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Non-Invasive Brain Stimulation for Cyclic Vomiting Syndrome

N/A
Recruiting
Led By David J Levinthal, MD PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of CVS
Be between 18 and 65 years old
Must not have
History of head injury, metal in the skull, stroke, or a history of seizures
Current use of medications/substances 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up multiple study sessions spanning up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will see if there are differences in brain activity between people with CVS and healthy people, as measured by a non-invasive brain stimulation method.

Who is the study for?
This trial is for individuals diagnosed with cyclic vomiting syndrome (CVS). It's not open to those who have a history of head injury, metal in the skull, stroke, seizures, or use certain drugs like clozapine or amphetamines. Pregnant women and people with psychosis or cognitive issues can't join either.
What is being tested?
The study is testing how the brain's electrical activity differs between CVS patients and healthy people using Transcranial Magnetic Stimulation (TMS), which is a non-invasive brain stimulation technique.
What are the potential side effects?
Since TMS is non-invasive, side effects are usually mild but may include discomfort at the stimulation site, headache, lightheadedness, or rarely seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with cyclic vomiting syndrome (CVS).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of head injury, stroke, seizures, or metal in my skull.
Select...
I am not using drugs or alcohol that increase my risk of seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~multiple study sessions spanning up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and multiple study sessions spanning up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Paired-pulse ratios
Secondary study objectives
Cortical silent period
Heart rate variability
TMS motor threshold

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CVS subjectsExperimental Treatment2 Interventions
Subjects diagnosed with Cyclic Vomiting Syndrome (CVS)
Group II: healthy, non-CVS subjectsActive Control2 Interventions
Subjects not diagnosed with CVS

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,792 Previous Clinical Trials
16,359,876 Total Patients Enrolled
David J Levinthal, MD PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
155 Total Patients Enrolled

Media Library

Autonomic activity Clinical Trial Eligibility Overview. Trial Name: NCT05256160 — N/A
Cyclic Vomiting Syndrome Research Study Groups: CVS subjects, healthy, non-CVS subjects
Cyclic Vomiting Syndrome Clinical Trial 2023: Autonomic activity Highlights & Side Effects. Trial Name: NCT05256160 — N/A
Autonomic activity 2023 Treatment Timeline for Medical Study. Trial Name: NCT05256160 — N/A
~15 spots leftby Jun 2025
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