Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT07276035
Status:
RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain-Stomach Circuits in Chronic Nausea
Sponsor:
David Levinthal
Organization:
Study Overview
Official Title:
TMS Neuromodulation of Brain-to-Stomach Circuits in Chronic Nausea
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01DK144729 | NIH | None | https://reporter.nih.gov/quic… | View |