HeadacheNCT07553533
Utilization of 60-Day Peripheral Nerve Stimulation of the Occipital Nerves for the Treatment of Headache
An observational study of Headache, run by Yale University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache
- What is being tested?
- Occipital nerve peripheral nerve stimulation (PNS)
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2026to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Inability to provide informed consent.
- Coagulopathy that would prohibit PNS placement.
- Severe psychiatric illness interfering with participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Yale
New Haven, Connecticut, 06520
Yale
Old Saybrook, Connecticut, 06475
About this study
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
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.
Read the 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.
- Conditions
- Headache
- Being tested
- Occipital nerve peripheral nerve stimulation (PNS)
- Keywords
- Peripheral Nerve Stimulation, Occipital Nerves
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occipital nerve peripheral nerve stimulation (PNS)Procedure or surgery
Temporary 60-day occipital nerve PNS as part of routine care.
| Study group | Role | What they receive |
|---|---|---|
| Occipital nerve peripheral nerve stimulation (PNS) | Temporary 60-day occipital nerve peripheral nerve stimulation (PNS) as part of routine care for refractory headache disorders. Receives: Procedure: Occipital nerve peripheral nerve stimulation (PNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (9)
Change in numeric rating scale
Numeric Rating Scale (NRS) is a single item, typically 0-10 (0 = no pain, 10 = worst imaginable pain).
Measured: 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
Measured: 12 months
Change in global impression of change
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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months
Medication utilization
Patient medication utilization will include: opioid exposure, MEDD, Anticonvulsants, topical analgesics, trigger point injections, acupuncture, Botox.
Measured: 12 months
Healthcare Utilization
Patient healthcare utilization will include: Primary care visits, Emergency department visits and Inpatient admissions.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 May 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles A Odonkor, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553533
- Sponsor's protocol ID
- 2000042318
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07553533
- Acronym / sponsor ID
- 2000042318
- Conditions
- Headache
- Keywords
- Peripheral Nerve Stimulation, Occipital Nerves
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occipital nerve peripheral nerve stimulation (PNS) | – | Procedure: Occipital nerve peripheral nerve stimulation (PNS)Temporary 60-day occipital nerve peripheral nerve stimulation (PNS) as part of routine care for refractory headache disorders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to provide informed consent.
- Coagulopathy that would prohibit PNS placement.
- Severe psychiatric illness interfering with participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occipital nerve peripheral nerve stimulation (PNS)Temporary 60-day occipital nerve PNS as part of routine care. | Procedure or surgery | Occipital nerve peripheral nerve stimulation (PNS) |
Primary outcome
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.
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Headache
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles A Odonkor, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in headache impact (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.