Characterization of Gastric Evoked Potentials

Healthy Clinical Trial

Official title:

Characterization of Gastric Evoked Potentials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05924009
• Other study ID #: STUDY23030127
• Secondary ID: R21NS123502
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: July 2026

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: Paul HM Kullmann, PhD
• Phone: 412-647-1533
• Email: phmk[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Effect of satiety	Change in GEP amplitude after water load test	Multiple study sessions spanning up to 12 months
Secondary	Effect of neuromodulation	Change in GEP amplitude when water load test is preceded by rTMS	Multiple study sessions spanning up to 12 months