What is the mechanism of action of this treatment?

Non-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS) and vagus nerve stimulation (VNS), modulate neural activity to influence autonomic functions, including gastrointestinal motility. TMS uses magnetic fields to induce electrical currents in specific brain regions, potentially altering neural circuits involved in autonomic regulation. VNS stimulates the vagus nerve, which plays a crucial role in parasympathetic control of the gut. These mechanisms are significant for healthy subjects as they offer potential therapeutic strategies for managing functional gastrointestinal disorders without the need for invasive procedures or pharmacological interventions, thereby minimizing side effects and improving patient compliance.

What side effects are associated with this type of intervention?

Non-invasive brain stimulation techniques, such as transcranial magnetic stimulation (TMS) and remote electrical neuromodulation, have been studied for their therapeutic effects. Common side effects reported include mild device-associated adverse events such as a warm sensation, numbness in the arm or hand, redness, itching, tingling, muscle spasm, arm pain, shoulder pain, and neck pain. Serious adverse events are rare. TMS should be used cautiously in patients with epilepsy due to the theoretical risk of triggering seizures.

What prior FDA approvals exist?

There are no specific FDA-approved treatments mentioned in the provided context for non-invasive brain stimulation aimed at autonomic regulation and gastrointestinal function in healthy subjects. However, related treatments such as gastric electrical stimulation have been studied for their effects on gastrointestinal motility and symptom improvement in conditions like gastroparesis. Additionally, neuromodulation techniques are being explored for their potential benefits in various autonomic and gastrointestinal disorders.

What other types of research exist?

Promising novel alternatives to non-invasive brain stimulation for influencing autonomic regulation and gastrointestinal function include transcutaneous trigeminal nerve stimulation (TTNS) and vagal nerve stimulation (VNS). TTNS has shown potential in managing conditions like ADHD, which may have implications for autonomic regulation. VNS, particularly through electrical stimulation systems, has been used for weight loss and may influence gastrointestinal function by modulating neural communication between the brain and stomach.

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Non-invasive Brain Stimulation

Brain Stimulation for Gastrointestinal Disorders

N/A

Waitlist Available

Led By David J Levinthal, MD/PhD

Research Sponsored by David Levinthal

Eligibility Criteria Checklist

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

Must have

Participants without gastrointestinal symptoms (Healthy Subjects)

Adults between age 21 and 60

Must not have

history of head injury, metal in the skull, stroke, or a history of seizures

current use of the following medications or use of substances which are known to lower the seizure threshold: amitriptyline (Elavil), nortriptyline (Pamelor), imipramine (Tofranil), doxepin (Sinequan), clozapine (Clozaril), chlorpromazine (Thorazine), amphetamines or methamphetamine, Ecstasy, Ketamine, Angel Dust/phencyclidine (PCP), cocaine, or 3 or more alcoholic drinks per day

Timeline

Screening 3 weeks

Treatment Varies

Follow Up egg will be monitored for 15 minutes before and up to 1 hour after consumption of the nutrient drink or the test meal

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a non-invasive brain stimulation technique called rTMS on healthy people and those with IBS or FD. The goal is to see if it can help regulate automatic body functions like digestion and heart rate by changing brain activity. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has been used to treat various neurological and psychiatric conditions, including major depression, migraine-associated headaches, and obsessive-compulsive disorder.

Who is the study for?

This trial is for adults aged 21-60 with gastrointestinal issues like functional dyspepsia or irritable bowel syndrome, as well as healthy individuals without these symptoms. It's not for pregnant people, those with a BMI over 35, metal implants, history of gastric surgery, heavy alcohol use, certain medication users, or those with heart problems.

What is being tested?

The study tests the effects of rTMS (repetitive Transcranial Magnetic Stimulation), a non-invasive brain stimulation technique on autonomic regulation and gastrointestinal function to develop new treatments for GI disorders.

What are the potential side effects?

While the description doesn't list specific side effects of rTMS in this context, common ones can include headache, scalp discomfort at the site of stimulation, lightheadedness or seizures in rare cases.

Eligibility Criteria

Inclusion Criteria

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

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I do not have any stomach or intestinal problems.

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I am between 21 and 60 years old.

Exclusion Criteria

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

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I have had a head injury, stroke, seizures, or metal in my skull.

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I am not currently using medications or substances known to lower seizure threshold.

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I have had surgery on my stomach.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ egg will be monitored for 15 minutes before and up to 1 hour after consumption of the nutrient drink or the test meal

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~egg will be monitored for 15 minutes before and up to 1 hour after consumption of the nutrient drink or the test meal

This trial's timeline: 3 weeks for screening, Varies for treatment, and egg will be monitored for 15 minutes before and up to 1 hour after consumption of the nutrient drink or the test meal for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Electrogastrogram (EGG)

Volume threshold to satiety

Secondary study objectives

Cardiac Impedance

Heart rate variability

MEP responses

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study subjectsExperimental Treatment1 Intervention

At the baseline session, measures of autonomic activity (electrogastrogram - EGG, electrocardiogram - ECG, cardiac impedance - CI) will be monitored from about 15 minutes before up to 1 hour after consumption of a test meal, water or a nutrient drink. In addition, motor-evoked potentials (MEPs) elicited with paired pulse transcranial magnetic stimulation (ppTMS) will be assessed before and after the meal or drink. In subsequent sessions, repetitive transcranial magnetic stimulation (rTMS) is applied before the meal or drink. Based on responses to symptom surveys (IBS-SSS and PAGI-SYM), study subjects will be characterized as healthy or as having functional dyspepsia and/or IBS.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

rTMS

2016

Completed Phase 3

~840

0 / 5Eligibility 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

Non-invasive brain stimulation (NIBS) techniques, such as transcranial magnetic stimulation (TMS) and vagus nerve stimulation (VNS), modulate neural activity to influence autonomic functions, including gastrointestinal motility. TMS uses magnetic fields to induce electrical currents in specific brain regions, potentially altering neural circuits involved in autonomic regulation. VNS stimulates the vagus nerve, which plays a crucial role in parasympathetic control of the gut. These mechanisms are significant for healthy subjects as they offer potential therapeutic strategies for managing functional gastrointestinal disorders without the need for invasive procedures or pharmacological interventions, thereby minimizing side effects and improving patient compliance.

[Effect of chronic electric stimulation on colonic motricity. An experimental model. Results].[Cyclic nucleotides and serotonin in the blood of patients with functional and inflammatory diseases of the large intestine].Bioelectric neuromodulation for gastrointestinal disorders: effectiveness and mechanisms.