Cortical Excitability in Cyclic Vomiting Syndrome
- Conditions
- Cyclic Vomiting Syndrome
- Interventions
- Other: TMS Paired-Pulse assessment of cortical excitabilityOther: Autonomic activity
- Registration Number
- NCT05256160
- Lead Sponsor
- University of Pittsburgh
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- diagnosis of CVS
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CVS subjects TMS Paired-Pulse assessment of cortical excitability Subjects diagnosed with Cyclic Vomiting Syndrome (CVS) CVS subjects Autonomic activity Subjects diagnosed with Cyclic Vomiting Syndrome (CVS) healthy, non-CVS subjects TMS Paired-Pulse assessment of cortical excitability Subjects not diagnosed with CVS healthy, non-CVS subjects Autonomic activity Subjects not diagnosed with CVS
- Primary Outcome Measures
Name Time Method Paired-pulse ratios Multiple study sessions spanning up to 12 months Percentage Change in Paired Pulse (PP) TMS induced MEP responses with inhibitory or facilitatory stimulation.
- Secondary Outcome Measures
Name Time Method TMS motor threshold Multiple study sessions spanning up to 12 months TMS stimulator output necessary to elicit 200 microvolt MEP responses
Cortical silent period Multiple study sessions spanning up to 12 months Length (milliseconds) of EMG inactivity following TMS stimulation
Heart rate variability Multiple study sessions spanning up to 12 months Spectral frequency analysis (via Fast Fourier Transformation) of R-R intervals
Trial Locations
- Locations (1)
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States