Chronic Nausea and Vomiting SyndromeNCT07276035
Brain-Stomach Circuits in Chronic Nausea
A study testing Transcranial Magnetic Stimulation, TMS in people with Chronic Nausea and Vomiting Syndrome, run by David Levinthal at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Nausea and Vomiting Syndrome
- What is being tested?
- Transcranial Magnetic Stimulation, TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults between ages 21-60 years old, with and without CNVS diagnosis per self-report.
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
About this study
Official title: TMS Neuromodulation of Brain-to-Stomach Circuits in Chronic Nausea
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?
Read more
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
- map descending cerebral cortical-to-stomach circuitry via gastric motor-evoked potentials (GMEPs),
- use repetitive TMS (rTMS) applied to GMEP hotspots to modulate the stomach response to a satiety task (water load or nutrient drink/meal),
- 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.
- Conditions
- Chronic Nausea and Vomiting Syndrome
- Being tested
- Transcranial Magnetic Stimulation, TMS
- Keywords
- Chronic unexplained nausea and vomiting
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation, TMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects and CNVS subjects | Experimental | Subjects without gastric problems and subjects with Chronic Nausea and Vomiting (CNVS) Receives: Device: Transcranial Magnetic Stimulation, TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMEP location
Location of GMEP hotspot(s) in M1 and/or premotor areas relative to FDI hotspot
Measured: Baseline session
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
Measured: Each study session through study completion, up to 1 year
Secondary outcomes (3)
GMEP amplitude
Amplitude of GMEPs at hotspot
Measured: Each study session through study completion, up to 1 year
Volume
Volume consumed during the gastric filling task
Measured: Each study session through study completion, up to 1 year
Nausea severity (only participants suffering from chronic nausea)
Nausea severity rating on an 11-point (0-10) Likert-scale (0=none, 10=worst possible)
Measured: Each study session through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start28 Jan 2026
- Primary completionJul 2030 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nausea and Vomiting SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Levinthal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Levinthal, University of Pittsburgh
- Investigators
- David J Levinthal, MD PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276035
- Sponsor's protocol ID
- STUDY25100001
- Other IDs
- 1R01DK144729
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Final analytic de-identified datasets will be deposited in the SPARC data repository.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMS Neuromodulation of Brain-to-Stomach Circuits in Chronic Nausea
- ClinicalTrials.gov ID
- NCT07276035
- Acronym / sponsor ID
- STUDY25100001
- Conditions
- Chronic Nausea and Vomiting Syndrome
- Keywords
- Chronic unexplained nausea and vomiting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- David LevinthalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will use cutaneous recordings of stomach activity (electrogastrogram, EGG) and non-invasive brain stimulation with Transcranial Magnetic Stimulation (TMS) to
- map descending cerebral cortical-to-stomach circuitry via gastric motor-evoked potentials (GMEPs),
- use repetitive TMS (rTMS) applied to GMEP hotspots to modulate the stomach response to a satiety task (water load or nutrient drink/meal),
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects and CNVS subjects | Experimental | Device: Transcranial Magnetic Stimulation, TMSSubjects without gastric problems and subjects with Chronic Nausea and Vomiting (CNVS) |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults between ages 21-60 years old, with and without CNVS diagnosis per self-report.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation, TMSThe 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. | Device | Healthy subjects and CNVS subjects |
Primary outcome
GMEP location
Time frame: Baseline session
Location of GMEP hotspot(s) in M1 and/or premotor areas relative to FDI hotspot
EGG power change
Time frame: Each study session through study completion, up to 1 year
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
3 secondary outcomes
GMEP amplitude
Time frame: Each study session through study completion, up to 1 year
Volume
Time frame: Each study session through study completion, up to 1 year
Nausea severity (only participants suffering from chronic nausea)
Time frame: Each study session through study completion, up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. Final analytic de-identified datasets will be deposited in the SPARC data repository.
Related trials for Chronic Nausea and Vomiting Syndrome
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Evaluating Whether a Nausea Band Reduces Symptoms in Those With Chronic Nausea Vomiting
Chronic Nausea, Chronic Nausea and Vomiting Syndrome
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Chronic Nausea and Vomiting in Patients With Normal Gastric Emptying Using the Enterra® Therapy System (NAVIGATE)
Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David J Levinthal, MD PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation, TMS in people with Chronic Nausea and Vomiting Syndrome, run by David Levinthal at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elijah D Wright (412-647-1228, edw87@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GMEP location (time frame: Baseline session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.