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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Headache, Migraine

Intervention / Treatment
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* Device: OSTNS Neurostimulator
* Device: Placebo OSTNS Neurostimulator


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OSTNS Neurostimulator<br>Combined Occipital & Supraorbital Transcutaneous Neurostimulator. | Device: OSTNS Neurostimulator<br>* Non-invasive transcutaneous neurostimulation.<br>* Other names: Transcutaneous Neurostimulator.;|
| Placebo Comparator: Placebo OSTNS Neurostimulator<br>Placebo Combined Occipital & Supraorbital Transcutaneous Neurostimulator. | Device: Placebo OSTNS Neurostimulator<br>* Placebo non-invasive transcutaneous neurostimulation<br>* Other names: Transcutaneous Neurostimulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 20-60 minutes of treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Baseline, 24 hours | 
| Pain free at 2 hours | Percentage of subjects that are pain free at 2 hours | Baseline, 2 hours | 
| Sustained pain freedom at 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 | 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 until use of pain relief medication. | Baseline- 24 hours. | 
| Presence of nausea, vomiting, photophobia, phonophobia. | Presence of nausea, vomiting, photophobia, phonophobia. | Baseline- 24 hours. | 
| Percentage of subjects who completed the treatment. | Percentage of subjects who completed at least 20 minutes the treatment. | Baseline-20 minutes of treatment | 
| Global impression of effect | Global impression of effect- A simple Likert-type verbal scale: very poor, poor, no opinion, good, very good. | Baseline- 24 hours. |