Electrical stimulation of the spleen for rheumatoid arthritis treatment
Multipart Exploratory Study to Evaluate Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis
This study is testing if using electrical stimulation on the spleen can help people with rheumatoid arthritis who haven't found relief from other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | Galvani Bioelectronics Industry-sponsored |
| Locations | 14 sites (Anniston, Alabama and 13 other locations) |
| Trial ID | NCT05003310 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effects of stimulating the splenic neurovascular bundle using the Galvani System in patients with active rheumatoid arthritis (RA) who have not responded adequately to at least two biologic DMARDs or JAK inhibitors. Participants will be randomly assigned to receive either active or sham stimulation for 12 weeks, followed by an open-label phase where non-responders will switch to a market-approved RA drug. Those who respond will enter a treat-to-target phase combining stimulation with medication for up to 24 weeks, followed by a long-term follow-up period of five years to assess safety. The study aims to gather data on the efficacy of this novel approach in managing RA symptoms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22-75 with active rheumatoid arthritis and inadequate response to at least two biologic DMARDs or JAK inhibitors.
Not a fit: Patients with significant psychiatric disorders, active infections, or those currently using electrically active medical devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new treatment option for patients with rheumatoid arthritis who have not responded to existing therapies.
How similar studies have performed: While the approach of splenic stimulation is novel, similar studies involving electrical stimulation for inflammatory conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * RA of at least six months duration, per 2010 ACR/EULAR criteria * Male or female participants, 22-75 years of age * Active RA * Inadequate Response to at least 2 biologic DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor * Have an appropriate washout from previously used biological DMARDs or JAKi * Receiving current treatment with standard dose(s) of conventional synthetic DMARD(s) or have documented history of failure due to ineffectiveness or intolerance Exclusion Criteria: * Inability to provide informed consent * Significant psychiatric disease or substance abuse * History of unilateral or bilateral vagotomy * Active or latent tuberculosis * Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B * Positive SARS COV 2 PCR screening test for COVID-19 infection (at the point of screening for this study) * Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators) * Previous splenectomy
Where this trial is running
Anniston, Alabama and 13 other locations
- Pinnacle Research Group, LLC — Anniston, Alabama, United States (Withdrawn)
- Medvin Research - Covina — Covina, California, United States (Recruiting)
- Medvin Research - Whittier — Whittier, California, United States (Recruiting)
- The Osteoporosis & Clinical Trials Center — Hagerstown, Maryland, United States (Recruiting)
- NYU Langone — Brooklyn, New York, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- Altoona Center for Clinical Research — Altoona, Pennsylvania, United States (Recruiting)
- Arthritis & Rheumatology Institute — Allen, Texas, United States (Recruiting)
- St. David's Healthcare — Austin, Texas, United States (Recruiting)
- Tekton Research — Austin, Texas, United States (Recruiting)
- Metroplex Clinical Research Center — Dallas, Texas, United States (Withdrawn)
- Southwest Rheumatology Research — Mesquite, Texas, United States (Recruiting)
- Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology — Amsterdam, Netherlands (Recruiting)
- Maxima Medical Center, MMC — Eindhoven, Netherlands (Recruiting)
Study contacts
- Study coordinator: Operations Director
- Email: clinical@galvani.bio
- Phone: +1 877 613 9001
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.