An interventional study of Randomized treatment/placebo delivery of transcutaneous electro stimulation via a dedicated device Avital. in Migraine Headache, sponsored by Theranica. Completed at 1 site in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by Theranica · Not applicable, Interventional, and Treatment
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.
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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 87 is close to the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Theranica is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Transcutaneous electro stimulation
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.
Time frame: 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.
Time frame: 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
Time frame: 2.5 hours
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 .
Time frame: 2.5 hours
Use of pain relief medications as assessed by participants' reports at follow-up.
Use of pain relief medications, including dosage
Time frame: 6 months
Number of migraine attacks per month as determined by the number of activations.
Time frame: 6 months
Overall wellbeing as assessed by means of post-study questionnaire
Time frame: 6 months
Treatment related adverse effects, as assessed by means of post-study questionnaire, or participants' reports during the study.
Time frame: 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 .
Time frame: 0.5 hours
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Theranica