Cortical Excitability in Cyclic Vomiting Syndrome

Cyclic Vomiting Syndrome Clinical Trial

Official title:

Cortical Excitability in Cyclic Vomiting Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05256160
• Other study ID #: STUDY21120001
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2022
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: Paul HM Kullmann, PhD
• Phone: 412-647-1533
• Email: phmk[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cyclic Vomiting Syndrome
• Syndrome
• Vomiting

Intervention

Other:
• TMS Paired-Pulse assessment of cortical excitability
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
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paired-pulse ratios	Percentage Change in Paired Pulse (PP) TMS induced MEP responses with inhibitory or facilitatory stimulation.	Multiple study sessions spanning up to 12 months
Secondary	TMS motor threshold	TMS stimulator output necessary to elicit 200 microvolt MEP responses	Multiple study sessions spanning up to 12 months
Secondary	Cortical silent period	Length (milliseconds) of EMG inactivity following TMS stimulation	Multiple study sessions spanning up to 12 months
Secondary	Heart rate variability	Spectral frequency analysis (via Fast Fourier Transformation) of R-R intervals	Multiple study sessions spanning up to 12 months