Health TrialsbyHealthPanel

Cortical Excitability in Cyclic Vomiting Syndrome

ConditionCyclic Vomiting Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Pittsburgh

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

diagnosis of CVS

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • TMS Paired-Pulse assessment of cortical excitability

    Other intervention

    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 intervention

    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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: CVS subjectsExperimental treatment 2 interventions
Group B: healthy, non-CVS subjectsActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Paired-pulse ratios

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

Time frame
Multiple study sessions spanning up to 12 months

Secondary outcomes

1

TMS motor threshold

TMS stimulator output necessary to elicit 200 microvolt MEP responses

Time frame
Multiple study sessions spanning up to 12 months
2

Cortical silent period

Length (milliseconds) of EMG inactivity following TMS stimulation

Time frame
Multiple study sessions spanning up to 12 months
3

Heart rate variability

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

Time frame
Multiple study sessions spanning up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

Source ClinicalTrials.gov
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