Characterization of Gastric Evoked Potentials

University of Pittsburgh

Status: Enrolling

Conditions: Healthy

Treatments: Procedure: Transcranial Magnetic Stimulation, TMS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05924009

STUDY23030127

R21NS123502 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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155 participants in 1 patient group

All participants

Experimental group

Description:

All participants

Treatment:

Procedure: Transcranial Magnetic Stimulation, TMS