Exploring how to record gastric responses using brain stimulation
Characterization of Gastric Evoked Potentials
This study is trying to find the best ways to use brain stimulation to see how the stomach reacts when people drink water.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 155 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05924009 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to determine the optimal conditions for recording gastric evoked potentials (GEPs) using Transcranial Magnetic Stimulation (TMS). The study will focus on identifying the best stimulation parameters and cortical locations to elicit GEPs. Additionally, it will investigate how different modes of repetitive TMS can influence gastric motor responses when subjects consume water. Clinical, demographic, and autonomic data will be collected to analyze their impact on the results.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals without any significant medical history or conditions that could interfere with TMS.
Not a fit: Patients with a history of neurodegenerative disorders, diabetes, or those who have undergone bariatric surgery are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of gastric function and lead to improved treatments for gastrointestinal disorders.
How similar studies have performed: While the approach of using TMS to study gastric responses is innovative, similar studies have shown promise in neuromodulation techniques, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Exclusion Criteria: * psychosis or altered cognitive status * history of head injury, metal in the skull, stroke, or a history of seizures, loss of consciousness or syncope * implantable devices, such as a pacemaker or nerve stimulator * current use of antiepileptic medications or current use of the following medications or substances which are known to lower the seizure threshold: Clozapine (Clozaril), Chlorpromazine (Thorazine), amphetamines or methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or 3 or more alcoholic drinks per day * pregnancy * BMI \> 30 * history of bariatric surgery such as sleeve gastrectomy or Roux-en-Y gastric bypass * diabetes * suffering from a neurodegenerative disorder.
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.