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Enrolling by Invitation

NCT Number: NCT07553533

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Occipital nerve peripheral nerve stimulation (PNS)

Procedure

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

Primary outcomes

  1. Change in headache impact

    Time frame: 60 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.

  2. Change in health care resource utilization (HCRU)

    Time frame: 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.

Secondary outcomes

  1. Change in numeric rating scale

    Time frame: 12 months

    Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).

  2. Change in neck disability index

    Time frame: 12 months

    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

  3. Change in global impression of change

    Time frame: 12 months

    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

  4. IMMPACT ≥30% pain reduction

    Time frame: 12 months

    IMMPACT ≥30% pain reduction, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).

  5. IMMPACT Pain Relief ≥50%

    Time frame: 60 days

    ≥50% pain relief at 60 days, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).

  6. IMMPACT Pain Relief ≥80%

    Time frame: 60 days

    ≥80% pain relief at 60 days, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).

  7. IMMPACT Pain Relief ≥50%

    Time frame: 12 months

    ≥50% pain relief at 12 months, Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).

  8. Medication utilization

    Time frame: 12 months

    Patient medication utilization will include: opioid exposure, MEDD, Anticonvulsants, topical analgesics, trigger point injections, acupuncture, Botox.

  9. Healthcare Utilization

    Time frame: 12 months

    Patient healthcare utilization will include: Primary care visits, Emergency department visits and Inpatient admissions.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 28, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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