Mapping and stimulating brain–stomach connections in chronic nausea
TMS Neuromodulation of Brain-to-Stomach Circuits in Chronic Nausea
This will test whether non-invasive brain stimulation (TMS) can change stomach activity and reduce nausea in adults with chronic nausea and in healthy volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 219 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07276035 on ClinicalTrials.gov |
What this trial studies
The study uses transcranial magnetic stimulation (TMS) while recording stomach electrical activity with surface electrodes (electrogastrogram, EGG) to identify brain sites that influence the stomach. Researchers will map gastric motor-evoked potentials (GMEPs), apply repetitive TMS to identified hotspots, and measure stomach responses during a satiety task (water load or nutrient drink/meal). Participants include adults with chronic nausea and healthy controls who will attend up to ten in-person visits over several months. Clinical, demographic, and autonomic data (for example EKG) will be collected as covariates to interpret differences between groups.
Who should consider this trial
Good fit: Adults aged 21–60 with self-reported chronic nausea and vomiting syndrome or healthy volunteers who meet safety criteria (no implants, no seizure history, BMI ≤30, not pregnant) are ideal candidates.
Not a fit: Patients outside the age or BMI range, those with prior gastric surgery, gastric cancer, neurodegenerative disease, a history of seizures, implantable devices, or on excluded medications (e.g., GLP-1 agonists or drugs that lower seizure threshold) are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this could lead to a non-invasive way to reduce nausea by targeting brain–stomach pathways.
How similar studies have performed: Related work is relatively novel: small prior studies suggest cortical stimulation can alter gastric rhythms, but clinical benefit for chronic nausea has not been established.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: David J Levinthal, MD PhD — University of Pittsburgh
- Study coordinator: Paul HM Kullmann, PhD
- Email: phmk@pitt.edu
- Phone: 412-647-1533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.