NCT02453399

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 25, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

December 8, 2017

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

May 13, 2015

Last Update Submit

December 6, 2017

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    2.5 hours

Secondary Outcomes (6)

  • 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 .

    2.5 hours

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

    6 months

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

    6 months

  • Overall wellbeing as assessed by means of post-study questionnaire

    6 months

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

    6 months

  • +1 more secondary outcomes

Interventions

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

Transcutaneous electro stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

Related Publications (1)

  • 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.

    PMID: 28251920DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • David Yarnitsky, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 25, 2015

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

December 8, 2017

Record last verified: 2016-05

Locations

IL(1)