Neuromodulation for Ulcerative Colitis

Recruiting at 2 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

Trial Summary

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.

Is neuromodulation generally safe for humans?

Neuromodulation, including spinal cord and sacral nerve stimulation, is generally considered safe and is FDA-approved for certain conditions like urinary and bowel issues. However, there are rare cases where it may affect conditions like ulcerative colitis, as seen in one instance where spinal cord stimulation was linked to a relapse. ^{1 2 3 4 5}

How does neuromodulation treatment for ulcerative colitis differ from other treatments?

Neuromodulation treatment for ulcerative colitis is unique because it uses electrical stimulation to target the nervous system, aiming to reduce inflammation through an 'inflammatory reflex'. This approach is different from traditional treatments that primarily rely on medications to suppress the immune system. ^{2 3 6 7 8}

What is the purpose of this trial?

The BOOM-IBD2 clinical trial is designed to evaluate the effectiveness of sacral neuromodulation for the treatment of IBD.

Eligibility Criteria

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 have been diagnosed with ulcerative colitis.

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

Timeline

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

Treatment Details

Interventions

• Neuromodulation

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

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Relapsing ulcerative colitis associated with spinal cord stimulation. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Anti-Inflammatory Effects of Two-Week Sacral Nerve Stimulation Therapy in Patients With Ulcerative Colitis. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Sacral neuromodulation for refractory ulcerative colitis: safety and efficacy in a prospective observational series of eight patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Some Non-FDA Approved Uses for Neuromodulation: A Review of the Evidence. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Impact of Bioelectronic Medicine on the Neural Regulation of Pelvic Visceral Function. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

P072 Non-invasive Vagal Nerve Stimulation to Treat Crohn Disease and Ulcerative Colitis in Children and Young Adults: A Proof-of-Concept Clinical Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Bioelectric neuromodulation for gastrointestinal disorders: effectiveness and mechanisms. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Potential of Electrical Neuromodulation for Inflammatory Bowel Disease. [2021]