Brain Stimulation for Gastrointestinal Disorders

Recruiting in Palo Alto (17 mi)

Overseen byDavid J Levinthal, MD/PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: David Levinthal

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I do not have any stomach or intestinal problems.

I am between 21 and 60 years old.

I have symptoms like those of irritable bowel syndrome or functional dyspepsia.

Exclusion Criteria

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

I have had a heart attack, need extra oxygen, or have diabetes.

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

+6 more

Participant Groups

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.

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 single pulse transcranial magnetic stimulation 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.

rTMS is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as rTMS for: