Utilization of 60-Day Peripheral Nerve Stimulation of the Occipital Nerves for the Treatment of Headache
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Occipital nerve peripheral nerve stimulation (PNS).
- Who it may be relevant to
- Registry conditions: Headache. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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.
Interventions
- Procedure Occipital nerve peripheral nerve stimulation (PNS)
Temporary 60-day occipital nerve PNS as part of routine care.
Primary outcome measures
- Change in headache impact [Time frame: 60 days]
- Change in health care resource utilization (HCRU) [Time frame: 12 months]
Secondary outcome measures (9)
- Change in numeric rating scale [Time frame: 12 months]
- Change in neck disability index [Time frame: 12 months]
- Change in global impression of change [Time frame: 12 months]
- IMMPACT ≥30% pain reduction [Time frame: 12 months]
- IMMPACT Pain Relief ≥50% [Time frame: 60 days]
- IMMPACT Pain Relief ≥80% [Time frame: 60 days]
- IMMPACT Pain Relief ≥50% [Time frame: 12 months]
- Medication utilization [Time frame: 12 months]
- Healthcare Utilization [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Yale — New Haven
- Yale — Old Saybrook
Identifiers
NCT: NCT07553533 · 2000042318