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

NCT07553533 | Not Yet Recruiting

• 1 other identifier: 2000042318
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Headache

Keywords

Peripheral Nerve Stimulation; Occipital Nerves

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Change in numeric rating scale

  12 months

• Change in neck disability index

  12 months

• Change in global impression of change

  12 months

• IMMPACT ≥30% pain reduction

  12 months

• IMMPACT Pain Relief ≥50%

  60 days

Study Arms (1)

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)

Interventions

Occipital nerve peripheral nerve stimulation (PNS) PROCEDURE

Temporary 60-day occipital nerve PNS as part of routine care.

Occipital nerve peripheral nerve stimulation (PNS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04