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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

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

Study Summary

This trial will use a brain stimulation technique to see if it can improve gastrointestinal function in patients with disorders.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Electrogastrogram (EGG)

Volume threshold to satiety

Secondary outcome measures

Cardiac Impedance

Heart rate variability

MEP responses

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

David LevinthalLead Sponsor

1 Previous Clinical Trials

11 Total Patients Enrolled

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

2,357 Previous Clinical Trials

4,314,942 Total Patients Enrolled

David J Levinthal, MD/PhDPrincipal InvestigatorUniversity of Pittsburgh

Media Library

rTMS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03869372 — N/A

Healthy Subjects Research Study Groups: Study subjects

Healthy Subjects Clinical Trial 2023: rTMS Highlights & Side Effects. Trial Name: NCT03869372 — N/A

rTMS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03869372 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research sampling include individuals over 45 years old?

"This trial's eligibility requirements specify that individuals between 21 and 60 can apply. There are 67 studies available for minors, while 463 exist to serve the elderly population."

Answered by AI

What criteria must potential participants meet to join this experiment?

"This clinical trial is recruiting 224 individuals, aged 21 to 60, who have been clinically diagnosed with irritable bowel syndrome. Other qualifying criteria include having symptoms characteristic of functional dyspepsia and/or IBS while being free from any other gastrointestinal issues."

Answered by AI

What is the scope of participation in this medical endeavor?

"Affirmative. Evidence from clinicaltrials.gov attests that this medical trial, first posted on April 5th 2019, is still enrolling patients. A total of 224 participants must be recruited at one site."

Answered by AI

Is there available space for participants in this clinical experiment?

"The current status of this medical trial, as depicted on clinicaltrials.gov, is open for recruitment. This study was first advertised in April 2019 and had its most recent update a few months ago at the end of March 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cerebral Cortical Influences on Autonomic Function

David Levinthal 2019. "Cerebral Cortical Influences on Autonomic Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03869372.

All > Irritable Bowel Syndrome > Dyspepsia