Short-term Effectiveness of Transcutaneous Nerve Stimulation in Reducing Migraine Related Pain

January 6, 2016 updated by: Neurolief Ltd.

A Prospective, Randomized, Single Blind, Parallel-group, Placebo Controlled Clinical Study to Evaluate the Short-term Effectiveness of Combined Occipital and Supraorbital Transcutaneous Nerve Stimulation (OS-TNS) in Reducing Migraine Related Pain

The purpose of this study is to evaluate the short-term effectiveness of combined occipital and supraorbital transcutaneous nerve stimulation in reducing migraine related pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with confirmed diagnosis of migraine headache without aura or with typical migraine with aura (ICHD-II code 1.2.1 or 1.1).
  • Subjects with 1-6 migraine episodes per month in the last 2 months.
  • The subject is capable of understanding the study and to sign an informed consent.

Exclusion Criteria:

  • Subjects who have concomitant epilepsy.
  • History of neurosurgical interventions.
  • Subjects with metal implants or shrapnel in their head, except for dental implants.
  • Subjects with implanted cardiac pacemaker, neurostimulators, surgical clips (above the shoulder line) or any medical pumps.
  • History of drug abuse or alcoholism.
  • History of medications overuse headache.
  • Participation in current clinical study or participated in a clinical study within 3 months prior to this study.
  • Skin lesion or inflammation at the region of the stimulating electrodes.
  • Personality or somatoform disorder.
  • Pregnancy or Lactation.
  • Women of reproductive age not using efficient contraceptive method.
  • History of cerebrovascular event.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OSTNS Neurostimulator
Combined Occipital & Supraorbital Transcutaneous Neurostimulator.
Device: OSTNS Neurostimulator
Non-invasive transcutaneous neurostimulation.
Other Names:
  • Transcutaneous Neurostimulator.
Placebo Comparator: Placebo OSTNS Neurostimulator
Placebo Combined Occipital & Supraorbital Transcutaneous Neurostimulator.
Device: Placebo OSTNS Neurostimulator
Placebo non-invasive transcutaneous neurostimulation
Other Names:
  • Transcutaneous Neurostimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain visual analogue scale (VAS)
Time Frame: 20-60 minutes of treatment.
The primary endpoint will be defined based on relative change (%) in pain VAS score from baseline to end of treatment without using pain relief medication.
20-60 minutes of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Responder" rate at 20-60 minutes of treatment.
Time Frame: 20-60 minutes of treatment.
- Evaluated using pain VAS; a responder will be defined by a decrease of 50% or more in the pain VAS from baseline to end of treatment without using pain relief medication.
20-60 minutes of treatment.
"Responder" rate at 15 minutes of treatment
Time Frame: Baseline, 15 minutes of treatment
Responder" rate at 15 minutes of treatment - Evaluated using pain VAS; a responder will be defined by a decrease of 50% or more in the pain VAS from baseline to end of treatment without using pain relief medication.
Baseline, 15 minutes of treatment
Sustained "Responder" rate at 24 hours post treatment
Time Frame: Baseline, 24 hours post treatment
Sustained "responders" rate at 24 hours: The percentage of study participants who will be defined as a "responder" at 2 hour and will not use pain relief medication or suffer from relapse (recurrence) within the subsequent 24 hours.
Baseline, 24 hours post treatment
"Headache relief" rate- at 2 hours
Time Frame: Baseline, 2 hours
"Headache relief" rate- the percentage of subjects with a decrease in headache from severe or moderate to none or mild within 2 hours, before any pain relief medication.
Baseline, 2 hours
Sustained "headache relief" at 24 hours
Time Frame: Baseline, 24 hours
The percentage of study participants who will be defined as having a "headache relief" at 2 hour and will not use pain relief medication or suffer from relapse (recurrence) within the subsequent 24 hours.
Baseline, 24 hours
Pain free at 2 hours
Time Frame: Baseline, 2 hours
Percentage of subjects that are pain free at 2 hours
Baseline, 2 hours
Sustained pain freedom at 24 hours
Time Frame: Baseline, 24 hours
The percentage of study participants who will be defined as "pain free" at 2 hour and will not use pain relief medication or suffer from relapse (recurrence) within the subsequent 24 hours.
Baseline, 24 hours
Functional disability change 2 hours from end of treatment
Time Frame: Baseline, 2 Hours post treatment
Functional disability change 2 hours from end of treatment without using pain relief medication.
Baseline, 2 Hours post treatment
Time until use of pain relief medication.
Time Frame: Baseline- 24 hours.
Time until use of pain relief medication.
Baseline- 24 hours.
Presence of nausea, vomiting, photophobia, phonophobia.
Time Frame: Baseline- 24 hours.
Presence of nausea, vomiting, photophobia, phonophobia.
Baseline- 24 hours.
Percentage of subjects who completed the treatment.
Time Frame: Baseline-20 minutes of treatment
Percentage of subjects who completed at least 20 minutes the treatment.
Baseline-20 minutes of treatment
Global impression of effect
Time Frame: Baseline- 24 hours.
Global impression of effect- A simple Likert-type verbal scale: very poor, poor, no opinion, good, very good.
Baseline- 24 hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurolief Ltd.

Investigators

  • Principal Investigator: Rachel Hering, Dr., Director of headache clinic, Department of Neurology, Meir General Hospital, Kfar Saba, Israel.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 3, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Estimate)

January 7, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRLF-0086-14-MMC-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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