Headache, MigraineNCT02438553

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

A study testing OSTNS Neurostimulator in people with Headache, Migraine, run by Neurolief Ltd. at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Headache, Migraine
What is being tested?: OSTNS Neurostimulator
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteIsrael
Study dates: May 2015to Oct 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 12Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

Meir General Hospital
Kfar Saba

Other trials in Israel

About this study

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

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.

Conditions: Headache, Migraine
Being tested: OSTNS Neurostimulator, Placebo OSTNS Neurostimulator
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OSTNS NeurostimulatorDevice
Also called Transcutaneous Neurostimulator.
Non-invasive transcutaneous neurostimulation.
Placebo OSTNS NeurostimulatorDevice
Also called Transcutaneous Neurostimulator
Placebo non-invasive transcutaneous neurostimulation

Study groups in NCT02438553
Study group	Role	What they receive
OSTNS Neurostimulator	Experimental	Combined Occipital \& Supraorbital Transcutaneous Neurostimulator. Receives: Device: OSTNS Neurostimulator
Placebo OSTNS Neurostimulator	Placebo comparator	Placebo Combined Occipital \& Supraorbital Transcutaneous Neurostimulator. Receives: Device: Placebo OSTNS Neurostimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 20-60 minutes of treatment.

Secondary outcomes (12)

"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.
Measured: 20-60 minutes of treatment.
"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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 24 hours
Pain free at 2 hours
Percentage of subjects that are pain free at 2 hours
Measured: 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.
Measured: 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.
Measured: Baseline, 2 Hours post treatment
Time until use of pain relief medication.
Time until use of pain relief medication.
Measured: Baseline- 24 hours.
Presence of nausea, vomiting, photophobia, phonophobia.
Presence of nausea, vomiting, photophobia, phonophobia.
Measured: Baseline- 24 hours.
Percentage of subjects who completed the treatment.
Percentage of subjects who completed at least 20 minutes the treatment.
Measured: 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.
Measured: Baseline- 24 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Oct 2015

First posted8 May 2015 (estimated)
Study startMay 2015
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Headache, MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02438553
Sponsor's protocol ID: NRLF-0086-14-MMC-CTIL
Status last verified: Jan 2016
First submitted: 3 May 2015
Last updated: 7 Jan 2016
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 17261680
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.
PubMed 10759936
Loder E. Triptan therapy in migraine. N Engl J Med. 2010 Jul 1;363(1):63-70. doi: 10.1056/NEJMct0910887. No abstract available.
PubMed 20592298
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.
PubMed 23991822
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.
PubMed 20861241
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.
PubMed 23390177
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.
PubMed 20847083
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.
PubMed 23034698
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.
PubMed 22384463

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of the Glymphatic System in Migraine
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Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
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App-Based Migraine Treatment: The Health enSuite Study
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A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
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All Headache, Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02438553
Acronym / sponsor ID: NRLF-0086-14-MMC-CTIL
Conditions: Headache, Migraine
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Neurolief Ltd.Industry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 8 May 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
OSTNS Neurostimulator	Experimental	Device: OSTNS NeurostimulatorCombined Occipital \& Supraorbital Transcutaneous Neurostimulator.
Placebo OSTNS Neurostimulator	Placebo comparator	Device: Placebo OSTNS NeurostimulatorPlacebo Combined Occipital \& Supraorbital Transcutaneous Neurostimulator.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OSTNS NeurostimulatorAlso: Transcutaneous Neurostimulator.Non-invasive transcutaneous neurostimulation.	Device	OSTNS Neurostimulator
Placebo OSTNS NeurostimulatorAlso: Transcutaneous NeurostimulatorPlacebo non-invasive transcutaneous neurostimulation	Device	Placebo OSTNS Neurostimulator

Primary outcome

Pain visual analogue scale (VAS)
Time frame: 20-60 minutes of treatment.
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.

12 secondary outcomes

"Responder" rate at 20-60 minutes of treatment.
Time frame: 20-60 minutes of treatment.
"Responder" rate at 15 minutes of treatment
Time frame: Baseline, 15 minutes of treatment
Sustained "Responder" rate at 24 hours post treatment
Time frame: Baseline, 24 hours post treatment
"Headache relief" rate- at 2 hours
Time frame: Baseline, 2 hours
Sustained "headache relief" at 24 hours
Time frame: Baseline, 24 hours
Pain free at 2 hours
Time frame: Baseline, 2 hours
Sustained pain freedom at 24 hours
Time frame: Baseline, 24 hours
Functional disability change 2 hours from end of treatment
Time frame: Baseline, 2 Hours post treatment
Time until use of pain relief medication.
Time frame: Baseline- 24 hours.
Presence of nausea, vomiting, photophobia, phonophobia.
Time frame: Baseline- 24 hours.
Percentage of subjects who completed the treatment.
Time frame: Baseline-20 minutes of treatment
Global impression of effect
Time frame: Baseline- 24 hours.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
Background: PubMed 17261680Lipton 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.
Background: PubMed 10759936Ahmed 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.
Background: PubMed 20592298Loder E. Triptan therapy in migraine. N Engl J Med. 2010 Jul 1;363(1):63-70. doi: 10.1056/NEJMct0910887. No abstract available.
Background: PubMed 23991822Hann 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.
Background: PubMed 20861241Saper 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.
Background: PubMed 23390177Schoenen 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.
Background: PubMed 20847083Schwedt 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.
Background: PubMed 23034698Silberstein 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.
Results publication: PubMed 22384463Tfelt-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rachel Hering, Dr. principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing OSTNS Neurostimulator in people with Headache, Migraine, run by Neurolief Ltd. at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain visual analogue scale (VAS) (time frame: 20-60 minutes of treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02438553, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2016.