Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03869372

Cerebral Cortical Influences on Autonomic Function

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

About this study

The overall goal of this study is to determine the impact of non-invasive brain stimulation on autonomic function in human subjects without functional gastrointestinal disorders and in subjects with Irritable Bowel Syndrome (IBS) or Functional Dyspepsia (FD).

Aim 1: Determine whether repetitive transcranial magnetic stimulation (rTMS) of specific cortical areas alters physiologic measures of gastrointestinal and cardiac function.

The investigators will use rTMS to transiently induce changes in neural excitability within specific cortical regions identified as being linked to autonomic regulation. Based on preliminary neuroanatomical data, one of the leading candidate cortical areas associated with sympathetic regulation lies within the trunk representation of the primary motor cortex. Thus, the investigators first plan on targeting this region of the primary motor cortex with rTMS and assess the effect of various parameters of rTMS on gastrointestinal and cardiac function in healthy human subjects. The investigators will then perform additional experiments using rTMS targeted to other specific cortical sites, such as the dorsal premotor area and rostral cingulate cortex that have also been linked to autonomic control. Each of these identified cortical regions may make unique contributions to autonomic reactivity.

Aim 2: Determine whether patients with functional gastrointestinal disorders demonstrate altered physiological reactivity to targeted rTMS.

The investigators will use the optimal parameters of rTMS and regions of interest determined in Aim 1 to assess the gastrointestinal and cardiac reactivity in participants with functional dyspepsia (FD) and/or irritable bowel syndrome (IBS). These physiological responses will be correlated with assessments of disease severity, mood, and quality of life.

--This study description has been revised since its original posting. Because all study procedures are performed in all subjects, regardless of being a healthy subject or one with FD and/or IBS, rather than a three arm trial, this trial should be regarded as having a single arm study design.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Electrogastrogram (EGG)

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

    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.

  2. Volume threshold to satiety

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

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

Secondary outcomes

  1. MEP responses

    Time frame: before and up to 1 hour after rTMS

    rTMS-induced change in the amplitude of motor evoked potentials (MEP) elicited by single pulse TMS

  2. Heart rate variability

    Time frame: before and up to 1 hour after rTMS

    rTMS-induced change in heart rate variability elicited by Valsalva maneuver or diaphragmatic breathing

  3. Cardiac Impedance

    Time frame: before and up to 1 hour after rTMS

    rTMS-induced change in cardiac impedance variability

Sponsors and collaborators

Lead sponsor

David Levinthal

Other

Collaborators

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

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2019
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.