Characterization of Gastric Evoked Potentials

Not Applicable

Recruiting

• Conditions: Healthy
• Interventions: Procedure: Transcranial Magnetic Stimulation, TMS

• Registration Number: NCT05924009
• Lead Sponsor: University of Pittsburgh

Brief 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.

Study Timeline

• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-06-26
• Study First Posted: 2023-06-29
• Study Start: 2023-07-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 155

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Transcranial Magnetic Stimulation, TMS	All participants

Primary Outcome Measures

Name	Time	Method
Change in GEP hotspot location	Multiple study sessions spanning up to 12 months	Stimulation location evoking the largest GEP response, relative to FDI hotspot location
Change in optimal stimulation parameters at GEP hotspot	Multiple study sessions spanning up to 12 months	Stimulation pattern (single pulses or brief bursts) and strength relative to MT for FDI

Secondary Outcome Measures

Name	Time	Method
Effect of satiety	Multiple study sessions spanning up to 12 months	Change in GEP amplitude after water load test
Effect of neuromodulation	Multiple study sessions spanning up to 12 months	Change in GEP amplitude when water load test is preceded by rTMS

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States