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Safety of Splenic Stimulation for RA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04955899
Recruitment Status : Recruiting
First Posted : July 9, 2021
Last Update Posted : October 26, 2021
Sponsor:
Collaborator:
NAMSA
Information provided by (Responsible Party):
Galvani Bioelectronics

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: Active Stimulation Not Applicable

Detailed Description:
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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official 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
Actual Study Start Date : October 20, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Stimulation
Active stimulation for 12 weeks
 Device: Active Stimulation
The Galvani System will be implanted in eligible participants, and stimulation will be turned ON


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04955899


Contacts
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Contact: Operations Director +44 (0)800 3688514 clinical@galvani.bio

Locations
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United Kingdom
Greater Glasgow Health Board Recruiting
Glasgow, United Kingdom, G12 OXH
Contact: Operations Director    +44 (0)800 3688514    clinical@galvani.bio   
Sponsors and Collaborators
Galvani Bioelectronics
NAMSA
More Information
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Responsible Party: Galvani Bioelectronics
ClinicalTrials.gov Identifier: NCT04955899    
Other Study ID Numbers: GAL1039
First Posted: July 9, 2021    Key Record Dates
Last Update Posted: October 26, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Galvani Bioelectronics:
Electrical stimulation
inflammation
active implantable medical device
Laparoscopy
 antirheumatic agents
autonomic nervous system
feasibility studies
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases