Neuromodulation for Ulcerative Colitis

Recruiting at 11 trial locations

Overseen By Malea D'Amico

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boomerang Medical

Disqualifiers: Cancer, Psychiatric disorder, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

137 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether sacral neuromodulation, a type of neuromodulation therapy, can help individuals with ulcerative colitis, a condition causing inflammation in the colon and symptoms like stomach pain and diarrhea. The treatment stimulates nerves to determine if it can alleviate these symptoms. Individuals diagnosed with ulcerative colitis who find it impacts their daily life might be suitable candidates for this trial. As an unphased trial, it offers patients the chance to explore innovative treatment options that could potentially enhance their quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that neuromodulation is safe for treating ulcerative colitis?

Research has shown that sacral neuromodulation, a type of electrical nerve stimulation, may help treat inflammatory bowel diseases like ulcerative colitis. After two weeks of treatment, 73% of patients responded positively, suggesting its effectiveness.

Regarding safety, studies indicate that neuromodulation is generally well-tolerated. Although long-term safety data is limited, early reports have not shown any major safety issues. Minor side effects might occur, but significant problems appear rare.

It is important to note that this treatment is still under study and not yet approved specifically for ulcerative colitis. However, its use in other conditions supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Neuromodulation is unique because it offers a new approach for treating ulcerative colitis by targeting the nervous system rather than the immune system or inflammation directly, which is how most current treatments like aminosalicylates, corticosteroids, and biologics work. This technique involves using electrical impulses to modulate nerve activity, potentially reducing inflammation in a novel way. Researchers are excited about this treatment because it could provide an option with fewer side effects and might be beneficial for patients who don't respond well to existing medications.

What evidence suggests that neuromodulation is effective for ulcerative colitis?

Research shows that using electrical signals to stimulate nerves, known as electrical neuromodulation, offers a promising new treatment for inflammatory bowel disease (IBD), including ulcerative colitis. This trial will evaluate the effects of neuromodulation on patients with ulcerative colitis. Some studies have examined different types of neuromodulation, such as vagus nerve stimulation, and found potential benefits for IBD patients. Although direct data on using sacral neuromodulation specifically for ulcerative colitis is limited, early results suggest it might work by affecting nerve pathways related to gut inflammation. Overall, this approach remains under study, but it appears promising based on its mechanism and initial findings. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women aged 18 to 85 who have been diagnosed with ulcerative colitis. Participants must be able to consent, follow the study's procedures, and attend all follow-ups. They should still have their entire colon intact.

Inclusion Criteria

I am either male or female.

I can follow the study's requirements and will attend all follow-ups.

I have been diagnosed with ulcerative colitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are implanted with sacral neuromodulation devices for the treatment of IBD

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neuromodulation

Trial Overview The BOOM-IBD2 trial is testing sacral neuromodulation, a technique that uses electrical stimulation to manage symptoms of ulcerative colitis.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

Patients implanted with neuromodulation

Neuromodulation is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Neuromodulation Therapy for:

• Chronic Neuropathic Pain
• Epilepsy
• Parkinson's Disease
• Urinary Incontinence

Approved in United States as Neuromodulation Therapy for:

• Chronic Neuropathic Pain
• Failed Back Surgery Syndrome
• Complex Regional Pain Syndrome
• Epilepsy
• Parkinson's Disease

Approved in Canada as Neuromodulation Therapy for:

• Chronic Neuropathic Pain
• Epilepsy
• Parkinson's Disease

Approved in Japan as Neuromodulation Therapy for:

• Chronic Neuropathic Pain
• Parkinson's Disease

Who Is Running the Clinical Trial?

Boomerang Medical

Lead Sponsor

Trials

2

Recruited

180+

Published Research Related to This Trial

Neuromodulation techniques, such as spinal cord stimulation and peripheral nerve field stimulation, show promising efficacy in treating painful conditions like coronary artery disease, peripheral vascular disease, and headaches, despite not being FDA approved for these uses.

The review analyzed a total of 24 studies, including 10 controlled studies for coronary artery disease, 6 for peripheral vascular disease, and 3 for headaches, providing compelling evidence that neuromodulation could benefit patients suffering from these serious conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Some Non-FDA Approved Uses for Neuromodulation: A Review of the Evidence. Lee, S., Abd-Elsayed, A.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9516456/

Electrical neuromodulation therapy for inflammatory bowel ... Electrical neuromodulation therapy has been studied as a possible treatment regimen for IBD. There are several forms of neuromodulation that use various types ...

2. crohnscolitisfoundation.org crohnscolitisfoundation.org/boom-ibd2-clinical-trial-to-evaluate-the-effectiveness-of-neuromodulation-ulcerative-colitis

BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of ... The objective of the BOOM-IBD2 clinical trial is to evaluate the effectiveness of an investigational nerve stimulation (neuromodulation) device for ulcerative ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925010360

Effectiveness of Noninvasive Phrenic Nerve ... A randomized controlled trial, with blinded assessors, was conducted with two intervention groups. A total of 68 subjects, aged >18 years, ...

4. academic.oup.com academic.oup.com/ibdjournal/article/26/8/1119/5648005

Potential of Electrical Neuromodulation for Inflammatory ... Electrical neuromodulation, also called bioelectronic medicine, is emerging as a potential new treatment for IBD.

5. mdpi.com mdpi.com/1648-9144/60/5/729

Exploring Electrical Neuromodulation as an Alternative ... Background and Objectives: This review systematically evaluates the potential of electrical neuromodulation techniques—vagus nerve stimulation (VNS), ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11123282/

Electrical Neuromodulation for Inflammatory Bowel Diseases This review systematically evaluates the potential of electrical neuromodulation techniques—vagus nerve stimulation (VNS), sacral nerve stimulation (SNS), and ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/P210037B.pdf

summary of safety and effectiveness data (ssed) The Prospera Spinal Cord Stimulation (SCS) system is indicated as an aid in the management of chronic, intractable pain in the trunk and/or ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S109471592300106X

Anti-Inflammatory Effects of Two-Week Sacral Nerve ... After two weeks, 73% of the subjects in the SNS group achieved clinical response, compared with 27% in the sham-SNS group.