What side effects are associated with this type of intervention?

Neuromodulation therapies for bowel incontinence, such as Translumbosacral Neuromodulation Therapy (TNT), generally have mild side effects. These can include local discomfort at the site of stimulation, tingling sensations, and temporary muscle spasms. More serious adverse events are rare but can include infection, hardware malfunctions, and, in very rare cases, neurological complications. Overall, these treatments are considered safe and well-tolerated, with most side effects being reversible upon adjustment or cessation of therapy.

What other types of research exist?

Promising, novel alternatives to Translumbosacral Neuromodulation Therapy for bowel incontinence patients include: 1) Vagus Nerve Stimulation (VNS), which has shown efficacy in treatment-resistant depression and may enhance neural excitability and neuroplasticity; 2) Transcranial Magnetic Stimulation (TMS), particularly deep TMS, which has been effective in reducing depressive relapses and may have potential for bowel incontinence; 3) Spinal Cord Stimulation (SCS), which has been used for chronic pain and may improve neural control of bowel function.

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Neuromodulation

Neuromodulation for Bowel Incontinence (TNT Trial)

Q: What prior FDA approvals exist?

The FDA has approved several neuromodulation therapies for the treatment of bowel incontinence. One notable example is sacral nerve stimulation (SNS), which modulates neural pathways to improve bowel control. This therapy involves the implantation of a device that stimulates the sacral nerves, enhancing neural excitability and inducing neuroplasticity, similar to the mechanisms proposed for Translumbosacral Neuromodulation Therapy (TNT). Other treatments, such as percutaneous tibial nerve stimulation (PTNS), have also been explored for their efficacy in treating bowel incontinence by targeting neural pathways to improve sensory and motor control.

N/A

Recruiting

Research Sponsored by Augusta University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On a 2-week stool diary patients reported at least one episode of solid or liquid FI/week

Recurrent episodes of FI for 6 months

Must not have

rectal prolapse

Ulcerative and Crohn's colitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks, 48 weeks

Summary

This trial is testing a new treatment called Translumbosacral Neuromodulation Therapy (TNT) for people with fecal incontinence (FI), especially women and elderly individuals. TNT uses magnetic pulses to stimulate nerves in the lower back, helping to improve control over bowel movements. The goal is to provide a more effective, non-invasive treatment option for those who struggle with FI.

Who is the study for?

This trial is for adults who've had bowel incontinence for at least 6 months, with weekly episodes. They must not have mucosal diseases, be on opioids, or have a range of other conditions like Crohn's disease, severe heart issues, metal implants near the treatment area, pacemakers, or certain past surgeries.

What is being tested?

The study tests Translumbosacral Neuromodulation Therapy (TNT) against a sham (fake) therapy to see if TNT can improve bowel control by stimulating nerves with magnetic fields. It aims to find the best dose and understand how it works over short and long terms.

What are the potential side effects?

While specific side effects are not listed here, non-invasive magnetic stimulation therapies like TNT may cause discomfort at the site of application or mild headaches. Serious side effects are rare but could include seizures in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had at least one episode of incontinence per week.

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I have had recurring episodes of fecal incontinence for 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition where part of my rectum sticks out of my anus.

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I have been diagnosed with either ulcerative colitis or Crohn's disease.

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I do not have severe heart issues, chronic kidney failure, or major GI surgery history except for gallbladder or appendix removal.

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I have no active issues like anal fissures, abscesses, malformations, fistulae, or severe hemorrhoids.

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I experience severe diarrhea, with more than 6 liquid stools a day.

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I have had a radical hysterectomy or pelvic surgery/radiation.

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I have a neurological condition like epilepsy or MS, or have had a serious head injury.

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I am currently experiencing depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks,4 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks,4 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks,4 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AIM 1 measure is the proportion of patients achieving >50% of reduction in fecal incontinence episodes/weeks at the end of 6 weeks compared to baseline.

AIM 2: Latencies for lumbo-anal Magnetic Evoked Potentials (MEP) responses compared to baseline

AIM 2: Latencies for sacro-anal MEP responses compared to baseline

+5 more

Secondary study objectives

Amplitudes (Milivolts of the nerve) for lumbo-rectal MEP compared to baseline

Amplitudes (Milivolts of the nerve) for recto-cortical CEP responses

Amplitudes (Milivolts of the nerve) for sacro-rectal MEP

+24 more

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: 1 Hz 2400 TNT TreatmentActive Control1 Intervention

Intervention: TNT treatment intervention with 2400 total stimulations with the magnetic coil..

Group II: 1 Hz 3600 TNT TreatmentActive Control1 Intervention

Intervention: TNT treatment intervention with 3600 total stimulations with the magnetic coil.

Group III: Sham TNT TreatmentPlacebo Group1 Intervention

This arm will have the sham treatment session. First we will assess the motor threshold intensity described above. Next, a sham coil is placed on each of 4 regions (2 lumbar \& 2 sacral), and 600 stimulations will be given at each site in 2 trains, with a 5 minutes rest period between each site and 3 minutes between trains.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Bowel Incontinence, such as Translumbosacral Neuromodulation Therapy (TNT), work by enhancing neural excitability and inducing neuroplasticity. These mechanisms improve sensory and motor control by modulating neuronal perturbations, which in turn enhance bidirectional gut-brain signaling, anal sphincter strength, and rectal sensation. This is important for Bowel Incontinence patients as it offers a durable, non-invasive, and low-risk treatment option that addresses the underlying neurobiologic dysfunctions contributing to their condition.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER

3,026 Previous Clinical Trials

13,413,688 Total Patients Enrolled

Augusta UniversityLead Sponsor

215 Previous Clinical Trials

85,558 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,840 Previous Clinical Trials

8,171,991 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,464 Previous Clinical Trials

4,337,321 Total Patients Enrolled

Satish Rao, MD,PhD4.130 ReviewsStudy Director - Augusta University

Augusta University

5Patient Review

Dr. Rao was everything I could hope for and more. Despite the significant distance I had to travel, it was well worth it. I had been struggling with SIBO for years and he was able to provide a much-needed diagnosis. The only drawback is the lack of communication and follow-up after the initial visit. Otherwise, the staff are amazing and I would recommend him to anyone seeking answers to their motility issues.