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Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

Primary Purpose

Migraine

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Relievion device- Treatment stimulation

Relievion Device- Sham stimulation

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Laniado Medcial Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Relievion device- Treatment stimulation

Sham Comparator: Relievion device- Sham Stimulation

Arm Description

Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation

Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Proportion of patients not having required rescue medication within 24 hours

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

Proportion of patients not having required rescue medication at 2 hours

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

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).

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

Full Information

NCT ID

NCT03398668

First Posted

January 8, 2018

Last Updated

March 11, 2019

Sponsor

Neurolief Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03398668

Brief Title

Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

Official Title

Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

February 22, 2018 (Actual)

Primary Completion Date

December 30, 2018 (Actual)

Study Completion Date

December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neurolief Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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™).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Relievion device- Treatment stimulation

Arm Type

Active Comparator

Arm Description

Relievion Device- Treatment combined occipital and supraorbital transcutaneous nerve stimulation

Arm Title

Sham Comparator: Relievion device- Sham Stimulation

Arm Type

Sham Comparator

Arm Description

Relievion Device- Sham combined occipital and supraorbital transcutaneous nerve stimulation

Intervention Type

Device

Intervention Name(s)

Relievion device- Treatment stimulation

Other Intervention Name(s)

Neurolief device

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Relievion Device- Sham stimulation

Other Intervention Name(s)

Sham Neurolief device

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

2 hours

Title

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

Description

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

Time Frame

24 hours

Title

Proportion of patients not having required rescue medication within 24 hours

Description

Proportion of patients not having required rescue medication within 24 hours

Time Frame

24 hours

Title

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

Description

Proportion of patients not having required rescue medication at 2 hours

Time Frame

2 hours

Title

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

Description

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

Title

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).

Description

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

Time Frame

1, 2, 24 hours

Other Pre-specified Outcome Measures:

Title

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

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Dr. Oved, Dr.

Organizational Affiliation

Laniado Medical center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laniado Medcial Center

City

Netanya

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35661128

Citation

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.

Results Reference

derived

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Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation for Treatment of Migraine

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