RecruitingNot ApplicableNCT07276035

Brain-Stomach Circuits in Chronic Nausea

TMS Neuromodulation of Brain-to-Stomach Circuits in Chronic Nausea


Sponsor

David Levinthal

Enrollment

219 participants

Start Date

Jan 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to determine whether stimulation of the brain-stomach connection can influence stomach activity in healthy adults and in individuals suffering from chronic nausea. The main questions it aims to answer are: * What are the best brain sites to influence the stomach? * What are the effects of different stimulation patterns on stomach activity? * Does the stimulation affect the sensation of nausea in participants suffering from chronic nausea? Researchers will use a non-invasive method of brain stimulation called Transcranial Magnetic Stimulation (TMS) and will record stomach responses with skin electrodes on the abdomen. Participants will: * Visit the clinic at least once, and for up to 9 times more over the course of several months. * Receive TMS while sitting in a chair similar to a dentist's chair. * Drink water or consume a test meal during each study visit.


Eligibility

Min Age: 21 YearsMax Age: 60 Years

Inclusion Criteria1

  • Adults between ages 21-60 years old, with and without CNVS diagnosis per self-report.

Exclusion Criteria16

  • body mass index (BMI) \> 30
  • pregnancy or intention to become pregnant
  • past or present chemotherapy
  • diagnosis of gastric (stomach) cancer
  • any kind of gastric (stomach) surgery
  • current use of GLP-1 receptor agonists (e.g. Ozempic, Trulicity)
  • medications which significantly lower seizure thresholds (e.g. bupropion (Wellbutrin), fluoxetine (Prozac), or tramadol (Ultram))
  • implantable devices, such as a pacemakers or nerve stimulators
  • history of head injury that required hospitalization, metal in the skull, or neurologic disease such as stroke, history of seizures or history of syncope (fainting or passing out)
  • neurodegenerative disease (Multiple Sclerosis, Parkinson's or Alzheimer's Disease)
  • ongoing psychosis or altered cognitive status status (e.g. hearing sounds or seeing visions that are not there, or feeling confused or suffering from memory lapses)
  • history of cardiovascular (i.e., heart attack), pulmonary (i.e., need for supplemental oxygen), or endocrine disease (e.g. diabetes)
  • current enrollment in another study using Transcranial Magnetic Stimulation (TMS)
  • current use of drugs such as amphetamines, methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or drinking 3 or more alcoholic drinks per day
  • For healthy subjects only: chronic history of gastrointestinal symptoms (e.g., nausea, indigestion, bloating, abdominal pain)
  • For CNVS subjects only: diagnosis of gastric motility disorder (e.g. gastroparesis/slow stomach emptying) or history of bowel obstruction (i.e., chronic partial small bowel obstruction)

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETranscranial Magnetic Stimulation, TMS

The best location for evoking an electromyographic (EMG) response of the first dorsal interosseus (FDI) muscle in left and right hand to stimulation of the primary (M1) motor cortex and the minimum stimulation intensity required to evoke a certain EMG response amplitude (Motor Threshold, MT) are determined. This serves as a reference to determine the best location and stimulation parameters to evoke GMEPs from M1 and pre-motor cortical areas. After identification of the GMEP hot-spot, a stomach filling task (water load test or test meal) is administered and changes in the electrogastrogram (EGG) are monitored. In subsequent study visits, the stomach filling task is preceded by application of neuromodulatory repetitive TMS (rTMS), targeted to the GMEP hotspot.


Locations(1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07276035


Related Trials