110 Participants Needed

Non-Invasive Brain Stimulation for Cyclic Vomiting Syndrome

PH
DJ
Overseen ByDavid J Levinthal, MD PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

You may need to stop taking certain medications that lower the seizure threshold, like clozapine, chlorpromazine, amphetamines, and some recreational drugs. The trial does not specify other medications, so check with the study team about your specific situation.

Is non-invasive brain stimulation safe for humans?

Transcranial magnetic stimulation (TMS) is generally safe, but it can cause mild side effects like headaches and nausea. High-frequency TMS can sometimes lead to seizures, and low-frequency TMS may cause nausea, especially when applied to certain brain areas.12345

How does non-invasive brain stimulation differ from other treatments for cyclic vomiting syndrome?

Non-invasive brain stimulation for cyclic vomiting syndrome is unique because it targets brain connectivity and autonomic nervous system regulation, which are linked to the condition's symptoms. Unlike traditional treatments that may focus on gastrointestinal symptoms, this approach aims to modulate brain activity and improve autonomic function, potentially addressing the root cause of the syndrome.678910

What data supports the effectiveness of the treatment for Cyclic Vomiting Syndrome?

Research suggests that Cyclic Vomiting Syndrome (CVS) involves altered brain connectivity and autonomic nervous system function, similar to migraines. Non-invasive brain stimulation, like TMS (transcranial magnetic stimulation), which targets brain areas involved in these processes, has shown promise in treating migraines, indicating potential effectiveness for CVS.68101112

Who Is on the Research Team?

DJ

David J Levinthal, MD PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with cyclic vomiting syndrome (CVS).

Exclusion Criteria

I have a history of head injury, stroke, seizures, or metal in my skull.
I am not using drugs or alcohol that increase my risk of seizures.
Pregnancy
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Transcranial Magnetic Stimulation (TMS) to assess cortical excitability

12 months
Multiple study sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Autonomic activity
  • TMS Paired-Pulse assessment of cortical excitability
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: CVS subjectsExperimental Treatment2 Interventions
Group II: healthy, non-CVS subjectsActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

Published Research Related to This Trial

In a study of 14 pediatric patients with cyclic vomiting syndrome (CVS), it was found that these patients exhibit significantly increased sympathetic modulation of heart rate compared to healthy controls, indicating an autonomic imbalance.
The analysis revealed a low-frequency to high-frequency heart rate variability ratio of 1.45 in CVS patients versus 0.89 in healthy controls, suggesting that CVS is associated with heightened sympathetic activity and reduced parasympathetic activity in the heart.
Evaluation of neurocardiac signals in pediatric patients with cyclic vomiting syndrome through power spectral analysis of heart rate variability.To, J., Issenman, RM., Kamath, MV.[2019]
Cyclic vomiting syndrome (CVS) shows distinct autonomic abnormalities, particularly a low postural adjustment ratio, which is similar to the patterns observed in patients with migraine headaches, suggesting a shared underlying mechanism.
In a study involving 88 participants across five groups, CVS patients exhibited lower cholinergic function compared to normal controls, which may aid in the diagnosis and understanding of CVS.
Autonomic function in cyclic vomiting syndrome and classic migraine.Rashed, H., Abell, TL., Familoni, BO., et al.[2022]
Cyclic Vomiting Syndrome (CVS) is a complex condition often misdiagnosed due to its episodic nature and lack of specific tests, affecting mainly young children but also infants and the elderly.
Management of CVS requires personalized treatment strategies, including supportive care during acute episodes and preventive measures like lifestyle changes, with pharmacotherapy considered based on the severity and impact on quality of life.
Cyclic Vomiting Syndrome in Children.Raucci, U., Borrelli, O., Di Nardo, G., et al.[2020]

Citations

Evaluation of neurocardiac signals in pediatric patients with cyclic vomiting syndrome through power spectral analysis of heart rate variability. [2019]
Autonomic function in cyclic vomiting syndrome and classic migraine. [2022]
Cyclic Vomiting Syndrome in Children. [2020]
Cardiac Vagal Regulation Is Impeded in Children With Cyclic Vomiting Syndrome. [2023]
Cyclic Vomiting Syndrome is characterized by altered functional brain connectivity of the insular cortex: A cross-comparison with migraine and healthy adults. [2018]
Nausea as a complication of low-frequency repetitive transcranial magnetic stimulation of the posterior fossa. [2019]
Immediate cognitive effects of repetitive Transcranial Magnetic Stimulation in eating disorders: a pilot study. [2021]
Reduced motor cortical inhibition in migraine: A blinded transcranial magnetic stimulation study. [2018]
Comparative incidence rates of mild adverse effects to transcranial magnetic stimulation. [2022]
The Effect of Repetitive Transcranial Magnetic Stimulation of Cerebellar Swallowing Cortex on Brain Neural Activities: A Resting-State fMRI Study. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a noninvasive gastric mapping device. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Brain Circuitry Supporting Multi-Organ Autonomic Outflow in Response to Nausea. [2021]
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