Relief of Migraine Pain Through Electro Stimulation

Theranica

Status

Completed

Conditions

Migraine Headache

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT02453399

RMB001115

Details and patient eligibility

About

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.

Full 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.

Enrollment

87 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.