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Behavioural Intervention

Splenic Stimulation for Rheumatoid Arthritis

N/A
Recruiting
Research Sponsored by Galvani Bioelectronics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving treatment with standard dose(s) of conventional synthetic DMARD(s)
Inadequate Response to at least 2 biologic DMARDs and/or JAK-inhibitors (JAKis) including at least one TNF inhibitor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during period 4 (period 4 is up to 5 years in duration beyond period 3)
Awards & highlights

Study Summary

This trial will evaluate the safety and effectiveness of a new implantable device to treat rheumatoid arthritis. The device is placed under the skin and sends electrical impulses to the nerves in the spleen.

Who is the study for?
This trial is for adults aged 22-75 with active rheumatoid arthritis (RA) who haven't responded well to at least two biologic DMARDs or JAK inhibitors, including a TNF inhibitor. They must have stopped previous RA treatments for a specific time before joining. People with implanted electrical devices, significant psychiatric issues, substance abuse problems, certain infections like COVID-19 or tuberculosis, HIV, hepatitis B/C, or those who've had vagotomy or splenectomy can't join.Check my eligibility
What is being tested?
The study tests the Galvani System's safety and effects on stimulating the splenic neurovascular bundle in RA patients. It includes an initial randomized control phase where some get real stimulation and others sham (fake) treatment; followed by open label and treat-to-target periods; ending with long-term follow-up to assess outcomes.See study design
What are the potential side effects?
While not explicitly stated here, potential side effects may include discomfort at the implant site, infection risk from surgery or device presence in the body. There could also be unintended impacts on nearby organs due to nerve stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on standard doses of synthetic drugs for my autoimmune disease.
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I have not improved after trying at least two types of advanced arthritis medication.
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I have had rheumatoid arthritis for at least six months.
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I have active rheumatoid arthritis.
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I am between 22 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during period 4 (period 4 is up to 5 years in duration beyond period 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during period 4 (period 4 is up to 5 years in duration beyond period 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Secondary outcome measures
Change in DAS28-CRP
Change in DAS28-CRP in participants who are given Drug treatment with baricitinib during Period 2
Change in DAS28-CRP in participants who remain on active stimulation during Period 2
+18 more

Trial Design

7Treatment groups
Experimental Treatment
Placebo Group
Group I: RA drug combined with active stimulation, Period 3Experimental Treatment3 Interventions
Participants on baricitinib during Period 2 will have active stimulation added for 24 weeks. Participants will also receive a stable dose of csDMARD therapy.
Group II: Open label active stimulation, Period 2Experimental Treatment2 Interventions
Open label active stimulation for 12 additional weeks in addition to stable dose of csDMARD therapy.
Group III: Open label RA Drug, Period 2Experimental Treatment2 Interventions
Open label drug treatment with baricitinib for 12 weeks in addition to stable dose of csDMARD therapy.
Group IV: Long-term Follow-up, Period 4Experimental Treatment2 Interventions
Standard of care treatments with or without stimulation
Group V: Active stimulation combined with RA drug, Period 3Experimental Treatment3 Interventions
Participants on active stimulation during Period 2 will have baricitinib added for 24 weeks. Participants will also receive a stable dose of csDMARD therapy.
Group VI: Active Stimulation; Period 1Experimental Treatment2 Interventions
Active stimulation for 12 weeks in addition to stable dose of csDMARD therapy.
Group VII: Sham Stimulation; Period 1Placebo Group2 Interventions
Sham stimulation for 12 weeks in addition to stable dose of csDMARD therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Baricitinib
FDA approved

Find a Location

Who is running the clinical trial?

Galvani BioelectronicsLead Sponsor
2 Previous Clinical Trials
19 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
5 Patients Enrolled for Rheumatoid Arthritis
NAMSAOTHER
45 Previous Clinical Trials
16,895 Total Patients Enrolled
1 Trials studying Rheumatoid Arthritis
5 Patients Enrolled for Rheumatoid Arthritis
Q2 SolutionsIndustry Sponsor
13 Previous Clinical Trials
1,130 Total Patients Enrolled

Media Library

Galvani System (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05003310 — N/A
Rheumatoid Arthritis Research Study Groups: Long-term Follow-up, Period 4, RA drug combined with active stimulation, Period 3, Open label active stimulation, Period 2, Active stimulation combined with RA drug, Period 3, Open label RA Drug, Period 2, Active Stimulation; Period 1, Sham Stimulation; Period 1
Rheumatoid Arthritis Clinical Trial 2023: Galvani System Highlights & Side Effects. Trial Name: NCT05003310 — N/A
Galvani System (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05003310 — N/A
Rheumatoid Arthritis Patient Testimony for trial: Trial Name: NCT05003310 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations have been chosen to oversee this trial?

"At present, this trial is enlisting patients from 4 clinical sites located in Dallas, Brooklyn, Austin and other cities. For convenience's sake it may be best to choose the clinic closest to you in order to minimize travel needs if enrollment is successful."

Answered by AI

What upper limit has been imposed on the amount of participants in this investigation?

"The trial necessitates the enrolment of 28 qualified participants. The sponsor, Galvani Bioelectronics, will be conducting the study at various clinics such as Metroplex Clinical Research Center in Dallas and NYU Langone in Brooklyn."

Answered by AI

Is this experiment actively looking for participants?

"Indeed, information on clinicaltrials.gov confirms that this research endeavour is presently looking for participants. It was first published on October 19th 2021 and the latest changes were made on October 25th 2021. 28 individuals need to be recruited from 4 distinct medical locations."

Answered by AI

What criteria must participants meet to join this experiment?

"This medical experiment is including 28 individuals afflicted by rheumatoid arthritis, aged between 22 and 75. To qualify for this trial applicants must: have a sufficient period of abstinence from using biologic DMARDs or JAKi medications; identify as male or female; and display active symptoms of RA."

Answered by AI

Does this clinical trial have an upper limit for potential participants to be over 40 years of age?

"Eligible applicants for this medical trial must be within the age bracket of 22 to 75. Alternatively, there are 60 clinical trials that accept minors and 356 studies open to seniors."

Answered by AI

What conditions may be remedied with Active Stimulation therapies?

"Active Stimulation is a commonly used therapy for hospitalized patients. It has also been proven to help those suffering from COVID-19, ECMO treatment, and rheumatoid arthritis."

Answered by AI

Are there any other research projects that have incorporated Active Stimulation?

"Currently, 31 clinical trials into Active Stimulation are underway with 15 of them in Phase 3. Most studies involving this technique take place at sites located in Pune, Maharashtra but there are 1416 medical facilities around the world that offer these procedures."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Texas
Alabama
Other
How old are they?
18 - 65
What site did they apply to?
Metroplex Clinical Research Center
Pinnacle Research Group, LLC
St. David's Healthcare
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Methotrexate caused severe side-effects incl hair loss, extreme fatigue, GI issues & other. I was slated to try HUMERA, but my TB test (Quant Gold) returned an ‘undetrm’d/false positive’. Confm’d TB neg. w/bubble test. (Twice).
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Splenic Stimulation for RA
2021. "Splenic Stimulation for RA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05003310.
All > Rheumatoid Arthritis > Ra
~18 spots leftby Jan 2029
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