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

Neurolief Ltd.40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Headache, Migraine

Interventions

OSTNS NeurostimulatorDEVICE

Non-invasive transcutaneous neurostimulation.

Placebo OSTNS NeurostimulatorDEVICE

Placebo non-invasive transcutaneous neurostimulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Meir General Hospital

Kfar Saba, Israel

Outcomes

Primary Outcomes

Pain visual analogue scale (VAS)

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.

Time frame: 20-60 minutes of treatment.

Secondary Outcomes

"Responder" rate at 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.

Time frame: 20-60 minutes of treatment.

"Responder" rate at 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.

Time frame: Baseline, 15 minutes of treatment

Sustained "Responder" rate at 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.

Time frame: Baseline, 24 hours post treatment

"Headache relief" rate- at 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.

Time frame: Baseline, 2 hours

Sustained "headache relief" at 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.

Data from ClinicalTrials.gov

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