Utilization of 60-Day Peripheral Nerve Stimulation of the Occipital Nerves for the Treatment of Headache

Utilization of 60-Day Peripheral Nerve Stimulation of the Occipital Nerves for the Treatment of Headache: A Prospective Multisite Cohort Study of Health Care Resource Utilization and Clinical Outcomes

This prospective observational cohort study will evaluate clinical outcomes and health care resource utilization among adults who, independent of research participation, are clinically scheduled to undergo temporary 60-day occipital nerve peripheral nerve stimulation (PNS) as part of routine care for refractory headache disorders.

The main purpose of this prospective observational cohort study is to evaluate clinical outcomes and health care resource utilization among adults who, independent of research participation, are clinically scheduled to undergo temporary 60-day occipital nerve peripheral nerve stimulation (PNS) as part of routine care for refractory headache disorders.

The study will assess changes in headache impact, pain intensity, neck-related disability, patient global impression of change, medication utilization, and headache-related health care utilization over 12 months. The anticipated impact of this research is improved understanding of whether occipital PNS delivered in standard clinical practice is associated with better patient-reported outcomes, fewer acute care visits, and lower utilization of health system resources, which may ultimately inform clinical decision-making, quality-of-life improvement, and potential cost savings.

Planned analyses include within-subject longitudinal comparisons from baseline to 60 days and 12 months, site adjusted modeling of utilization outcomes, and exploratory analyses of predictors of response across headache diagnoses and patient subgroups.

Inclusion Criteria:

• Diagnosis of a headache disorder for which the treating clinician has independently made the clinical decision to proceed with temporary 60-day occipital nerve PNS as part of routine care, including:
• Occipital neuralgia
• Chronic migraine
• Chronic tension-type headache
• Chronic cluster headache
• Cervicogenic headache
• Clinically scheduled to undergo temporary 60-day occipital PNS as part of routine care.
• Ability to provide informed consent.

Exclusion Criteria:

• Inability to provide informed consent.
• Coagulopathy that would prohibit PNS placement.
• Severe psychiatric illness interfering with participation.