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

Not Applicable

Completed

• Conditions: Headache, Migraine
• Interventions: Device: OSTNS Neurostimulator; Device: Placebo OSTNS Neurostimulator

• Registration Number: NCT02438553
• Lead Sponsor: Neurolief Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-03
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OSTNS Neurostimulator	OSTNS Neurostimulator	Combined Occipital \& Supraorbital Transcutaneous Neurostimulator.
Placebo OSTNS Neurostimulator	Placebo OSTNS Neurostimulator	Placebo Combined Occipital \& Supraorbital Transcutaneous Neurostimulator.

Primary Outcome Measures

Name	Time	Method
Pain visual analogue scale (VAS)	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 Outcome Measures

Name	Time	Method
Time until use of pain relief medication.	Baseline- 24 hours.	Time until use of pain relief medication.
Percentage of subjects who completed the treatment.	Baseline-20 minutes of treatment	Percentage of subjects who completed at least 20 minutes the treatment.
Sustained "Responder" rate at 24 hours post treatment	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.
"Responder" rate at 20-60 minutes of treatment.	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.
"Headache relief" rate- at 2 hours	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.
Sustained "headache relief" at 24 hours	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.
Sustained pain freedom at 24 hours	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.
Functional disability change 2 hours from end of treatment	Baseline, 2 Hours post treatment	Functional disability change 2 hours from end of treatment without using pain relief medication.
Pain free at 2 hours	Baseline, 2 hours	Percentage of subjects that are pain free at 2 hours
"Responder" rate at 15 minutes of treatment	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.
Presence of nausea, vomiting, photophobia, phonophobia.	Baseline- 24 hours.	Presence of nausea, vomiting, photophobia, phonophobia.
Global impression of effect	Baseline- 24 hours.	Global impression of effect- A simple Likert-type verbal scale: very poor, poor, no opinion, good, very good.

Trial Locations

Locations (1)

Meir General Hospital; 🇮🇱 Kfar Saba, Israel