Cortical Excitability in Cyclic Vomiting Syndrome

Last updated: April 14, 2025
Sponsor: University of Pittsburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vomiting

Bulimia

Treatment

Autonomic activity

TMS Paired-Pulse assessment of cortical excitability

Clinical Study ID

NCT05256160
STUDY21120001
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • diagnosis of CVS

Exclusion

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

  • implantable devices, such as a pacemaker or nerve stimulator

  • current use of the following medications or use of substances which are known tolower the seizure threshold: clozapine (Clozaril), chlorpromazine (Thorazine),amphetamines or methamphetamine, Ecstasy, Ketamine, Angel Dust/PCP, cocaine, or 3 ormore alcoholic drinks per day

  • pregnancy

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Autonomic activity
Phase:
Study Start date:
May 16, 2022
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

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