ClinicalTrials.gg
RecruitingNCT07276035Updated Jul 24, 2026

Brain-Stomach Circuits in Chronic Nausea

An interventional study of Transcranial Magnetic Stimulation, TMS in Chronic Nausea and Vomiting Syndrome, sponsored by David Levinthal. Recruiting at 1 site in United States. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by David Levinthal · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
219
Allocation
Not applicable
Ages
21 Years to 60 Years
Sex
All
01

Study 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.
Read the detailed description

This study will use cutaneous recordings of stomach activity (electrogastrogram, EGG) and non-invasive brain stimulation with Transcranial Magnetic Stimulation (TMS) to

  1. map descending cerebral cortical-to-stomach circuitry via gastric motor-evoked potentials (GMEPs),
  2. use repetitive TMS (rTMS) applied to GMEP hotspots to modulate the stomach response to a satiety task (water load or nutrient drink/meal),
  3. assess differences in topography and function of cortical-to-stomach circuitry between healthy subjects and subjects suffering from chronic nausea vomiting syndrome (CNVS).

Some clinical, demographic, and autonomic data (i.e. EKG) will be recorded and used as covariates to investigate any systematic impact on the outcome measures.

02

Conditions studied

  • Chronic Nausea and Vomiting Syndrome

Browse trials for

Keywords

  • Chronic unexplained nausea and vomiting
03

In context

Vomiting

793 studies on the registry are indexed under Vomiting; 99 are open to participants now.

This study's planned enrollment of 219 is above the median of 103 across 673 interventional studies indexed under Vomiting.

Browse Vomiting studies →

Lead sponsor

David Levinthal is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • (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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
219 participants (estimated)

Study arms

  • Experimental
    Healthy subjects and CNVS subjects

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

    Device: Transcranial Magnetic Stimulation, TMS

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.

06

What researchers measure

Primary outcomes

  1. GMEP location

    Location of GMEP hotspot(s) in M1 and/or premotor areas relative to FDI hotspot

    Time frame: Baseline session

  2. EGG power change

    Change in spectral power of the EGG in the 3 cpm frequency band associated with the gastric filling task (water load or test meal), either followed or not by neuromodulatory rTMS

    Time frame: Each study session through study completion, up to 1 year

Secondary outcomes

  1. GMEP amplitude

    Amplitude of GMEPs at hotspot

    Time frame: Each study session through study completion, up to 1 year

  2. Volume

    Volume consumed during the gastric filling task

    Time frame: Each study session through study completion, up to 1 year

  3. Nausea severity (only participants suffering from chronic nausea)

    Nausea severity rating on an 11-point (0-10) Likert-scale (0=none, 10=worst possible)

    Time frame: Each study session through study completion, up to 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Final analytic de-identified datasets will be deposited in the SPARC data repository.

Time frame: Datasets will be deposited within 2 years of study completion for as long as the SPARC repository is active.

Access criteria: The SPARC repository is publicly accessible.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2026 (actual). Primary completion is estimated for Jul 2030, 54 months after the start.

Of 131 non-industry interventional studies with no phase under Vomiting, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 29. This study's planned 54 months is above that.

Counting every sponsor, half of 134 studies reached it within 13 months; a quarter within 6 and three quarters within 31.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2025
First posted
Dec 10, 2025
StartActual
Jan 28, 2026
Primary completionEst.
Jul 2030
CompletionEst.
Jul 2031
Last update
Jul 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07276035
Lead sponsor
David Levinthal
Responsible party
David Levinthal (Associate Professor, University of Pittsburgh) — Sponsor-investigator
First posted
Dec 10, 2025
Start date
Jan 28, 2026
Primary completion
Jul 2030 (estimated)
Completion
Jul 2031 (estimated)
Last update
Jul 24, 2026

Study contacts

Elijah D Wright
Contact
edw87@pitt.edu
412-647-1228
David J Levinthal, MD PhD
Contact
levinthald@upmc.edu
412-303-0525
David J Levinthal, MD PhD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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