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Neuromodulation
Neuromodulation for Bowel Incontinence (TNT Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 48 weeks
Awards & highlights
TNT Trial Summary
This trial is investigating a non-invasive treatment for fecal incontinence that uses magnetic stimulation, to see if it is effective and how it works.
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.Check my eligibility
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.See study design
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.
TNT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least one episode of incontinence per week.
Select...
I have had recurring episodes of fecal incontinence for 6 months.
TNT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks, 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreTNT 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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalOTHER
2,932 Previous Clinical Trials
13,198,365 Total Patients Enrolled
Augusta UniversityLead Sponsor
211 Previous Clinical Trials
84,936 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,698 Previous Clinical Trials
7,492,367 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant.I have had at least one episode of incontinence per week.I have a condition where part of my rectum sticks out of my anus.I have been diagnosed with either ulcerative colitis or Crohn's disease.I do not have severe heart issues, chronic kidney failure, or major GI surgery history except for gallbladder or appendix removal.I have no active issues like anal fissures, abscesses, malformations, fistulae, or severe hemorrhoids.I experience severe diarrhea, with more than 6 liquid stools a day.I have had a radical hysterectomy or pelvic surgery/radiation.I have a neurological condition like epilepsy or MS, or have had a serious head injury.You are currently taking opioids for pain management.I am currently experiencing depression.I have had recurring episodes of fecal incontinence for 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Sham TNT Treatment
- Group 2: 1 Hz 2400 TNT Treatment
- Group 3: 1 Hz 3600 TNT Treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What objectives is this research endeavor attempting to fulfill?
"This 48 week clinical trial has a primary aim of measuring ano-cortical CEP response latency. Secondary endpoints include Bowel Urgency (defined as the inability to defer bowel movement for more than 15 minutes), and Psychological Function PROMIS Questionnaires assessing anxiety symptoms and self-efficacy in managing symptoms, both on scales between 1 (never/not at all confident) and 5 (always/very confident)."
Answered by AI
What is the recruitment quota for this research effort?
"Correct. The details on clinicaltrials.gov suggest that this trial is currently enrolling patients. Initially posted on June 5th 2019, the trial requires 132 participants across 2 sites to be recruited by July 19th 2022."
Answered by AI
Are there opportunities for participants to join this experiment?
"According to clinicaltrials.gov, this research endeavor is actively receiving applications. It was first made public on June 5th 2019 and has been revised as of July 19th 2022."
Answered by AI
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