An observational study in Headache, sponsored by Yale University. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Yale University · Observational
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.
762 studies on the registry are indexed under Headache; 134 are open to participants now.
This study's planned enrollment of 300 is above the median of 139 across 168 observational studies indexed under Headache.
Browse Headache studies →Yale University is the lead sponsor of 1,770 studies on the registry; 294 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 129 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 12 months
Change in numeric rating scale
Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).
Time frame: 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
Time frame: 12 months
Change in global impression of change
Patient Global Impression of Change (PGIC), Seven-point scale: 1. Very much worse 2. Much worse 3. A little worse 4. No change 5. A little improved 6. Much improved 7. Very much improved
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 months
Medication utilization
Patient medication utilization will include: opioid exposure, MEDD, Anticonvulsants, topical analgesics, trigger point injections, acupuncture, Botox.
Time frame: 12 months
Healthcare Utilization
Patient healthcare utilization will include: Primary care visits, Emergency department visits and Inpatient admissions.
Time frame: 12 months
Plan to share: No
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