Relief of Migraine Pain Through Electro Stimulation
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|ClinicalTrials.gov Identifier: NCT02453399|
Recruitment Status : Completed
First Posted : May 25, 2015
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Device: Randomized treatment/placebo delivery of transcutaneous electro stimulation via a dedicated device Avital.||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Relief of Migraine Pain Through Transcutaneous Electro Stimulation|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||May 2016|
Device: Randomized treatment/placebo delivery of transcutaneous electro stimulation via a dedicated device Avital.
- 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 [ Time Frame: 2.5 hours ]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.
- Percent responders resulted in significant pain relief at 2 hours post treatment [ Time Frame: 2.5 hours ]Percent of responders with improvement of 50% or better in pain level according to NPS
- 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. [ Time Frame: 6 months ]Use of pain relief medications, including dosage
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02453399
|Rambam Medical Center|
|Principal Investigator:||David Yarnitsky, MD||Rambam Health Care Campus|