Children’s Wisconsin CVS Program is recruiting participants for a clinical trial using auricular neurostimulation with the IB-Stim device. The study is a randomized, double blind trial where some participants receive an active and some receive a sham (inactive) device x 5 consecutive weeks. The study requires weekly device placement on site at Children’s Wisconsin in Milwaukee, Wisconsin. Eligibility needs to be determined by a formal clinical evaluation by a provider in the CVS program.
If interested, contact research coordinator: Rachel Unteutsch phone #: 414-266 4844. Email: runteutsch@mcw.edu
Inclusion Criteria
- Children aged 5-18 years who meet criteria for CVS with at least 2 vomiting episodes in the 6 months prior to enrollment or calendar-timed CVS
- English-speaking
- Lack other explanation for vomiting
- No currently implanted electrical device
- Family able to accurately describe prodrome, symptoms and number of vomiting episodes in the past 6 months
Exclusion criteria
- Medically complex children or those who take a medication or suffer from another active disease that can explain symptoms.
- Children or their parents who have significant developmental delay
- Participants diagnosed with alternate conditions that explains their symptoms
- Cannabinoid hyperemesis syndrome
Finding Clinical Trials
Working toward better treatments for cyclic vomiting syndrome (CVS) requires a collaborative effort between patients and researchers. Because there are currently no medications specifically developed and approved for CVS, participation in clinical trials is essential to bridge the gap in medical knowledge. By joining a study, you can provide the critical data necessary to test new therapies and move closer to finding a cure. Your involvement directly contributes to the development of specialized care that could change the lives of everyone impacted by cyclic vomiting syndrome (CVS).
To find current research opportunities, visit Clinicaltrials.gov and follow these steps:
- Locate the search boxes on the home page.
- In the Condition or disease field, type Cyclic Vomiting Syndrome.
- You can optionally add your city or state in the Location field to find studies nearby.
- Click Search to view a list of active studies, then click on individual trials to see the eligibility criteria and contact information for the research teams.
Why Consider Participating?
While the primary goal of research is to advance medical knowledge, there are several direct benefits for those who choose to get involved:
- Access to Potential New Treatments: You may gain access to new research treatments before they are widely available to the public.
- Expert Medical Care: Participants often receive frequent and closely monitored care from leading physicians and specialists who are experts in the field of Cyclic Vomiting Syndrome.
- Active Role in Health: Joining a trial allows you to take a more proactive role in managing your condition and understanding the science behind your symptoms.
- Contributing to a Cure: You are directly helping the global CVS community by providing the data necessary to move research away from “off label” treatments and toward a dedicated, FDA-approved cure.
- Reduced Costs: Many clinical trials provide the study related medical care and medications at no cost to the participant, and some may offer reimbursement for travel or time.
Important Considerations
*Please Note: Clinical trials are research studies, and participation does not guarantee a specific health outcome or direct benefit. Each trial has its own set of rules regarding who can join and what the study involves. It is important to review the specific details of a study with the research coordinator and your primary healthcare provider to ensure it is a safe and appropriate choice for you.
Questions to Ask Your Doctor or Research Team
If you find a study on Clinicaltrials.gov that interests you, consider bringing these questions to your next appointment or asking the study contact person:
- What is the main goal of this study? Understanding whether the trial is testing a new drug, a device, or a different way of using an existing treatment can help you set expectations.
- What are the potential risks and side effects? Ask how the known side effects of the study treatment compare to your current CVS management plan.
- What tests and procedures are involved? Find out how often you will need to visit the clinic and what types of exams or blood work will be required.
- How long will the trial last? Knowing the time commitment helps you plan for work, school, or travel.
- Who will manage my care during the study? It is helpful to know if you will continue seeing your regular specialist or if the research team will handle your CVS care for the duration of the trial.
- Are there costs involved for me? Ask if the study covers the cost of the medication and if there is reimbursement available for travel or parking.
- What happens if my CVS symptoms flare up during the trial? Ensure there is a clear protocol for how the research team handles acute episodes.
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