NCT02438553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

May 3, 2015

Last Update Submit

January 6, 2016

Conditions

Headache, Migraine

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (12)

  • "Responder" rate at 20-60 minutes of treatment.

    20-60 minutes of treatment.

  • "Responder" rate at 15 minutes of treatment

    Baseline, 15 minutes of treatment

  • Sustained "Responder" rate at 24 hours post treatment

    Baseline, 24 hours post treatment

  • "Headache relief" rate- at 2 hours

    Baseline, 2 hours

  • Sustained "headache relief" at 24 hours

    Baseline, 24 hours

  • +7 more secondary outcomes

Study Arms (2)

OSTNS Neurostimulator

EXPERIMENTAL

Combined Occipital \& Supraorbital Transcutaneous Neurostimulator.

Device: OSTNS Neurostimulator

Placebo OSTNS Neurostimulator

PLACEBO COMPARATOR

Placebo Combined Occipital \& Supraorbital Transcutaneous Neurostimulator.

Device: Placebo OSTNS Neurostimulator

Interventions

OSTNS NeurostimulatorDEVICE

Non-invasive transcutaneous neurostimulation.

Also known as: Transcutaneous Neurostimulator.
OSTNS Neurostimulator
Placebo OSTNS NeurostimulatorDEVICE

Placebo non-invasive transcutaneous neurostimulation

Also known as: Transcutaneous Neurostimulator
Placebo OSTNS Neurostimulator

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir General Hospital

Kfar Saba, Israel

Location

Related Publications (9)

  • 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.

    PMID: 17261680BACKGROUND

  • 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.

    PMID: 10759936BACKGROUND

  • Loder E. Triptan therapy in migraine. N Engl J Med. 2010 Jul 1;363(1):63-70. doi: 10.1056/NEJMct0910887. No abstract available.

    PMID: 20592298BACKGROUND

  • 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.

    PMID: 23991822BACKGROUND

  • 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.

    PMID: 20861241BACKGROUND

  • 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.

    PMID: 23390177BACKGROUND

  • 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.

    PMID: 20847083BACKGROUND

  • 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.

    PMID: 23034698BACKGROUND

  • 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.

    PMID: 22384463RESULT

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Rachel Hering, Dr.

    Director of headache clinic, Department of Neurology, Meir General Hospital, Kfar Saba, Israel.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2015

First Posted

May 8, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 7, 2016

Record last verified: 2016-01

Locations

IL(1)