Treatment for Migraines With an Implantable Device

A study testing Precision in people with Migraine, run by Boston Scientific Corporation at 15 sites in United States.

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 safety and effectiveness of an implantable device for difficult to treat migraine. There are a significant number of patients who have drug refractory migraine and alternative therapies are needed. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Migraine
What is being tested?: Precision
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 179 participants
Where: 15 sitesUnited States
Study dates: Feb 2006to 7 Nov 2018
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be diagnosed with multiple migraines per month of moderate to severe intensity;
Be refractory to medication;
Be an appropriate candidate for the surgical procedures required for this study;
Be willing and able to comply with all study related procedures;
Be capable of reading and understanding patient information materials and giving written informed consent.

Who cannot join

Have onset of migraine after age 50;
Have a significant psychiatric disorder;
Have previously been treated with occipital nerve stimulation;
Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment;
Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radio frequency procedure currently in effect;
Have a condition currently requiring or likely to require the use of MRI or diathermy;
Have an active implantable device;
Have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Walton Rehabilitation Hospital
Augusta, Georgia, 30901
Rush Pain Center
Chicago, Illinois, 60612
Diamond Headache Clinic
Chicago, Illinois, 60614
Mile High Research Center
Denver, Colorado, 80218
Research Center
Fort Worth, Texas, 76162
Headache Specialists
Las Vegas, Nevada, 89109
Nashville Neuroscience Group
Nashville, Tennessee, 37203
Thomas Jefferson University - Jefferson Headache
Philadelphia, Pennsylvania, 19107
The Neurological Clinic
Portland, Oregon, 97210
Lifetree Clinical Research
Salt Lake City, Utah, 84106
Swedish Pain & Headache Center
Seattle, Washington, 98104
Headache Care Center
Springfield, Missouri, 65807
The New England Center for Headache
Stamford, Connecticut, 06902
Albert Einstein College of Medicine - Montefiore Headache Unit
The Bronx, New York, 10461
New England Regional Headache Center
Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine

Conditions: Migraine
Being tested: Precision
Keywords: Headache, Migraine, Refractory, Chronic, Pain
Medical subject headings: Migraine Disorders, Headache, Bronchiolitis Obliterans Syndrome, Pain

What participants receive

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

PrecisionDevice
Implantable neurostimulator

Study groups in NCT00286078
Study group	Role	What they receive
Treatment	Experimental	Active occipital nerve stimulation (stimulation on) Receives: Device: Precision
Control	Sham comparator	Sham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on. Receives: Device: Precision

What is being measured

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

Migraine Frequency at 12 Weeks
Change from baseline in migraine days/month at 12 weeks
Measured: Baseline and 12 weeks
Frequency of Adverse Event
Cumulative frequency of adverse events from randomization to 26 weeks
Measured: 26 weeks

Timeline

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

Feb 20067 Nov 2018

First posted3 Feb 2006 (estimated)
Study startFeb 2006
Primary completionApr 2009
Study completion7 Nov 2018

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 MigraineStudies 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: 179 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00286078
Sponsor's protocol ID: EI0105
Status last verified: Jul 2019
First submitted: 1 Feb 2006
Last updated: 30 Jul 2019
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

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Precision Implantable Stimulator for Migraine (PRISM) Study- Occipital Nerve Stimulation (ONS) for Migraine
ClinicalTrials.gov ID: NCT00286078
Acronym / sponsor ID: EI0105
Conditions: Migraine
Keywords: Headache, Migraine, Refractory, Chronic, Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 179 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Apr 2009 (actual)
Study completion: 7 Nov 2018 (actual)
First posted: 3 Feb 2006 (estimated)
Results: Posted 9 Aug 2016

Clinical summary

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

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: PrecisionActive occipital nerve stimulation (stimulation on)
Control	Sham comparator	Device: PrecisionSham occipital nerve stimulation from activation to 12 weeks post-activation. Active occipital nerve stimulation from 12 weeks post-activation on.

Who may qualify

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

Key inclusion criteria (5 listed)

Be diagnosed with multiple migraines per month of moderate to severe intensity;
Be refractory to medication;
Be an appropriate candidate for the surgical procedures required for this study;
Be willing and able to comply with all study related procedures;
Be capable of reading and understanding patient information materials and giving written informed consent.

Key exclusion criteria (8 listed)

Have onset of migraine after age 50;
Have a significant psychiatric disorder;
Have previously been treated with occipital nerve stimulation;
Have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment;
Have previously undergone destructive ganglionectomy affecting C2/C3 occipital and/or trigeminal distribution or have an occipital blockade or radio frequency procedure currently in effect;

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
PrecisionImplantable neurostimulator	Device	Control, Treatment

Primary outcome

Migraine Frequency at 12 Weeks
Time frame: Baseline and 12 weeks
Change from baseline in migraine days/month at 12 weeks
Frequency of Adverse Event
Time frame: 26 weeks
Cumulative frequency of adverse events from randomization to 26 weeks

Results and safety

Results posted to the registry on 9 Aug 2016, 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	72	40
Control	68	34

Primary outcome: Migraine Frequency at 12 Weeks

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: days

Measure	Treatment n = 63	Control n = 62
Value	-5.5 (8.7)	-3.9 (8.2)

Population analysed: Modified Intent to Treat

Primary outcome: Frequency of Adverse Event

Time frame: 26 weeks. Number. Unit: events

Measure	Treatment n = 71	Control n = 68
Value	276	284

Adverse events

Time frame: Safety data was collected through the 12 year follow up visit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	33 of 72 (45.8%)	68 of 72 (94.4%)	Not reported
Control	19 of 68 (27.9%)	63 of 68 (92.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Migraine

RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)

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

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

Questions about this trial

What is this clinical trial studying?

A study testing Precision in people with Migraine, run by Boston Scientific Corporation at 15 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 5 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: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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. 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?

Yes. Results are posted in the registry (first posted 9 Aug 2016). 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?

Migraine Frequency at 12 Weeks (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. 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 NCT00286078.

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 30 Jul 2019.