CompletedNCT00286078Updated Jul 30, 2019Results posted

Treatment for Migraines With an Implantable Device

An interventional study of Precision in Migraine, sponsored by Boston Scientific Corporation. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 179
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Migraine

Browse trials for

Migraine Disorders 1,528

Keywords

Headache
Migraine
Refractory
Chronic
Pain

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 179 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key Inclusion Criteria:

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:

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 179 participants (actual)

Study arms

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

Interventions

DevicePrecision
Implantable neurostimulator

What researchers measure

Primary outcomes

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

Results

Posted Aug 9, 2016

Participant flow

Participant flow — Overall Study
Milestone	Treatment	Control
Started	72	68
12 weeks	63	62
Completed	40	34
Not completed	32	34

Outcome measures

PrimaryMigraine Frequency at 12 Weeks

Change from baseline in migraine days/month at 12 weeks

Time frame:: Baseline and 12 weeks
Reported as:: Mean · days

Migraine Frequency at 12 Weeks
days	Treatment	Control
Migraine Frequency at 12 Weeks	-5.5 ± 8.7	-3.9 ± 8.2

PrimaryFrequency of Adverse Event

Cumulative frequency of adverse events from randomization to 26 weeks

Time frame:: 26 weeks
Reported as:: Number · events

Frequency of Adverse Event
events	Treatment	Control
Frequency of Adverse Event	276	284

Adverse events

Collected over Safety data was collected through the 12 year follow up visit.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment	—	33/72 (45.8%)	68/72 (94.4%)
Control	—	19/68 (27.9%)	63/68 (92.6%)

Most frequent serious events

Showing 10 of 74

Most frequent serious events
Event	Treatment	Control
MigraineNervous system disorders	6/72	2/68
HeadacheNervous system disorders	3/72	0/68
Device related infectionInfections and infestations	1/72	2/68
Drug ToxicityInjury, poisoning and procedural complications	2/72	0/68
HypotensionVascular disorders	2/72	0/68
Bacterial InfectionInfections and infestations	0/72	1/68
Wound infectionInfections and infestations	0/72	1/68
Wrist fractureInjury, poisoning and procedural complications	0/72	1/68
Suicide attemptPsychiatric disorders	0/72	1/68
Respiratory arrestRespiratory, thoracic and mediastinal disorders	0/72	1/68

Most frequent other events

Showing 10 of 28

Most frequent other events
Event	Treatment	Control
Therapeutic product ineffectiveGeneral disorders	46/72	44/68
Inappropriate device stimulation of tissueInjury, poisoning and procedural complications	24/72	9/68
Implant site painGeneral disorders	10/72	16/68
NauseaGastrointestinal disorders	16/72	9/68
HeadacheNervous system disorders	14/72	9/68
MigraineNervous system disorders	6/72	11/68
SinusitisInfections and infestations	7/72	10/68
Neck painMusculoskeletal and connective tissue disorders	6/72	10/68
Incision site painInjury, poisoning and procedural complications	5/72	8/68
Back painMusculoskeletal and connective tissue disorders	8/72	8/68

Baseline characteristics

1 subject excluded from analysis because HIPAA authorization was not obtained; randomized to active group, received percutaneous trial only

Age, Continuous
Age, Continuous(years)	Treatment	Control	Total
Mean	41.5 ± 11.2	43.8 ± 11.9	42.6 ± 11.6

Sex: Female, Male
Sex: Female, Male(Participants)	Treatment	Control	Total
Female	60	57	117
Male	11	11	22

Region of Enrollment
Region of Enrollment(participants)	Treatment	Control	Total
United States	71	68	139

Study locations

15 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00286078
Lead sponsor: Boston Scientific Corporation
Responsible party: Sponsor
First posted: Feb 3, 2006
Start date: Feb 2006
Primary completion: Apr 2009
Completion: Nov 7, 2018
Results posted: Aug 9, 2016
Last update: Jul 30, 2019

Study contacts

Richard Lipton, MD

principal investigator · Albert Einstein College of Medicine

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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