Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE

Boston Scientific

Status: Terminated

Conditions: Migraine Disorders

Treatments: Device: Occipital nerve stimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01775735

G120051

CDM00046436 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 28 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Treatment

Experimental group

Description:

The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization

Treatment:

Device: Occipital nerve stimulator

Control

Active Comparator group

Description:

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

Treatment:

Device: Occipital nerve stimulator