Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05924009

Characterization of Gastric Evoked Potentials

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Healthy

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial Magnetic Stimulation, TMS

Procedure

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.

Primary outcomes

  1. Change in GEP hotspot location

    Time frame: Multiple study sessions spanning up to 12 months

    Stimulation location evoking the largest GEP response, relative to FDI hotspot location

  2. Change in optimal stimulation parameters at GEP hotspot

    Time frame: Multiple study sessions spanning up to 12 months

    Stimulation pattern (single pulses or brief bursts) and strength relative to MT for FDI

Secondary outcomes

  1. Effect of satiety

    Time frame: Multiple study sessions spanning up to 12 months

    Change in GEP amplitude after water load test

  2. Effect of neuromodulation

    Time frame: Multiple study sessions spanning up to 12 months

    Change in GEP amplitude when water load test is preceded by rTMS

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2023
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.