Short-term Effectiveness of Transcutaneous Nerve Stimulation in Reducing Migraine Related Pain
NCT ID: NCT02438553
Last Updated: 2016-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2015-05-31
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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OSTNS Neurostimulator
Combined Occipital \& Supraorbital Transcutaneous Neurostimulator.
OSTNS Neurostimulator
Non-invasive transcutaneous neurostimulation.
Placebo OSTNS Neurostimulator
Placebo Combined Occipital \& Supraorbital Transcutaneous Neurostimulator.
Placebo OSTNS Neurostimulator
Placebo non-invasive transcutaneous neurostimulation
Interventions
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OSTNS Neurostimulator
Non-invasive transcutaneous neurostimulation.
Placebo OSTNS Neurostimulator
Placebo non-invasive transcutaneous neurostimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Neurolief Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Rachel Hering, Dr.
Role: PRINCIPAL_INVESTIGATOR
Director of headache clinic, Department of Neurology, Meir General Hospital, Kfar Saba, Israel.
Locations
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Meir General Hospital
Kfar Saba, , Israel
Countries
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References
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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.
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.
Loder E. Triptan therapy in migraine. N Engl J Med. 2010 Jul 1;363(1):63-70. doi: 10.1056/NEJMct0910887. No abstract available.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NRLF-0086-14-MMC-CTIL
Identifier Type: -
Identifier Source: org_study_id
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