Migraine DisordersOPTIMISENCT01775735

Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE

A study testing Occipital nerve stimulator in people with Migraine Disorders, run by Boston Scientific Corporation at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The primary objective of this study is to evaluate the safety and efficacy of occipital nerve stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in the management of intractable chronic migraine, when used in conjunction with anti-migraine medications. Read more about this study

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Migraine Disorders
What is being tested?: Occipital nerve stimulator
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 10 sitesUnited States
Study dates: 10 Apr 2013to 19 Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Onset of chronic migraine at least 6 months prior to start of Screening determined by a well-documented history
Evidence of intractability
Posterior-dominant head pain
Stable pattern of headache symptoms for at least 6 months prior to the beginning of Screening
Onset of migraine before the age of 50
If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test

Who cannot join

Diagnosed with any major psychiatric disorder not specifically listed in Key Exclusion Criteria 2-4 (e.g. multiple personality disorder, schizophrenia)
Untreated panic disorder
Untreated major depression evidenced by a PHQ-9 score >20
Untreated generalized anxiety disorder evidenced by a GAD-7 score ≥15
Currently diagnosed with severe personality disorder
A female of childbearing potential planning to get pregnant during the course of the study or not using adequate contraception
Participating in another drug, device, or biologics trial within 3 months prior to Screening
A terminal illness associated with survival <24 months

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

University of Illinois at Chicago (Implanting Physician)
Chicago, Illinois, 60612
Diamond Headache Clinic (Headache Physician)
Chicago, Illinois, 60642
Henry Ford Hospital (Headache Physician)
Detroit, Michigan, 48202
NYU Medical Center (Implanting Physician)
New York, New York, 10016
Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician)
Shreveport, Louisiana, 71105
Mercy Pain Management -Surgery Center (Implanting Physician)
Springfield, Missouri, 65804
Clinvest Research, LLC (Headache Physician)
Springfield, Missouri, 65807
Montefiore Headache Center (Headache Physician)
The Bronx, New York, 10461
Boston Scientific Clinical Research Information Toll Free Number
Valencia, California, 91355
Henry Ford Medical Group (Implanting Physician)
West Bloomfield, Michigan, 48322

Other trials in United States

About this study

Official title: Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE

Read the detailed description

Initial reports of managing migraine headache with ONS described a technique in which electrical leads were implanted in the subcutaneous space transverse to the occipital nerve, in the back of the head, under x-ray guidance. The leads were tunneled under the skin to an implantable pulse generator (IPG) implanted in the chest wall or abdomen. The OPTIMISE Trial is designed to be a pivotal study of the Boston Scientific PRECISION neurostimulation system, when the system is used for ONS. The PRECISION System has been previously been approved for Spinal Cord Stimulation (SCS).

Conditions: Migraine Disorders
Being tested: Occipital nerve stimulator
Keywords: headache, pain, chronic
Medical subject headings: Migraine Disorders, Headache, Pain, Bronchiolitis Obliterans Syndrome

What participants receive

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

Occipital nerve stimulatorDevice
Also called Boston Scientific Precision System
Electrical stimulation of the greater occipital nerve

Study groups in NCT01775735
Study group	Role	What they receive
Treatment	Experimental	The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization Receives: Device: Occipital nerve stimulator
Control	Active comparator	The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization Receives: Device: Occipital nerve stimulator

What is being measured

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

Change in the Number of Moderate-to-severe Headache Days Per Month
A moderate-to-severe headache day will be defined as any calendar day with:
1. headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity OR
2. a subject taking a triptan or ergot, regardless of headache pain duration or severity
The Baseline number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the first 30 calendar days of eDiary entries if the eDiary contained ≥70% of data. The 6 months post-randomization number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit if the eDiary contained ≥70% of data.
Measured: from Baseline to 6 months post-randomization

Timeline

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

10 Apr 201319 Jan 2017

First posted25 Jan 2013 (estimated)
Study start10 Apr 2013
Primary completion1 Dec 2015
Study completion19 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Migraine DisordersStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01775735
Sponsor's protocol ID: G120051
Other IDs: CDM00046436
Acronym: OPTIMISE
Status last verified: Nov 2020
First submitted: 23 Jan 2013
Last updated: 13 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Migraine Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE
ClinicalTrials.gov ID: NCT01775735
Acronym / sponsor ID: OPTIMISE / G120051
Conditions: Migraine Disorders
Keywords: headache, pain, chronic
Study type: Interventional
Recruitment status: Terminated
Enrolment: 28 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: 10 Apr 2013 (actual)
Primary completion: 1 Dec 2015 (actual)
Study completion: 19 Jan 2017 (actual)
First posted: 25 Jan 2013 (estimated)
Results: Posted 2 Nov 2018

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Treatment	Experimental	Device: Occipital nerve stimulatorThe treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization
Control	Active comparator	Device: Occipital nerve stimulatorThe control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Onset of chronic migraine at least 6 months prior to start of Screening determined by a well-documented history
Evidence of intractability
Posterior-dominant head pain
Stable pattern of headache symptoms for at least 6 months prior to the beginning of Screening
Onset of migraine before the age of 50

Key exclusion criteria (8 listed)

Diagnosed with any major psychiatric disorder not specifically listed in Key Exclusion Criteria 2-4 (e.g. multiple personality disorder, schizophrenia)
Untreated panic disorder
Untreated major depression evidenced by a PHQ-9 score >20
Untreated generalized anxiety disorder evidenced by a GAD-7 score ≥15
Currently diagnosed with severe personality disorder

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
Occipital nerve stimulatorAlso: Boston Scientific Precision SystemElectrical stimulation of the greater occipital nerve	Device	Control, Treatment

Primary outcome

Change in the Number of Moderate-to-severe Headache Days Per Month
Time frame: from Baseline to 6 months post-randomization
A moderate-to-severe headache day will be defined as any calendar day with: 1. headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity OR 2. a subject taking a triptan or ergot, regardless of headache pain duration or severity The Baseline number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the first 30 calendar days of eDiary entries if the eDiary contained ≥70% of data. The 6 months post-randomization number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit if the eDiary contained ≥70% of data.

Results and safety

Results posted to the registry on 2 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	8	8
Control	7	7

Primary outcome: Change in the Number of Moderate-to-severe Headache Days Per Month

Time frame: from Baseline to 6 months post-randomization. Median (Standard Deviation). Unit: days

Measure	Treatment n = 4	Control n = 6
Value	-5.2 (7.3)	0 (10.8)

Population analysed: All subjects who completed Baseline and 6 months post-randomization and had ≥70% of eDiary data. Data for 5 subjects was not calculated due to missing eDiary data. Statistical analysis was not performed as the sample size is too small to draw any statistically relevant conclusions.

Adverse events

Time frame: Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	4 of 8 (50%)	3 of 8 (37.5%)	0 of 8
Control	1 of 7 (14.3%)	3 of 7 (42.9%)	0 of 7

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects analyzed. Statistical analysis was not performed as the sample size was too small to draw any statistically relevant conclusions.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Richard Lipton, MD principal investigator

Albert Einstein College of Medicine

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

Questions about this trial

What is this clinical trial studying?

A study testing Occipital nerve stimulator in people with Migraine Disorders, run by Boston Scientific Corporation at 10 sites in United States.

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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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. 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?

Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in the Number of Moderate-to-severe Headache Days Per Month (time frame: from Baseline to 6 months post-randomization). 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 NCT01775735.

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 13 Nov 2020.