Characterization of Gastric Evoked Potentials

NCT05924009 | Recruiting

• 2 other identifiers: STUDY23030127R21NS123502
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Change in GEP hotspot location

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

  Multiple study sessions spanning up to 12 months

• Change in optimal stimulation parameters at GEP hotspot

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

  Multiple study sessions spanning up to 12 months

Secondary Outcomes (2)

• Effect of satiety

  Multiple study sessions spanning up to 12 months

• Effect of neuromodulation

  Multiple study sessions spanning up to 12 months

Study Arms (1)

All participants

EXPERIMENTAL

All participants

Procedure: Transcranial Magnetic Stimulation, TMS

Interventions

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.

All participants

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• David J Levinthal, MD PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul HM Kullmann, PhD

CONTACT

412-647-1533; phmk@pitt.edu

David J Levinthal, MD PhD

CONTACT

412-303-0525; levinthald@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 29, 2023
• Study Start: June 17, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)