NCT02453399

Relief of Migraine Pain Through Electro Stimulation

Relief of Migraine Pain Through Transcutaneous Electro Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Theranica · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Migraine Headache

Interventions

Type	Name	Description
DEVICE	Randomized treatment/placebo delivery of transcutaneous electro stimulation via a dedicated device Avital.	Transcutaneous electro stimulation

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-04-01
• Completion: 2016-05-01
• First posted: 2015-05-25
• Last updated: 2017-12-08

Locations

1 site across 1 country: Israel