Ensayos clínicos

Inclusion Criteria: 

• At least 18 years old.
• Diagnosed cervicogenic headache (CGH) or occipital neuralgia (ON) (e.g., in accordance with International Classification of Headache Disorders 3rd edition [ICHD-3] criteria).
• Average occipital head pain score in the last week ≥ 4 on a scale of 0-10 (Brief Pain Inventory - Short Form [BPI-SF], question #5) at baseline.
• Average occipital head pain interference score in the last week ≥ 4 on a scale of 0-10 (BPI-SF, question #9) at baseline.
• Able to understand and willing to take part in study and comply with all study requirements.

Exclusion Criteria:

• Change of prescribed medications affecting pain from 4 weeks prior to the Consent and Baseline Visit (Visit 1).
• 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 a headache condition other than CGH or ON, including (but not limited to) episodic or chronic migraine, tension-type 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).
• 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 active cardiac implant (e.g., pacemaker or defibrillator); deep brain stimulator; metallic implant near the stimulation site such as cerebrospinal fluid (CSF) shunt or aneurysm clip; any other implantable neuro-stimulator whose stimulus current pathway may overlap with the SPRINT system, such as a spinal cord stimulator in the cervical region; or cochlear implant.
• Severe traumatic brain injury (TBI), spinal cord injury, 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 or planning to become pregnant during the study treatment period (either urine dipstick or serum in females of reproductive potential to be assessed prior to lead placement procedure).

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/30/23. Questions regarding updates should be directed to the study team contact.