Skip to main content
OpenTrials
Completed

NCT Number: NCT02438553

Short-term Effectiveness of Transcutaneous Nerve Stimulation 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Headache, Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Meir General Hospital

Kfar Saba, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OSTNS Neurostimulator

Device

Non-invasive transcutaneous neurostimulation.

Other names: Transcutaneous Neurostimulator.

Placebo OSTNS Neurostimulator

Device

Placebo non-invasive transcutaneous neurostimulation

Other names: Transcutaneous Neurostimulator

Primary outcomes

  1. 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.

Secondary outcomes

  1. "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.

  2. "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.

  3. 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.

  4. "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.

  5. 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.

  6. Pain free at 2 hours

    Time frame: Baseline, 2 hours

    Percentage of subjects that are pain free at 2 hours

  7. 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.

  8. 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.

  9. Time until use of pain relief medication.

    Time frame: Baseline- 24 hours.

    Time until use of pain relief medication.

  10. Presence of nausea, vomiting, photophobia, phonophobia.

    Time frame: Baseline- 24 hours.

    Presence of nausea, vomiting, photophobia, phonophobia.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Neurolief Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 8, 2015
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.