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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSTNS Neurostimulator | Experimental | Combined Occipital & Supraorbital Transcutaneous Neurostimulator. |
|
| Placebo OSTNS Neurostimulator | Placebo Comparator | Placebo Combined Occipital & Supraorbital Transcutaneous Neurostimulator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSTNS Neurostimulator | Device | Non-invasive transcutaneous neurostimulation. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rachel Hering, Dr. | Director of headache clinic, Department of Neurology, Meir General Hospital, Kfar Saba, Israel. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir General Hospital | Kfar Saba | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17261680 | Background | 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. | |
| 10759936 | Background | 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. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo OSTNS Neurostimulator | Device | Placebo non-invasive transcutaneous neurostimulation |
|
|
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. |
| 20592298 | Background | Loder E. Triptan therapy in migraine. N Engl J Med. 2010 Jul 1;363(1):63-70. doi: 10.1056/NEJMct0910887. No abstract available. |
| 23991822 | Background | 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. |
| 20861241 | Background | 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. |
| 23390177 | Background | 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. |
| 20847083 | Background | 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. |
| 23034698 | Background | 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. |
| 22384463 | Result | 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. |
| D009422 | Nervous System Diseases |