Using electrical stimulation to relieve head pain
The MONARCH (Multicenter Occipital Neuralgia and Cervicogenic Headache) Case Series Study: Treatment of Head Pain with the SPRINT® Peripheral Nerve Stimulation (PNS) System
This study is testing if a small device that sends electrical signals to the neck can help people with cervicogenic headaches and occipital neuralgia feel less pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SPR Therapeutics, Inc. Industry-sponsored |
| Locations | 10 sites (Santa Rosa, California and 9 other locations) |
| Trial ID | NCT05491915 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the SPRINT® Peripheral Nerve Stimulation (PNS) System in alleviating pain associated with cervicogenic headaches and occipital neuralgia. Participants will receive small amounts of electrical stimulation delivered to the nerves at the top of the neck to determine if this approach can provide pain relief. The device is FDA-cleared for temporary use, allowing researchers to assess its impact on chronic or acute pain conditions. The study will involve multiple locations to gather diverse patient data.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with cervicogenic headache or occipital neuralgia.
Not a fit: Patients who have undergone prior cervical or cranial occipital surgery or have implanted electronic devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, non-invasive treatment option for patients suffering from chronic head pain.
How similar studies have performed: Previous studies using peripheral nerve stimulation for pain relief have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Diagnosed cervicogenic headache (CGH) or occipital neuralgia (ON) Key Exclusion Criteria: * Prior cervical or cranial occipital surgery * Implanted electronic device (dependent on implant's intended treatment, location, and electrical current pathway) * Pregnant
Where this trial is running
Santa Rosa, California and 9 other locations
- Pacific Research Institute — Santa Rosa, California, United States (Active_not_recruiting)
- MedVadis Research — Waltham, Massachusetts, United States (Active_not_recruiting)
- Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
- Center of Clinical Research — Winston-Salem, North Carolina, United States (Recruiting)
- Pain Specialists of America - South Austin - James Casey — Austin, Texas, United States (Recruiting)
- Pain Specialists of America - Cedar Park — Cedar Park, Texas, United States (Recruiting)
- Institute of Precision Pain Medicine — Corpus Christi, Texas, United States (Recruiting)
- Pain Specialists of America - Round Rock — Round Rock, Texas, United States (Recruiting)
- Pain Specialists of America - San Marcos — San Marcos, Texas, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.