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.
The study will be an open-label single-arm study to evaluate the safety and tolerability of Galvani's neuromodulation system. Participants with active rheumatoid arthritis (RA) will be implanted with the Galvani system and receive active stimulation for 12 weeks. The total study duration in the study for each participant is approximately 5 months, with a 4-week screening period, 4 weeks recovery from surgery and a 12-week 'treatment' period. The participants will return to the clinic on pre-defined days for follow-up visits during the trial period. At Days 42 and/or Day 56, if study participants are not responding to stimulation, stimulation parameters might be adapted. At the end of the study (Day-84), participants will enroll in a long-term follow-up study up to 5-years after enrollment in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
5
The Galvani System will be implanted in eligible participants, and stimulation will be turned ON
Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology
Amsterdam, Netherlands
RECRUITINGGreater Glasgow Health Board
Glasgow, United Kingdom
RECRUITINGSafety and tolerability of the Galvani system
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
Time frame: 12 weeks
Effect of stimulation on the change in pharmacodynamic and response biomarkers
Changes from baseline (Day 1) in the levels of LPS-inducible cytokine/ chemokine release, in whole blood assay at different timepoints after start of stimulation
Time frame: Day 1 to week 12
To evaluate the usability of the external Galvani System devices and accessories
Summarize feedback collected on questionnaires pertaining to the use of the external Galvani System devices
Time frame: 12 weeks
To evaluate the participants' perception of therapy and sensation
Summarize feedback collected on questionnaires
Time frame: 12 weeks
Evaluate device performance
Tabulation of device deficiencies
Time frame: 12 weeks
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