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.

Study Overview

• Status: Not yet recruiting
• Conditions: Headache
• Intervention / Treatment: Procedure: Occipital nerve peripheral nerve stimulation (PNS)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult outpatients receiving care at participating pain medicine and neurology clinics for refractory headache disorders, including occipital neuralgia, chronic migraine, chronic tension-type headache, chronic cluster headache, and cervicogenic headache.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Occipital nerve peripheral nerve stimulation (PNS); Temporary 60-day occipital nerve peripheral nerve stimulation (PNS) as part of routine care for refractory headache disorders.	Procedure: Occipital nerve peripheral nerve stimulation (PNS); Temporary 60-day occipital nerve PNS as part of routine care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in headache impact	Change in headache impact will be measured using the HIT-6 measures the impact of headache on daily life. Score range: 36-78; Impact Categories: ≤49: Little to no impact, 50-55: Some impact, 56-59: Substantial impact, ≥60: Severe impact. A reduction in score would indicate an improvement in headache.	60 days
Change in health care resource utilization (HCRU)	Change in HCRU will be assesssed by the change in frequency of emergency department visits for headache-related diagnoses during the 12 months after treatment compared with the pre-treatment period.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in numeric rating scale	Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).	12 months
Change in neck disability index	Neck Disability Index (NDI), the Range: 0-50, Categories: 0-4: No disability, 5-14: Mild disability, 15-24: Moderate disability, 25-34: Severe disability and 35-50: Complete disability	12 months
Change in global impression of change	Patient Global Impression of Change (PGIC), Seven-point scale: Very much worse; Much worse; A little worse; No change; A little improved; Much improved; Very much improved	12 months
IMMPACT ≥30% pain reduction	IMMPACT ≥30% pain reduction, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).	12 months
IMMPACT Pain Relief ≥50%	≥50% pain relief at 60 days, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).	60 days
IMMPACT Pain Relief ≥80%	≥80% pain relief at 60 days, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).	60 days
IMMPACT Pain Relief ≥50%	≥50% pain relief at 12 months, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).	12 months
Medication utilization	Patient medication utilization will include: opioid exposure, MEDD, Anticonvulsants, topical analgesics, trigger point injections, acupuncture, Botox.	12 months
Healthcare Utilization	Patient healthcare utilization will include: Primary care visits, Emergency department visits and Inpatient admissions.	12 months

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: April 20, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Peripheral Nerve Stimulation; Occipital Nerves
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Headache
• Other Study ID Numbers: 2000042318

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No