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Cortical Excitability in Cyclic Vomiting Syndrome

Cortical Excitability in Cyclic Vomiting Syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05256160
Enrollment
110
Registered
2022-02-25
Start date
2022-05-16
Completion date
2027-06-01
Last updated
2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cyclic Vomiting Syndrome

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).

Detailed description

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.

Interventions

OTHERTMS 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).

OTHERAutonomic 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.

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Paired-pulse ratiosMultiple study sessions spanning up to 12 monthsPercentage Change in Paired Pulse (PP) TMS induced MEP responses with inhibitory or facilitatory stimulation.

Secondary

MeasureTime frameDescription
TMS motor thresholdMultiple study sessions spanning up to 12 monthsTMS stimulator output necessary to elicit 200 microvolt MEP responses
Cortical silent periodMultiple study sessions spanning up to 12 monthsLength (milliseconds) of EMG inactivity following TMS stimulation
Heart rate variabilityMultiple study sessions spanning up to 12 monthsSpectral frequency analysis (via Fast Fourier Transformation) of R-R intervals

Countries

United States

Contacts

CONTACTElijah D Wright
edw87@pitt.edu412-647-1228
CONTACTDavid J Levinthal, MD PhD
levinthald@upmc.edu412-303-0525
PRINCIPAL_INVESTIGATORDavid J Levinthal, MD PhD

University of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026