham stimulationDEVICE

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

Also known as: Sham Neurolief device
Relievion device- Sham Stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir General Hospital

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Colin Klein, Dr

    Meir Medical Center, Kfar Saba, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2017

First Posted

June 14, 2017

Study Start

July 23, 2017

Primary Completion

January 9, 2018

Study Completion

January 9, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)