Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE

Migraine Disorders Clinical Trial

— OPTIMISE  

Official title:

Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01775735
• Other study ID #: G120051
• Secondary ID: CDM00046436
• Status: Terminated
• Phase: N/A
• Start date: April 10, 2013
• Est. completion date: January 19, 2017

Study information

• Verified date: November 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: January 19, 2017
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine Disorders

Intervention

Device:
• Occipital nerve stimulator
Electrical stimulation of the greater occipital nerve

Locations

Country	Name	City	State
United States	Montefiore Headache Center (Headache Physician)	Bronx	New York
United States	Diamond Headache Clinic (Headache Physician)	Chicago	Illinois
United States	University of Illinois at Chicago (Implanting Physician)	Chicago	Illinois
United States	Henry Ford Hospital (Headache Physician)	Detroit	Michigan
United States	NYU Medical Center (Implanting Physician)	New York	New York
United States	Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician)	Shreveport	Louisiana
United States	Clinvest Research, LLC (Headache Physician)	Springfield	Missouri
United States	Mercy Pain Management -Surgery Center (Implanting Physician)	Springfield	Missouri
United States	Boston Scientific Clinical Research Information Toll Free Number	Valencia	California
United States	Henry Ford Medical Group (Implanting Physician)	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: headache pain that lasts =4 hours AND peak severity of moderate or severe intensity; OR; 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.	from Baseline to 6 months post-randomization