Relief of Migraine Pain Through Electro Stimulation

Migraine Headache Clinical Trial

Official title:

Relief of Migraine Pain Through Transcutaneous Electro Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02453399
• Other study ID #: RMB001115
• Status: Completed
• Phase: N/A
• First received: May 13, 2015
• Last updated: December 6, 2017
• Start date: July 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Theranica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headache

Intervention

Device:
• Randomized treatment/placebo delivery of transcutaneous electro stimulation via a dedicated device Avital.
Transcutaneous electro stimulation

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Theranica

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Use of pain relief medications as assessed by participants' reports at follow-up.	Use of pain relief medications, including dosage	6 months
Secondary	Number of migraine attacks per month as determined by the number of activations.		6 months
Secondary	Overall wellbeing as assessed by means of post-study questionnaire		6 months
Secondary	Treatment related adverse effects, as assessed by means of post-study questionnaire, or participants' reports during the study.		6 months
Secondary	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