Testing a Device That Stimulates the Spleen Nerve in Rheumatoid Arthritis
Tests a small implanted device stimulating a spleen nerve in adults with rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: Safety of Splenic Stimulation for RA
Key facts
- Where
- Amsterdam, NetherlandsSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 75 years old?
Source: NCT04955899, who can take part
Where in Netherlands
- Academic Medical Center (AMC) Dept of Rheumatology & Clinical ImmunologyAmsterdam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Galvani Bioelectronics
- Trial code
- NCT04955899
- Record updated
- 14 February 2024
- Original description
This study will evaluate the safety and tolerability of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. Participants eligible for implant will have active rheumatoid arthritis (RA) and have an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors (JAKis). Five participants will be implanted with the device and receive neurostimulation for 12 weeks.Read full original descriptionShow less
A Single Arm Pilot Study to Evaluate the Safety and Feasibility of Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis Using an Active Implantable Device
This study will evaluate the safety and tolerability of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. Participants eligible for implant will have active rheumatoid arthritis (RA) and have an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors (JAKis). Five participants will be implanted with the device and receive neurostimulation for 12 weeks.
Inclusion: Adult-onset RA of at least six months duration; Male or female participants, 22-75 years of age; Active RA; Inadequate Response to at least 2 biologic DMARDs and/or JAK- inhibitors (JAKis); Have an appropriate washout from previously used biological DMARDs or JAKi; A female participant should have no child-bearing potential.
Exclusion: Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B; Previous splenectomy; Any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery; Significant psychiatric disease or substance abuse; History of unilateral or bilateral vagotomy; Active or latent tuberculosis; Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators); Uncontrolled other inflammatory diseases; Current/recurrent infections that in the opinion of the PI risk>benefit; History of cancer within the past 5 years, except non-malignant skin cancer; Inability to provide informed consent; Chronic use of morphine or oxicodone.