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NCT Number: NCT04955899

Safety of Splenic Stimulation for RA

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Inflammation Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology, Amsterdam, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active stimulation

Device

The Galvani System will be implanted in eligible participants, and stimulation will be turned ON

Primary outcomes

  1. Safety and tolerability of the Galvani system

    Time frame: 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

Secondary outcomes

  1. Effect of stimulation on the change in pharmacodynamic and response biomarkers

    Time frame: Day 1 to week 12

    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

  2. To evaluate the usability of the external Galvani System devices and accessories

    Time frame: 12 weeks

    Summarize feedback collected on questionnaires pertaining to the use of the external Galvani System devices

  3. To evaluate the participants' perception of therapy and sensation

    Time frame: 12 weeks

    Summarize feedback collected on questionnaires

  4. Evaluate device performance

    Time frame: 12 weeks

    Tabulation of device deficiencies

Study contacts

Contact information is provided by the study sponsor or research team.

Operations Director

CONTACT

[email protected]

+44 (0)800 3688514

Sponsors and collaborators

Lead sponsor

Galvani Bioelectronics

Industry

Collaborators

  • NAMSA

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Jul 9, 2021
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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