Cortical Excitability in Cyclic Vomiting Syndrome

NCT05256160 | Recruiting

• 1 other identifier: STUDY21120001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

This exploratory study will determine if there are differences in cortical excitability between patients suffering from cyclic vomiting syndrome (CVS) and healthy control subjects, as assessed by a non-invasive method of brain stimulation (Transcranial Magnetic Stimulation, TMS).

Conditions

Cyclic Vomiting Syndrome

Outcome Measures

Primary Outcomes (1)

• Paired-pulse ratios

  Percentage Change in Paired Pulse (PP) TMS induced MEP responses with inhibitory or facilitatory stimulation.

  Multiple study sessions spanning up to 12 months

Secondary Outcomes (3)

• TMS motor threshold

  Multiple study sessions spanning up to 12 months

• Cortical silent period

  Multiple study sessions spanning up to 12 months

• Heart rate variability

  Multiple study sessions spanning up to 12 months

Study Arms (2)

CVS subjects

EXPERIMENTAL

Subjects diagnosed with Cyclic Vomiting Syndrome (CVS)

Other: TMS Paired-Pulse assessment of cortical excitability; Other: Autonomic activity

healthy, non-CVS subjects

ACTIVE COMPARATOR

Subjects not diagnosed with CVS

Other: TMS Paired-Pulse assessment of cortical excitability; Other: Autonomic activity

Interventions

TMS Paired-Pulse assessment of cortical excitability OTHER

Using the paired-pulse TMS paradigm, intracortical inhibition and facilitation of cortical circuitry will be assessed by stimulating the motor cortex and using the electromyographic (EMG) response of a target muscle as readout. In such studies, a conditioning stimulus modulates the amplitude of the motor-evoked potential (MEP) produced by the test stimulus. Depending on the inter-stimulus interval, effects can be attributed to different aspects of cortical processing. Brief intervals (1-5 ms) will be used to assess short-interval intracortical inhibition (SICI) and short-interval intracortical facilitation (SICF), intermediate intervals (7-20 ms) to assess intracortical facilitation (ICF) and long intervals (50-200 ms) to assess long-interval intracortical inhibition (LICI).

CVS subjects; healthy, non-CVS subjects

Autonomic activity OTHER

Autonomic function will be determined using continuously recorded EKG and used as covariates to investigate any systematic impact on cortical excitability measures collected with the paired-pulse protocols.

CVS subjects; healthy, non-CVS subjects

Eligibility Criteria

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

You may qualify if:

• diagnosis of CVS

You may not qualify if:

• history of CVS (for healthy control population only)
• psychosis or altered cognitive status
• history of head injury, metal in the skull, stroke, or a history of seizures or a history of syncope (fainting or passing out)
• implantable devices, such as a pacemaker or nerve stimulator
• current use of the following medications or use of 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Conditions

Familial cyclic vomiting syndrome

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: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a comparative study looking at differences in electrophysiologic measures of cortical excitability between those with Cyclic Vomiting Syndrome and healthy controls.

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 25, 2022
• Study Start: May 16, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)