RecruitingNot ApplicableNCT04955899

Safety of Splenic Stimulation for RA

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


Sponsor

Galvani Bioelectronics

Enrollment

5 participants

Start Date

Oct 20, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 22 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety of using a small electrical device to stimulate the spleen (via a nerve called the vagus nerve) as a treatment for rheumatoid arthritis (RA) — a chronic autoimmune disease causing joint pain and inflammation. This approach is called bioelectronic medicine and aims to calm the immune system without drugs. **You may be eligible if...** - You are between 22 and 75 years old - You have been diagnosed with adult-onset rheumatoid arthritis for at least 6 months - Your RA is currently active (you are still having symptoms) - You have tried at least 2 biologic drugs or JAK inhibitors for RA that did not work well enough - You are female with no childbearing potential **You may NOT be eligible if...** - You have had a previous vagotomy (surgical cutting of the vagus nerve) - You have a pacemaker, ICD, or other implanted electrical device - You have had your spleen removed - You have active or latent tuberculosis - You have HIV or active hepatitis B or C - You have uncontrolled inflammatory diseases, active serious infections, or a history of cancer in the past 5 years - You use chronic opioid pain medications (morphine or oxycodone) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEActive Stimulation

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


Locations(2)

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

Amsterdam, Netherlands

Greater Glasgow Health Board

Glasgow, United Kingdom

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NCT04955899


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