Recruiting

TMS

Sponsor:

David Levinthal

Code:

NCT07276035

Conditions

Chronic Nausea and Vomiting Syndrome

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

Interventions

Transcranial Magnetic Stimulation, TMS

Study Details

Brief 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.

Conditions

Chronic Nausea and Vomiting Syndrome

Study ID

NCT07276035

Start date

Jan 28, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2031

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

219 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Healthy subjects and CNVS subjects

Subjects without gastric problems and subjects with Chronic Nausea and Vomiting (CNVS)

Interventions

Transcranial 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.

Primary outcome measure

  • GMEP location [ Time Frame: Baseline session ]
  • EGG power change [ Time Frame: Each study session through study completion, up to 1 year ]

Central Contacts and Locations

Central contacts

Elijah D Wright

412-647-1228edw87@pitt.edu

David J Levinthal, MD PhD

412-303-0525levinthald@upmc.edu

Locations

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

More Information

Sponsor

David Levinthal

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Chronic unexplained nausea and vomiting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Levinthal on 2026-07-24.