Active Stimulation: The Galvani System will be implanted in eligible participants, and stimulation will be turned ON
Study summary
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.
Eligibility
Sex
ALL
Min age
22 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 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.
* Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators).
* Previous splenectomy
* Any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery.
* 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.
* Chronic use of morphine or oxicodone
Primary outcome measure(s)
Safety and tolerability of the Galvani system — 12 weeks Incidence and relatedness of Adverse Events (AEs), which include clinically significant findings from Laboratory Safety Assessments (clinical chemistry and hematology), vital signs (blood pressure, heart rate, respiratory rate, and body temperature), and 12-Lead ECG
Trial sites (2)
Facility
City
Region
Status
Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology
Amsterdam
Netherlands
Recruiting
Greater Glasgow Health Board
Glasgow
United Kingdom
Recruiting
More Galvani Bioelectronics trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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