Exploring brain activity differences in cyclic vomiting syndrome
Cortical Excitability in Cyclic Vomiting Syndrome
This study is testing how brain activity differs in people with cyclic vomiting syndrome compared to healthy individuals to better understand the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT05256160 on ClinicalTrials.gov |
What this trial studies
This exploratory study aims to assess differences in cortical excitability between patients with cyclic vomiting syndrome (CVS) and healthy controls using Transcranial Magnetic Stimulation (TMS). The study employs a paired-pulse TMS paradigm to evaluate intracortical inhibition and facilitation of cortical circuitry by stimulating the motor cortex and measuring the electromyographic response of a target muscle. Various inter-stimulus intervals will be utilized to analyze different aspects of cortical processing. Additionally, clinical, demographic, and autonomic data will be collected to investigate their impact on cortical excitability measures.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with cyclic vomiting syndrome.
Not a fit: Patients with a history of CVS who are part of the healthy control population may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the neurological underpinnings of cyclic vomiting syndrome, potentially leading to improved treatment strategies.
How similar studies have performed: While this approach is exploratory, similar studies using TMS have shown promise in understanding neurological conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 or a history of syncope (fainting or passing out) * 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
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: David J Levinthal, MD PhD — University of Pittsburgh
- Study coordinator: Paul HM Kullmann, PhD
- Email: phmk@pitt.edu
- Phone: 412-647-1533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.