Clinical Trials

Inclusion Criteria: 

• ≥ 21 years old.
• Diagnosed cervicogenic headache (CGH) or occipital neuralgia (ON) (in accordance with International Classification of Headache Disorders 3 rd edition [ICHD-3] criteria).
• Average occipital head pain score in the last week ≥4 on a scale of 0-10 (BPISF, question #5) at baseline.
• Average pain interference score in the last week ≥4 on a scale of 0-10 (BPISF, question #9) at baseline.
• Able to understand and willing to take part in study and comply with all study requirements.

Additional inclusion criteria (assessed prior to the PNS lead implant procedure): 

• Moderate-severe baseline pain: Average occipital head pain intensity score of ≥4 (determined by calculating the mean “average pain” scores collected consecutively in a 7-day baseline diary, using Question #5 on the BPI-SF; mean score must be ≥4). Individuals are required to complete all 7 days of the baseline diary consecutively to be eligible to participate in the study because an inability to complete the baseline diary suggests an inability or unwillingness to comply with all study requirements.

Exclusion Criteria:

• Change of prescribed medications affecting pain within the past 4 weeks as indicated from subject-reported medication history.
• Radiofrequency ablation in the affected area within the last six months.
• Botulinum toxin injection in the affected area within the last three months.
• Steroid injection in the affected area within the last six weeks.
• Other confounding therapies including previous destructive ganglionectomy, rhizotomy section or neurectomy procedure affecting C2/C3/occipital distribution
• Beck Depression Inventory (BDI-II) score of > 20.
• Head pain is attributed to cancerous lesion or a headache condition other than CGH or ON, including (but not limited to) episodic or chronic migraine, tensiontype headache, analgesic medication over-use or withdrawal headache, cluster headache, or vascular and non-vascular intracranial disorders.
• Pain is primarily in the distribution of the lesser occipital nerves.
• ID Migraine screener score of ≥ 2.
• Current daily opioid use ≥ 50 MME (morphine milligram equivalents).
• Diabetes mellitus Type 1 or Type 2.
• Compromised immune system based on medical history (i.e., human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS), immunosuppressive therapies such as chemo treatment, radiation, sepsis, active joint or overlying skin infection of the cervical or occipital regions), or other condition that in the opinion of the investigator places the subject at increased risk.
• Implanted electrical stimulation device or metallic implant such as spinal cord stimulator, active cardiac implant (e.g., pacemaker or defibrillator), cochlear implant, cerebrospinal fluid (CSF) shunt, aneurysm clip, or deep brain stimulator.
• Severe traumatic brain injury (TBI) or other central nervous system (CNS) conditions including epilepsy that could be aggravated by the PNS treatment or confound the analysis.
• Allergy to skin-contact materials (stickers, bandages, tape etc.).
• Previous cervical or cranial occipital surgery, such as decompression of the occipital nerve(s), or cervical spine surgery such as laminectomy or fusion at or above the C3 level.
• Participation in any drug or device trial in the past 30 days.
• Any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement or bandaging) as determined by the Investigator.
• Potential secondary gain conflicts of interest (e.g., pending claims or receiving disability).
• .Vulnerable populations (e.g., prisoners, individuals that report to investigators).
• Pregnant (either urine dipstick or serum in females of reproductive potential; to be assessed prior to lead placement procedure).

Eligibility last updated 7/14/22. Questions regarding updates should be directed to the study team contact.