[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cyclic-vomiting-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cyclic-vomiting-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100628743","a-study-of-auricular-neurostimulation-for-children-with-cyclic-vomiting-syndrome-100628743",false,"NCT07465614","A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome","Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome: A Randomized, Sham Controlled Trial","Inclusion Criteria:\n\n* Episodic vomiting that meet criteria for CVS based on the 2025 NASPGHAN guidelines for diagnosis of pediatric CVS\n* English-speaking\n* Lack of other explanation for vomiting\n* Intact external ear that is free of infection or severe dermatological conditions\n* Stable stable vital signs for their respective age\n* No currently implanted electrical device\n* Family able to accurately describe symptoms and number of vomiting episodes\n* At least 2 vomiting episodes during the 6 months prior to enrollment\n\nExclusion Criteria:\n\n* Medically complex children or those who take a medication or suffer from another active disease that explain symptoms\n* Children or their parents who have significant developmental delay\n* Participants diagnosed with alternate conditions that explains their symptoms after undergoing medical workup per standard of care\n* Patients with findings of active disease such as intestinal malrotation, peptic ulcer disease, H.pylori gastritis, celiac disease, inflammatory bowel disease, allergic disorders, hydronephrosis, metabolic disorder or any other active chronic condition or medication that may cause of vomiting\n* Patients who are treated with a new drug affecting the central nervous system in the 4 weeks prior to enrollment\n* Pregnancy\n* Severe cardiopulmonary diseases such as chronic obstructive pulmonary disease (COPD) or coronary artery disease\n* Current chronic marijuana use defined as marijuana use \\> 2 times per week over the last 6 months prior to study enrollment\n* Previously treated with a PENFS device","ALL","5 Years","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","Cyclic vomiting syndrome (CVS) is a fairly common disorder characterized by relentless episodes of vomiting followed by return to baseline health.The majority of children with CVS have concurrent severe abdominal pain and migraine-features, causing significant disability during the attacks. There are very few non-drug treatment options for CVS. Many patients are treated with antidepressants that are often ineffective and may cause serious side effects. Emergency room visits and hospitalizations for patients with CVS is extremely high and the syndrome has an immense impact on quality of life. Safe and effective, non-pharmacological therapies for children with CVS are greatly needed.\n\nNausea, vomiting and gastrointestinal pain is modulated by the vagus nerve, an important regulator of the autonomic nervous system. The vagus communicates signals between the gastrointestinal tract and the central nervous system. Many studies indicate that vagal nerve stimulation is effective for various pain and vomiting conditions. Recent studies show that vagus nerve signaling is impaired in children with CVS. Researchers have demonstrated safety and efficacy of auricular percutaneous electrical nerve field stimulation (PENFS) targeting the vagus nerve in a small study of children with CVS. The aim of the current study is to investigate the effects of non-invasive PENFS on CVS episode frequency, duration and severity compared to a sham device in a randomized clinical trial.",[27],"Cyclic Vomiting Syndrome",[29,30,31],"auricular neurostimulation","vagus nerve stimulation","cyclic vomiting syndrome in children","RECRUITING","2026-03-13",{"date":35,"type":36},"2026-03-16","ACTUAL",{"date":38,"type":36},"2026-02-11",{"date":40,"type":21},"2028-12-31",{"name":42,"class":43},"Medical College of Wisconsin","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":18,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":44},"100582430","autonomic-reactivity-and-personalized-neurostimulation-100582430","NCT06863207","Autonomic Reactivity and Personalized Neurostimulation","Autonomic Reactivity to Restore a Dysregulated Brain-Gut Axis Via Targeted Therapy","Inclusion Criteria:\n\n* 11 to 18 years of age\n* English speaking\n* meeting Rome IV diagnostic criteria for cyclic vomiting syndrome or functional dyspepsia and willingness to participate and consent\u002Fassent to the study\n* All subjects will have a constellation of chronic symptoms indicative of autonomic dysfunction for minimum 3 months: postural dizziness\u002Flightheadedness, syncope, palpitations, fatigue, sleep disturbance, thermoregulatory abnormalities and cognitive impairment with upright position +\u002F- abnormal autonomic testing if performed per standard of care as per American Autonomic Society consensus criteria.\n\nExclusion Criteria:\n\n* Presence of organic disease that may explain symptoms\n* Requirement for parenteral nutrition\n* Developmental delays precluding accurate symptom report\n* Severe dermatological condition or active infection of external or middle ear\n* Implanted electrical device\n* Severe mental health disorder not controlled by therapy (schizophrenia, bipolar disease, severe depression, post-traumatic distress disorder) and\u002For psychotic features which could influence symptom report or ANS measurements and result in adverse reactions to hypnosis therapy",true,"FEMALE","11 Years",{"count":20,"type":21},[24],"Disorders of gut-brain interaction (DGBI) affect up to 25% of U.S. children. Patients often suffer from disabling, multisystem comorbidities that suggest a common root (sleep disturbances, fatigue, anxiety, etc). Yet, DGBI are defined and treated based on GI symptom origin (cyclic vomiting, dyspepsia, irritable bowel) rather than underlying pathophysiology. Many patients manifest comorbidities suggesting an underlying autonomic nervous system (ANS) dysregulation (palpitations, dizziness, cognitive dysfunction). Unfortunately, due to common features of anxiety and visceral hyperreactivity and lack of obvious pathology, children with DGBI are frequently diagnosed with psychosomatic or 'benign, functional disorders' and treated with empiric antidepressants despite lack of scientific support and risks of serious side effects. Little is known about the underlying brain-gut mechanisms linking these comorbidities. A lack of targeted treatment options naturally follows the paucity of mechanistic data. A dysregulated ANS response circuit via brainstem nuclei is linked to visceral hypersensitivity. As the team's prior research has shown, ANS regulation can be non-invasively measured via several validated indices of cardiac vagal tone. Using the novel vagal efficiency (VE) metric, the investigators have demonstrated inefficient vagal regulation in cyclic vomiting syndrome and pain-related DGBI and that low VE predicts response to non-invasive, auricular percutaneous electrical nerve field stimulation (PENFS) therapy. PENFS targets brainstem vagal afferent pathways and, along with brain-gut interventions such as hypnotherapy, are the only therapies currently proven effective for pediatric DGBI. Individualizing neurostimulation based on sensory thresholds while assessing dynamic ANS reactivity offers a path towards personalized medicine using the most effective therapies to date. This proposal will test the feasibility of an ANS tracking software in assessing real-time, autonomic regulation and providing individualized neurostimulation in children with nausea\u002Fvomiting and ANS imbalance.",[59,27,60,61],"Functional Gastrointestinal Disorders (FGIDs)","Functional Dyspepsia","Dysautonomia",[63,29,64,65],"autonomic dysfunction","gastric motor function","gut-directed hypnotherapy",{"date":67,"type":36},"2026-02-13",{"date":69,"type":36},"2025-01-24",{"date":71,"type":21},"2029-06",{"name":42,"class":43},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":52,"sex":16,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":44},"100458941","cortical-excitability-in-cyclic-vomiting-syndrome-100458941","NCT05256160","Cortical Excitability in Cyclic Vomiting Syndrome","Inclusion Criteria:\n\n* diagnosis of CVS\n\nExclusion Criteria:\n\n* history of CVS (for healthy control population only)\n* psychosis or altered cognitive status\n* history of head injury, metal in the skull, stroke, or a history of seizures or a history of syncope (fainting or passing out)\n* implantable devices, such as a pacemaker or nerve stimulator\n* 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\u002FPCP, cocaine, or 3 or more alcoholic drinks per day\n* pregnancy","60 Years",{"count":81,"type":21},110,[24],"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).",[27],"2025-08-21",{"date":87,"type":36},"2025-08-24",{"date":89,"type":36},"2022-05-16",{"date":91,"type":21},"2027-06",{"name":93,"class":43},"University of Pittsburgh"]