Cerebral Cortical Influences on Autonomic Function

NCT03869372 | Active Not Recruiting FDA Device

• 2 other identifiers: STUDY190100275K08DK101756-05
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

This is an exploratory neurophysiological study that will determine the impact of non-invasive brain stimulation on autonomic regulation, with a focus on gastrointestinal function. These studies should provide a basis for future brain-based neurotherapeutic strategies in patients with functional GI disorders.

Conditions

Healthy Subjects; Functional Dyspepsia; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Electrogastrogram (EGG)

  The EGG will be analyzed in the frequency domain using fast Fourier Transformation (FFT). The power spectrum will be divided into frequency bands (normal gastric activity (\~3 cycles per minute), slower than normal (bradygastria) and faster than normal (tachygastria)). rTMS-induced shifts in the power distribution across these frequency bands after consumption of water or a nutrient drink or a test meal will be compared to water or nutrient drink or test meal without rTMS.

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

• Volume threshold to satiety

  rTMS-induced shift in the volume of water or nutrient drink a subject can consume within a 5 min period before reaching satiety

  volumes will be determined immediately after the 5 min drinking window and compared across study sessions

Secondary Outcomes (3)

• MEP responses

  before and up to 1 hour after rTMS

• Heart rate variability

  before and up to 1 hour after rTMS

• Cardiac Impedance

  before and up to 1 hour after rTMS

Study Arms (1)

Study subjects

EXPERIMENTAL

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.

Device: rTMS

Interventions

rTMS DEVICE

In subsequent sessions, the same measures of autonomic activity and MEPs will be monitored but different patterns of repetitive TMS (rTMS) will be applied to motor cortex or other areas before the test meal, water or nutrient drink is consumed.

Study subjects

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults between age 21 and 60
• Participants without gastrointestinal symptoms (Healthy Subjects)
• Participants with gastrointestinal symptoms compatible with functional dyspepsia (FD) and or irritable bowel syndrome (IBS)

You may not qualify if:

• history of myocardial infarction, supplemental oxygen requirement, or diabetes
• history of chronic gastrointestinal symptoms (for healthy subjects only)
• history of gastric surgery
• psychosis or altered cognitive status
• history of head injury, metal in the skull, stroke, or a history of seizures
• implantable devices, such as a pacemaker or nerve stimulator
• 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
• pregnancy
• Body-Mass-Index (BMI) \> 35

Sponsors & Collaborators

• David Levinthal: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• David J Levinthal, MD/PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Subjects will act as their own controls: The investigators will assess measures of autonomic function at baseline and in response to various modes of TMS exposure.

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: March 11, 2019
• Study Start: April 5, 2019
• Primary Completion (Estimated): October 3, 2026
• Study Completion (Estimated): October 3, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months after article publication and up to 5 years thereafter.
• Access Criteria: Proposals to access trial data should be directed to the Principal Investigator (Dr. David Levinthal) at levinthald@upmc.edu, and if the researcher has a sound basis for the proposal, then requestors will be asked to sign a data access agreement (link to be determined).

Locations

US (1)