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Observational Study of Occipital Nerve Stimulation for Headache

This study is looking at how well temporary 60-day occipital nerve peripheral nerve stimulation (PNS) works for people with different types of severe headaches, like chronic migraine or occipital neuralgia. You could join if your doctor has already decided this treatment is right for you as part of your regular care. Researchers want to see if this treatment helps reduce your headache impact and how often you need to use healthcare resources over 12 months. This is an observational study, meaning researchers will collect information about your experience with the treatment you're already getting. The study aims to enroll 300 participants, but its current status is unclear.

Study design
This is an observational study involving 300 participants. Researchers will collect information about your experience with a treatment your doctor has already decided is right for you.
What's involved
You would be undergoing temporary 60-day occipital nerve PNS as part of your routine care. Researchers will then assess your headache impact and healthcare use over 12 months.
Compensation
Not stated in the trial record.
Follow-up
Your headache impact will be measured at 60 days, and your healthcare resource use will be measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07553533

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

Enrolling by Invitation
Not specifiedAges 18+Observational
Yale University
~300 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Occipital nerve peripheral nerve stimulation (PNS)

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in headache impact
Measured over 60 days
+1 more outcome measured

Conditions

Headache

Explore related trials

Cervicogenic headacheCervico-occipital neuralgiaChronic MigraineChronic tension-type headacheCluster Headache

Where it's being run

2 sites across 1 states
Connecticut2

Study leadership

  • Charles A Odonkor, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in headache impact60 days

    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.

  • Change in health care resource utilization (HCRU)12 months

    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.