Relief of Migraine Pain Through Electro Stimulation

Relief of Migraine Pain Through Transcutaneous Electro Stimulation

This study will evaluate transcutaneous electro stimulation device developed by Siano for adequacy, safety and efficacy for the treatment and/or prevention of migraine pain for migraine sufferers.

Study Overview

• Status: Completed
• Conditions: Migraine Headache
• Intervention / Treatment: Device: Randomized treatment/placebo delivery of transcutaneous electro stimulation via a dedicated device Avital.

Detailed Description

This study will gather information regarding performance of Avital transcutaneous electro stimulation device developed by Siano. Electrostimulation in the form of weak electrical pulses arranged in specific patterns (programs), is delivered through adhesive electrodes attached to patient's skin. A set of stimulation programs, out of which one is placebo, is stored in device memory.The device is controlled wirelessly using a dedicated smartphone application. Participants will be instructed to attach and activate the device at the onset of a migraine attack and manually adjust stimulation intensity to a level where it is perceivable but not painful. Upon each activation, a program will be automatically picked for execution in random order. Randomization is performed within and between subjects. Subjects will not be aware of the executed program. Subjects are requested to refrain from use of migraine relief drugs prior to treatment and during the first two hours of the treated attack. Throughout the course of electrostimulation, participants will be requested to rate their migraine pain level via te same smartphone application, using Visual Analog Scale (VAS).

Overall experimental duration for each participant will be determined by the goal of using the Avital device for 10-20 migraine attacks.

Data containing activation times, executed programs, stimulation intensity and user feedback will be transmitted via the smartphone to a central database for analysis. All data are completely de-identified and linked to a unique code assigned to each device. The link between participant's ID and this code will be securely maintained by the research coordinator. Database will be overseen by Siano staff responsible for monitoring the clinical study. The electronic database will be used to generate outcome measures.

In the course of this study the investigators will obtain controlled data on the safety and efficacy of transcutaneous electro stimulation for migraine treatment using Siano developed transcutaneous electro stimulation device.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Matches International Headache Society criteria for migraine with and without aura
• Reports 2-8 migraine attacks per month

Exclusion Criteria:

• Has other significant pain problem (e.g.cancer pain, fibromyalgia or other head or facial disorder) that in the opinion of the investigator may confound the study assessments
• Has severe cardiac or cerebrovascular disease
• Has uncontrolled high blood pressure (systolic >160 diastolic > 100 after 3 repeated measurements within 24 hours)
• Is currently implanted with an electrical and/or neurostimulator device (e.g. cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator cochlear implant, Sphenopalatine ganglion stimulator or Occipital nerve stimulator)
• Known epilepsy
• Use of Cannabis including medical use.
• Has chronic migraine (more than 15 headache days per month).
• Has undergone nerve block (occipital or other) in the head or neck within the last 2 months.
• Has received Botox injections within the last 6 months.
• Is pregnant or thinking of becoming pregnant during the study period, or of childbearing years and is unwilling to use an accepted form of birth control.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine relief at 2 hours post treatment as determined by difference of reported pain levels at the beginning and 2 hours after the end of electro stimulation session. Pain levels are assessed by means of Numerical Pain Scale.		2.5 hours
Relative migraine pain relief at 2 hours post treatment	Relative migraine pain relief at 2 hours post treatment as determined by difference of reported pain levels at the beginning and 2 hours after the end of electro stimulation session normalized by pain level on start of the session. Pain levels are assessed by means of Numerical Pain Scale.	2.5 hours
Percent responders resulted in significant pain relief at 2 hours post treatment	Percent of responders with improvement of 50% or better in pain level according to NPS	2.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine attack duration as determined by time between reported onset of migraine attack and time when, for this attack, reported pain level drops by at least three levels. Pain levels are assessed by means of Visual Analog Scale .		2.5 hours
Use of pain relief medications as assessed by participants' reports at follow-up.	Use of pain relief medications, including dosage	6 months
Number of migraine attacks per month as determined by the number of activations.		6 months
Overall wellbeing as assessed by means of post-study questionnaire		6 months
Treatment related adverse effects, as assessed by means of post-study questionnaire, or participants' reports during the study.		6 months
Migraine Relief at end of treatment as determined by difference of reported pain levels at the beginning of the electro stimulation and in the end of the electro stimulation session. Pain levels are assessed by means of NPS .		0.5 hours

Collaborators and Investigators

• Sponsor: Theranica
• Investigators: Principal Investigator: David Yarnitsky, MD, Rambam Health Care Campus

Publications and helpful links

General Publications

• Yarnitsky D, Volokh L, Ironi A, Weller B, Shor M, Shifrin A, Granovsky Y. Nonpainful remote electrical stimulation alleviates episodic migraine pain. Neurology. 2017 Mar 28;88(13):1250-1255. doi: 10.1212/WNL.0000000000003760. Epub 2017 Mar 1.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (Estimate): May 25, 2015

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: RMB001115