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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neurolief Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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