NCT05924009

Characterization of Gastric Evoked Potentials

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 155 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is an exploratory study that will determine and standardize how best to record gastric evoked potentials (GEPs) elicited by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS), by optimizing the TMS parameters and cortical sites necessary to evoke GEPs.

Detailed description

The overall goal of this exploratory study is to determine the optimal conditions to elicit gastric evoked potentials (GEPs) with Transcranial Magnetic Stimulation (TMS). Aim 1: Determine the optimal stimulation parameters and the optimal location for eliciting GEPs in cortical motor areas. Aim 2: Determine whether various modes of repetitive TMS (rTMS) neuromodulation targeted to GEP hotspots shape gastric motor responses to a water load. The investigators will record some clinical, demographic, and autonomic data (i.e. EKG) in our enrolled subjects. Secondary analyses will use these variables as covariates to investigate any systematic impact on the measures from Aims 1 and 2.

Conditions

• Healthy

Interventions

Type	Name	Description
PROCEDURE	Transcranial Magnetic Stimulation, TMS	The best location for evoking an electromyographic (EMG) response of the first dorsal interosseus (FDI) muscle in the dominant hand and the minimum stimulation intensity required to evoke a certain EMG response amplitude (Motor Threshold, MT) are used as reference to determine the best location and stimulation parameters to evoke GEPs. After identification of the GEP hot-spot, a water load test is administered to determine whether satiety shapes GEP responses. In subsequent study visits, the water load test is preceded by application of neuromodulatory repetitive TMS (rTMS), targeted to the GEP hotspot.

Timeline

• Start date: 2023-06-17
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2023-06-29
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States