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

Headache, Migraine Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438553
• Other study ID #: NRLF-0086-14-MMC-CTIL
• Status: Completed
• Phase: N/A
• First received: May 3, 2015
• Last updated: January 6, 2016
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: January 2016
• Source: Neurolief Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache, Migraine
• Migraine Disorders

Intervention

Device:
• OSTNS Neurostimulator
Non-invasive transcutaneous neurostimulation.
• Placebo OSTNS Neurostimulator
Placebo non-invasive transcutaneous neurostimulation

Locations

Country	Name	City	State
Israel	Meir General Hospital	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Neurolief Ltd.

Country where clinical trial is conducted

Israel, 

References & Publications (9)

Ahmed HE, White PF, Craig WF, Hamza MA, Ghoname ES, Gajraj NM. Use of percutaneous electrical nerve stimulation (PENS) in the short-term management of headache. Headache. 2000 Apr;40(4):311-5. — View Citation

Hann S, Sharan A. Dual occipital and supraorbital nerve stimulation for chronic migraine: a single-center experience, review of literature, and surgical considerations. Neurosurg Focus. 2013 Sep;35(3):E9. doi: 10.3171/2013.6.FOCUS13233. Review. — View Citation

Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. — View Citation

Loder E. Triptan therapy in migraine. N Engl J Med. 2010 Jul 1;363(1):63-70. doi: 10.1056/NEJMct0910887. Review. — View Citation

Saper JR, Dodick DW, Silberstein SD, McCarville S, Sun M, Goadsby PJ; ONSTIM Investigators. Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study. Cephalalgia. 2011 Feb;31(3):271-85. doi: 10.1177/0333102410381142. Epub 2010 Sep 22. — View Citation

Schoenen J, Vandersmissen B, Jeangette S, Herroelen L, Vandenheede M, Gérard P, Magis D. Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial. Neurology. 2013 Feb 19;80(8):697-704. doi: 10.1212/WNL.0b013e3182825055. Epub 2013 Feb 6. — View Citation

Schwedt TJ. Occipital nerve stimulation for chronic migraine--interpreting the ONSTIM feasibility trial. Cephalalgia. 2011 Feb;31(3):262-3. doi: 10.1177/0333102410383591. Epub 2010 Sep 16. — View Citation

Silberstein SD, Dodick DW, Saper J, Huh B, Slavin KV, Sharan A, Reed K, Narouze S, Mogilner A, Goldstein J, Trentman T, Vaisman J, Ordia J, Weber P, Deer T, Levy R, Diaz RL, Washburn SN, Mekhail N. Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: results from a randomized, multicenter, double-blinded, controlled study. Cephalalgia. 2012 Dec;32(16):1165-79. doi: 10.1177/0333102412462642. Epub 2012 Oct 3. Erratum in: Cephalalgia. 2014 Oct;34(11):944. Vaisma, Julien [corrected to Vaisman, Julien]. — View Citation

Tfelt-Hansen P, Pascual J, Ramadan N, Dahlöf C, D'Amico D, Diener HC, Hansen JM, Lanteri-Minet M, Loder E, McCrory D, Plancade S, Schwedt T; International Headache Society Clinical Trials Subcommittee. Guidelines for controlled trials of drugs in migraine — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	"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.	No
Secondary	"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	No
Secondary	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	No
Secondary	"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	No
Secondary	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	No
Secondary	Pain free at 2 hours	Percentage of subjects that are pain free at 2 hours	Baseline, 2 hours	No
Secondary	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	No
Secondary	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	No
Secondary	Time until use of pain relief medication.	Time until use of pain relief medication.	Baseline- 24 hours.	No
Secondary	Presence of nausea, vomiting, photophobia, phonophobia.	Presence of nausea, vomiting, photophobia, phonophobia.	Baseline- 24 hours.	No
Secondary	Percentage of subjects who completed the treatment.	Percentage of subjects who completed at least 20 minutes the treatment.	Baseline-20 minutes of treatment	No
Secondary	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.	No