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

Migraine Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03185559
• Other study ID #: NRLF-0038-17-MMC-CTIL
• Status: Terminated
• Phase: N/A
• First received: June 11, 2017
• Last updated: March 27, 2018
• Start date: July 23, 2017
• Est. completion date: January 9, 2018

Study information

• Verified date: March 2018
• Source: Neurolief Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: January 9, 2018
• Est. primary completion date: January 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• Relievion Device- Treatment Stimulation
1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation
• Relievion Device- Sham stimulation
1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation

Locations

Country	Name	City	State
Israel	Meir General Hospital	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Neurolief Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain VAS change from baseline to 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).	30 minutes
Secondary	Pain VAS change from baseline to 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).	2 Hours
Secondary	Pain VAS change from baseline to 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).	24 Hours
Secondary	Pain VAS change from baseline to 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).	48 Hours
Secondary	Rescue medication at 2 hours	Proportion of patients not having required rescue medication at 2 hours	2 hours
Secondary	Rescue medication within 24 hours	Proportion of patients not having required rescue medication within 24 hours	24 hours
Secondary	Rescue medication within 48 hours	Proportion of patients not having required rescue medication within 48 hours	48 hours