At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Active Stimulation (device)
- How long the study runs
- Study runs about 90 months (dates as stated)
- About the drug or intervention
- Active Stimulation — device: The Galvani System will be implanted in eligible participants, and stimulation will be turned ON
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Galvani Bioelectronics, is looking at the safety of splenic (spleen) stimulation in people with rheumatoid arthritis (RA), a condition where the immune system attacks the joints. It is for adults whose RA is still active despite trying at least two biologic medicines or JAK inhibitors (a type of medicine for RA).
Who can take part
- Adults aged 22 to 75 with adult-onset rheumatoid arthritis lasting at least six months
- Active rheumatoid arthritis
- RA that has not responded well to at least 2 biologic DMARDs (disease-modifying medicines) and/or JAK inhibitors
- A suitable break (washout) from previous biologic DMARDs or JAK inhibitors
- Female participants must have no ability to become pregnant
Who may not be able to
- Unable to give informed consent
- Significant mental illness or substance abuse
- History of vagotomy (surgery cutting the vagus nerve)
- Active or hidden tuberculosis (TB)
- HIV infection; current acute or chronic hepatitis B or C; or past hepatitis B
- Currently having an implanted electrical device, such as a pacemaker or defibrillator
- Previous surgery to remove the spleen (splenectomy)
- Taking an experimental drug within 2 weeks or 2 half-lives (whichever is longer) before surgery
- Other uncontrolled inflammatory diseases
- Current or repeated infections that the lead researcher feels make the risks outweigh the benefits
- Cancer in the past 5 years, except non-malignant skin cancer
- Long-term use of morphine or oxycodone (strong painkillers)
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about how many visits there are, how long the trial lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 22 Years to 75 Years
- Who
- All
- Number of participants
- 5
- Started
- 2021-10-20
- Last checked
- 2024-02
Plain English Summary
What is this study?
- • Testing a new treatment for rheumatoid arthritis
- • NA - 5 participants
- • 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
Who can take part?
- • Ages 22 Years to 75 Years
- • Diagnosed with rheumatoid arthritis
Where?
- • Glasgow - Greater Glasgow Health Board
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 22 Years - 75 Years
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗Inability to provide agreement to take part.
- ✗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;...
See the full criteria
Where Is This Study? (1 UK site)
Greater Glasgow Health Board
Glasgow G12 OXH, United Kingdom
How to Get in Touch
Operations Director
Sponsor contactCONTACT