Clinical trial NCT01775735: Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE
Official title: Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Migraine Disorders
Keywords: headache
pain
chronic
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2013-01-25
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in the Number of Moderate-to-severe Headache Days Per Month
timeFrame: from Baseline to 6 months post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: United States
facility: Boston Scientific Clinical Research Information Toll Free Number
state: California
city: Chicago
country: United States
facility: University of Illinois at Chicago (Implanting Physician)
state: Illinois
city: Chicago
country: United States
facility: Diamond Headache Clinic (Headache Physician)
state: Illinois
city: Shreveport
country: United States
facility: Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician)
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Hospital (Headache Physician)
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford Medical Group (Implanting Physician)
state: Michigan
city: Springfield
country: United States
facility: Mercy Pain Management -Surgery Center (Implanting Physician)
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research, LLC (Headache Physician)
state: Missouri
city: Bronx
country: United States
facility: Montefiore Headache Center (Headache Physician)
state: New York
city: New York
country: United States
facility: NYU Medical Center (Implanting Physician)
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Richard Lipton, MD
role: PRINCIPAL_INVESTIGATOR
References: