Clinical trial NCT05256160: Cortical Excitability in Cyclic Vomiting Syndrome
Official title: Cortical Excitability in Cyclic Vomiting Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cyclic Vomiting Syndrome
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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
* 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

Primary outcomes:
measure: Paired-pulse ratios
timeFrame: Multiple study sessions spanning up to 12 months
Secondary outcomes:
measure: TMS motor threshold
timeFrame: Multiple study sessions spanning up to 12 months
measure: Cortical silent period
timeFrame: Multiple study sessions spanning up to 12 months
measure: Heart rate variability
timeFrame: Multiple study sessions spanning up to 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David J Levinthal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: