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NCT Number: NCT05256160

Cortical Excitability in Cyclic Vomiting Syndrome

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).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location status: Recruiting

About this study

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).

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).

Some clinical, demographic, and autonomic data (i.e. EKG) will be recorded and used as covariates to investigate any systematic impact on cortical excitability measures collected with the paired-pulse protocols.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Primary outcomes

  1. Paired-pulse ratios

    Time frame: Multiple study sessions spanning up to 12 months

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

Secondary outcomes

  1. TMS motor threshold

    Time frame: Multiple study sessions spanning up to 12 months

    TMS stimulator output necessary to elicit 200 microvolt MEP responses

  2. Cortical silent period

    Time frame: Multiple study sessions spanning up to 12 months

    Length (milliseconds) of EMG inactivity following TMS stimulation

  3. Heart rate variability

    Time frame: Multiple study sessions spanning up to 12 months

    Spectral frequency analysis (via Fast Fourier Transformation) of R-R intervals

Study contacts

Contact information is provided by the study sponsor or research team.

David J Levinthal, MD PhD

CONTACT

[email protected]

412-303-0525

Paul HM Kullmann, PhD

CONTACT

[email protected]

412-647-1533

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2022
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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