Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

NCT03398668 | Completed

• 1 other identifier: SP301
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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™).

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

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

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

  1 hour

Secondary Outcomes (6)

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

  2 hours

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

  24 hours

• Proportion of patients not having required rescue medication within 24 hours

  24 hours

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

  2 hours

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

  1, 2, 24 hours

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

  1, 2, 24 hours

Study Arms (2)

Relievion device- Treatment stimulation

ACTIVE COMPARATOR

Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation

Device: Relievion device- Treatment stimulation

Sham Comparator: 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 stimulation DEVICE

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

Also known as: Neurolief device

Relievion device- Treatment stimulation

Relievion Device- Sham stimulation DEVICE

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

Also known as: Sham Neurolief device

Sham Comparator: Relievion device- Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Neurolief Ltd.: lead

Study Sites (1)

Laniado Medcial Center

Netanya, Israel

Location

Related Publications (1)

• Daniel O, Tepper SJ, Deutsch L, Sharon R. External Concurrent Occipital and Trigeminal Neurostimulation Relieves Migraine Headache: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial. Pain Ther. 2022 Sep;11(3):907-922. doi: 10.1007/s40122-022-00394-w. Epub 2022 Jun 4.

  PMID: 35661128 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Dr. Oved, Dr.

  Laniado Medical center

  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: January 8, 2018
• First Posted: January 12, 2018
• Study Start: February 22, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)