Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID05256160

Cortical Excitability in Cyclic Vomiting Syndrome

Led by University of Pittsburgh ยท Updated on 2025-08-24

110

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying differences in brain activity between people with cyclic vomiting syndrome (CVS) and healthy individuals. This exploratory study uses a non-invasive brain stimulation technique called Transcranial Magnetic Stimulation (TMS) to assess how the brain's cortex responds in these two groups. The goal is to understand cortical excitability patterns in CVS compared to healthy controls. The study involves stimulating the motor cortex with paired-pulse TMS, which measures the brain's response through muscle activity. Different timing intervals between pulses are used to evaluate various types of brain inhibition and facilitation. The study includes two groups: participants diagnosed with CVS and healthy control subjects without CVS. Autonomic function is also monitored using continuous EKG recordings to see how it might affect brain excitability. Participants will attend multiple study sessions over up to 12 months where brain and heart activity will be assessed. Measurements include paired-pulse ratios, motor thresholds, cortical silent periods, and heart rate variability. Clinical, demographic, and autonomic data will be collected to analyze their relationship with brain excitability. The study aims to gather detailed information about brain function in CVS while monitoring participant health throughout the study period.

CONDITIONS

Brief Title

Cortical Excitability in Cyclic Vomiting Syndrome

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of cyclic vomiting syndrome (CVS)
Not Eligible

You will not qualify if you...

  • History of cyclic vomiting syndrome for healthy control participants only
  • Psychosis or altered cognitive status
  • History of head injury, metal in the skull, stroke, seizures, or syncope (fainting or passing out)
  • Presence of implantable devices such as pacemakers or nerve stimulators
  • Current use of medications or substances known to lower seizure threshold, including clozapine, chlorpromazine, amphetamines, methamphetamine, Ecstasy, Ketamine, PCP, cocaine, or consuming 3 or more alcoholic drinks per day
  • Pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - Multiple study sessions spanning up to 12 months

Participants undergo Transcranial Magnetic Stimulation (TMS) paired-pulse assessments to measure cortical excitability and electromyographic responses, along with autonomic activity monitoring using EKG.

Multiple visits over 12 months

Trial Site Locations

Total: 1 location

1

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

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Research Team

P

Paul HM Kullmann, PhD

D

David J Levinthal, MD PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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