Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT05256160

Conditions

Cyclic Vomiting Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

TMS Paired-Pulse assessment of cortical excitability

Autonomic activity

Study Details

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

Study ID

NCT05256160

Start date

May 16, 2022

Status verified date

Aug, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • diagnosis of CVS

Exclusion Criteria:

  • 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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: CVS subjects

Subjects diagnosed with Cyclic Vomiting Syndrome (CVS)

active comparator: healthy, non-CVS subjects

Subjects not diagnosed with CVS

Interventions

TMS Paired-Pulse assessment of cortical excitability

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).

Autonomic activity

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.

Primary outcome measure

  • Paired-pulse ratios [ Time Frame: Multiple study sessions spanning up to 12 months ]

Central Contacts and Locations

Central contacts

Elijah D Wright

412-647-1228edw87@pitt.edu

David J Levinthal, MD PhD

412-303-0525levinthald@upmc.edu

Locations

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

More Information

Sponsor

University of Pittsburgh

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-08-14.