Clinical trial NCT02438553: Short-term Effectiveness of Transcutaneous Nerve Stimulation in Reducing Migraine Related Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache, Migraine
Lead sponsor: Neurolief Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain visual analogue scale (VAS)
timeFrame: 20-60 minutes of treatment.
Secondary outcomes:
measure: "Responder" rate at 20-60 minutes of treatment.
timeFrame: 20-60 minutes of treatment.
measure: "Responder" rate at 15 minutes of treatment
timeFrame: Baseline, 15 minutes of treatment
measure: Sustained "Responder" rate at 24 hours post treatment
timeFrame: Baseline, 24 hours post treatment
measure: "Headache relief" rate- at 2 hours
timeFrame: Baseline, 2 hours
measure: Sustained "headache relief" at 24 hours
timeFrame: Baseline, 24 hours
measure: Pain free at 2 hours
timeFrame: Baseline, 2 hours
measure: Sustained pain freedom at 24 hours
timeFrame: Baseline, 24 hours
measure: Functional disability change 2 hours from end of treatment
timeFrame: Baseline, 2 Hours post treatment
measure: Time until use of pain relief medication.
timeFrame: Baseline- 24 hours.
measure: Presence of nausea, vomiting, photophobia, phonophobia.
timeFrame: Baseline- 24 hours.
measure: Percentage of subjects who completed the treatment.
timeFrame: Baseline-20 minutes of treatment
measure: Global impression of effect
timeFrame: Baseline- 24 hours.
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir General Hospital
Study officials:
affiliation: Director of headache clinic, Department of Neurology, Meir General Hospital, Kfar Saba, Israel.
name: Rachel Hering, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1212/01.wnl.0000252808.97649.21.
citation: 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. doi: 10.1046/j.1526-4610.2000.00046.x.
citation: Loder E. Triptan therapy in migraine. N Engl J Med. 2010 Jul 1;363(1):63-70. doi: 10.1056/NEJMct0910887. No abstract available.
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.
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.
citation: Schoenen J, Vandersmissen B, Jeangette S, Herroelen L, Vandenheede M, Gerard 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.
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. No abstract available.
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.
citation: Tfelt-Hansen P, Pascual J, Ramadan N, Dahlof 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: third edition. A guide for investigators. Cephalalgia. 2012 Jan;32(1):6-38. doi: 10.1177/0333102411417901. No abstract available.