Cortical Excitability in Cyclic Vomiting Syndrome

University of Pittsburgh

Status: Enrolling

Conditions: Cyclic Vomiting Syndrome

Treatments: Other: Autonomic activity; Other: TMS Paired-Pulse assessment of cortical excitability

Study type: Interventional

Funder types: Other

Identifiers

NCT05256160

STUDY21120001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

CVS subjects

Experimental group

Description:

Subjects diagnosed with Cyclic Vomiting Syndrome (CVS)

Treatment:

Other: TMS Paired-Pulse assessment of cortical excitability

Other: Autonomic activity

healthy, non-CVS subjects

Active Comparator group

Description:

Subjects not diagnosed with CVS

Treatment:

Other: TMS Paired-Pulse assessment of cortical excitability

Other: Autonomic activity