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

Primary Purpose

Headache, Migraine

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
OSTNS Neurostimulator
Placebo OSTNS Neurostimulator
Sponsored by
Neurolief Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache, Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Meir General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

OSTNS Neurostimulator

Placebo OSTNS Neurostimulator

Arm Description

Combined Occipital & Supraorbital Transcutaneous Neurostimulator.

Placebo Combined Occipital & Supraorbital Transcutaneous Neurostimulator.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

"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.
"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.
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.
"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.
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.
Pain free at 2 hours
Percentage of subjects that are pain free at 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.
Functional disability change 2 hours from end of treatment
Functional disability change 2 hours from end of treatment without using pain relief medication.
Time until use of pain relief medication.
Time until use of pain relief medication.
Presence of nausea, vomiting, photophobia, phonophobia.
Presence of nausea, vomiting, photophobia, phonophobia.
Percentage of subjects who completed the treatment.
Percentage of subjects who completed at least 20 minutes the treatment.
Global impression of effect
Global impression of effect- A simple Likert-type verbal scale: very poor, poor, no opinion, good, very good.

Full Information

First Posted
May 3, 2015
Last Updated
January 6, 2016
Sponsor
Neurolief Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02438553
Brief Title
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurolief Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OSTNS Neurostimulator
Arm Type
Experimental
Arm Description
Combined Occipital & Supraorbital Transcutaneous Neurostimulator.
Arm Title
Placebo OSTNS Neurostimulator
Arm Type
Placebo Comparator
Arm Description
Placebo Combined Occipital & Supraorbital Transcutaneous Neurostimulator.
Intervention Type
Device
Intervention Name(s)
OSTNS Neurostimulator
Other Intervention Name(s)
Transcutaneous Neurostimulator.
Intervention Description
Non-invasive transcutaneous neurostimulation.
Intervention Type
Device
Intervention Name(s)
Placebo OSTNS Neurostimulator
Other Intervention Name(s)
Transcutaneous Neurostimulator
Intervention Description
Placebo non-invasive transcutaneous neurostimulation
Primary Outcome Measure Information:
Title
Pain visual analogue scale (VAS)
Description
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.
Time Frame
20-60 minutes of treatment.
Secondary Outcome Measure Information:
Title
"Responder" rate at 20-60 minutes of treatment.
Description
- 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.
Time Frame
20-60 minutes of treatment.
Title
"Responder" rate at 15 minutes of treatment
Description
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.
Time Frame
Baseline, 15 minutes of treatment
Title
Sustained "Responder" rate at 24 hours post treatment
Description
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.
Time Frame
Baseline, 24 hours post treatment
Title
"Headache relief" rate- at 2 hours
Description
"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.
Time Frame
Baseline, 2 hours
Title
Sustained "headache relief" at 24 hours
Description
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.
Time Frame
Baseline, 24 hours
Title
Pain free at 2 hours
Description
Percentage of subjects that are pain free at 2 hours
Time Frame
Baseline, 2 hours
Title
Sustained pain freedom at 24 hours
Description
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.
Time Frame
Baseline, 24 hours
Title
Functional disability change 2 hours from end of treatment
Description
Functional disability change 2 hours from end of treatment without using pain relief medication.
Time Frame
Baseline, 2 Hours post treatment
Title
Time until use of pain relief medication.
Description
Time until use of pain relief medication.
Time Frame
Baseline- 24 hours.
Title
Presence of nausea, vomiting, photophobia, phonophobia.
Description
Presence of nausea, vomiting, photophobia, phonophobia.
Time Frame
Baseline- 24 hours.
Title
Percentage of subjects who completed the treatment.
Description
Percentage of subjects who completed at least 20 minutes the treatment.
Time Frame
Baseline-20 minutes of treatment
Title
Global impression of effect
Description
Global impression of effect- A simple Likert-type verbal scale: very poor, poor, no opinion, good, very good.
Time Frame
Baseline- 24 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Hering, Dr.
Organizational Affiliation
Director of headache clinic, Department of Neurology, Meir General Hospital, Kfar Saba, Israel.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meir General Hospital
City
Kfar Saba
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
17261680
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.
Results Reference
background
PubMed Identifier
10759936
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.
Results Reference
background
PubMed Identifier
20592298
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.
Results Reference
background
PubMed Identifier
23991822
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.
Results Reference
background
PubMed Identifier
20861241
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.
Results Reference
background
PubMed Identifier
23390177
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.
Results Reference
background
PubMed Identifier
20847083
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.
Results Reference
background
PubMed Identifier
23034698
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]. Cephalalgia. 2014 Oct;34(11):944.
Results Reference
background
PubMed Identifier
22384463
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.
Results Reference
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Short-term Effectiveness of Transcutaneous Nerve Stimulation in Reducing Migraine Related Pain

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