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Migraine HeadacheNCT02453399

Relief of Migraine Pain Through Electro Stimulation

A study of Migraine Headache, run by Theranica at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine Headache
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
87 participants
Where
1 siteIsrael
Study dates
Jul 2015to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Matches International Headache Society criteria for migraine with and without aura
  • Reports 2-8 migraine attacks per month

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Rambam Medical Center

    Haifa

Other trials in Israel

About this study

Official title: Relief of Migraine Pain Through Transcutaneous Electro Stimulation

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.

Read the 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.

Being tested
Randomized treatment/placebo delivery of transcutaneous electro stimulation via a dedicated device Avital.
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Transcutaneous electro stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2.5 hours

  2. 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.

    Measured: 2.5 hours

  3. 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

    Measured: 2.5 hours

Secondary outcomes (6)

  1. 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 .

    Measured: 2.5 hours

  2. Use of pain relief medications as assessed by participants' reports at follow-up.

    Use of pain relief medications, including dosage

    Measured: 6 months

  3. Number of migraine attacks per month as determined by the number of activations.

    Measured: 6 months

  4. Overall wellbeing as assessed by means of post-study questionnaire

    Measured: 6 months

  5. Treatment related adverse effects, as assessed by means of post-study questionnaire, or participants' reports during the study.

    Measured: 6 months

  6. 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 .

    Measured: 0.5 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionApr 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02453399
Sponsor's protocol ID
RMB001115
Status last verified
May 2016
First submitted
13 May 2015
Last updated
8 Dec 2017
Results posted
No
Data monitoring committee
No

Publications

  • Yarnitsky D, Volokh L, Ironi A, Weller B, Shor M, Shifrin A, Granovsky Y. Nonpainful remote electrical stimulation alleviates episodic migraine pain. Neurology. 2017 Mar 28;88(13):1250-1255. doi: 10.1212/WNL.0000000000003760. Epub 2017 Mar 1.

    PubMed 28251920

Questions about this trial

What is this clinical trial studying?

A study of Migraine Headache, run by Theranica at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02453399, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2017.

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