Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE

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).

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