Cortical Excitability in Cyclic Vomiting Syndrome

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT05256160
Status
Recruiting
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Conditions

  • Cyclic Vomiting Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

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).
  • 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.

Study Details

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).

Key Dates

Start date
May 16, 2022
Status verified
Aug 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: CVS subjects
    Subjects diagnosed with Cyclic Vomiting Syndrome (CVS)
  • Active Comparator: healthy, non-CVS subjects
    Subjects not diagnosed with CVS

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-

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By research site
University of Pittsburgh Medical Center· Pittsburgh, PA

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