[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658396":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":31,"studyPopulation":23,"armGroups":32,"interventions":44,"overallOfficials":50,"centralContacts":54,"locations":60,"responsibleParty":78,"collaborators":23,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":47,"officialTitle":86,"acronym":23,"eligibilityCriteria":87,"healthyVolunteers":84,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":23,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":63,"whyStopped":23,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Texas at Austin","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":23},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Change in Gastrointestinal Symptom Severity Measured by Total Symptom Score","The Total Symptom Score is the sum of participant-reported severity ratings for nausea, vomiting, early satiety, bloating, postprandial fullness, and abdominal pain. Each symptom is rated from 0 (absent) to 4 (extremely severe), yielding a total score ranging from 0 to 24; higher scores indicate greater symptom severity. Within-participant change in Total Symptom Score from immediately before stimulation to 30 minutes after completion of active FUS or sham stimulation will be compared between conditions.","Immediately before stimulation and 30 minutes after completion of active FUS or sham stimulation at each study visit.",{"measure":14,"description":15,"timeFrame":16},"Change in Gastric Dominant Frequency Measured by Electrogastrography","Gastric dominant frequency will be derived from electrogastrography (EGG) recordings and reported in cycles per minute (cpm). Within-participant values during active FUS and sham stimulation will be compared.","At each study visit: 10-min fasting baseline; 10-min post-meal recording before active FUS or sham; 10-min recording during active FUS or sham; and 10-min recovery recording immediately after stimulation.",{"measure":18,"description":19,"timeFrame":16},"Change in Gastric EGG Signal Amplitude","Gastric EGG signal amplitude will be derived from EGG recordings and reported in microvolts (µV). Within-participant values during active FUS and sham stimulation will be compared.",{"measure":21,"description":22,"timeFrame":16},"Change in Percentage of Time in Normal Gastric Rhythm","The percentage of analyzable EGG recording time with gastric dominant frequency within the normogastric range of 2 to 4 cycles per minute will be calculated and reported as a percentage. Within-participant values during active FUS and sham stimulation will be compared.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"RANDOMIZED","CROSSOVER","This is a randomized, sham-controlled, within-subject crossover study. Each participant will complete two study visits in randomized order: one visit with active noninvasive gastric focused ultrasound stimulation and one visit with sham stimulation. Study visits will be separated by a washout period of at least 48 hours to reduce potential carryover effects. At each visit, participants will undergo the same fasting preparation, standardized liquid nutritional drink challenge, electrogastrography recording, symptom assessments, and safety monitoring. Each participant will serve as their own control for comparisons of active FUS and sham stimulation.","TREATMENT",{"masking":30,"maskingDescription":23,"whoMasked":23},"NONE","This exploratory pilot study will investigate whether noninvasive gastric focused ultrasound (FUS) stimulation is associated with changes in postprandial gastric electrical activity and gastrointestinal symptoms in adult patients with gastroparesis or clinically significant symptoms of delayed gastric emptying.\n\nA total of 12 participants ages 18 to 70 years will complete two study visits in a randomized crossover design. During one visit, participants will receive active gastric focused ultrasound stimulation; during the other visit, they will receive sham stimulation. The order of active and sham stimulation will be randomized. The two visits will be separated by at least 48 hours to reduce potential carryover effects. When possible, visits will be scheduled at a similar time of day.\n\nParticipants will fast for at least 6 to 8 hours before each visit, except for water and medications permitted by their treating physician. At each visit, nine electrogastrography (EGG) electrodes will be placed on cleaned skin over the upper abdomen and stomach region. Participants will complete approximately 10 minutes of fasting baseline EGG recording, consume up to two bottles of Ensure or Glucerna nutritional drink within approximately 15 minutes as tolerated, and complete approximately 10 minutes of post-meal EGG monitoring.\n\nParticipants will then receive active FUS or sham stimulation according to their randomized visit assignment. Active stimulation will be delivered noninvasively through the abdominal skin over the stomach region using an ultrasound transducer and coupling gel. Active stimulation will use a center frequency of 650 kHz and pulse repetition frequency of 1 kHz. Each pulse will consist of 200 microseconds on and 800 microseconds off, corresponding to a 20% pulse-level duty cycle. Pulsed ultrasound will be delivered in repeated blocks of 500 milliseconds on and 500 milliseconds off throughout a total FUS session of 600 seconds. During the sham condition, transducer placement, coupling gel, device setup, and study procedures will be the same, but no active ultrasound energy will be delivered.\n\nEGG signals will be recorded continuously during stimulation or sham and during approximately 10 minutes of post-stimulation recovery monitoring. Participants will report discomfort, warmth, tingling, nausea, pain, dizziness, or other symptoms. Study procedures may be paused or stopped at any time at the participant's request or if the study team identifies a safety concern.\n\nGastrointestinal symptom severity will be assessed using the Total Symptom Score questionnaire. The Total Symptom Score sums ratings of nausea, vomiting, early satiety, bloating, postprandial fullness, and abdominal pain. Each symptom is rated from 0 to 4, with a total score ranging from 0 to 24; higher scores indicate worse symptom severity. Symptom ratings will be collected at the past-two-week baseline assessment, immediately before stimulation, after meal consumption, immediately after FUS or sham stimulation, and 30 minutes after stimulation completion.\n\nThe study will evaluate EGG signal characteristics, including gastric slow-wave rhythm, dominant frequency, amplitude or power, and percentage of time in normal gastric rhythm, and will compare within-participant changes between active FUS and sham conditions. The study is intended to assess feasibility and preliminary physiological effects and is not designed to establish clinical efficacy.",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Active Gastric Focused Ultrasound Stimulation","EXPERIMENTAL","Participants will receive noninvasive gastric focused ultrasound stimulation during one randomized study visit. Participants will undergo fasting baseline EGG recording, consume up to two bottles of a standardized Ensure or Glucerna nutritional drink as tolerated, complete post-meal EGG monitoring, receive active FUS, and complete recovery EGG monitoring and symptom assessments.",[38],"Device: Gastric Focused Ultrasound Stimulation",{"label":40,"type":41,"description":42,"interventionNames":43},"Sham Gastric Focused Ultrasound Stimulation","SHAM_COMPARATOR","Participants will undergo the same procedures as during the active FUS visit, including fasting baseline EGG recording, standardized Ensure or Glucerna nutritional drink consumption, transducer placement, ultrasound coupling gel application, device setup, post-meal and recovery EGG monitoring, and symptom assessments. No active ultrasound energy will be delivered during the sham condition.",[38],[45],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":23},"DEVICE","Gastric Focused Ultrasound Stimulation","Noninvasive focused ultrasound stimulation will be delivered through the abdominal skin over the stomach region using an ultrasound transducer and coupling gel. Active stimulation will use a center frequency of 650 kHz and a pulse repetition frequency of 1 kHz. Each pulse will consist of 200 microseconds on and 800 microseconds off, corresponding to a 20% pulse-level duty cycle. Pulsed ultrasound will be delivered in repeated blocks of 500 milliseconds on and 500 milliseconds off during a total FUS session of 600 seconds.",[34,40],[51],{"name":52,"affiliation":5,"role":53},"Huiliang Wang, PhD","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":23,"email":59},"Mengmeng Yao, Ph.D.","CONTACT","5732343390","mmyao1102@gmail.com",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Biomedical Engineering Building","RECRUITING","Austin","Texas","78712","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-97.74306,30.26715,{"lat":73,"lon":72},[76],{"name":77,"role":57,"phone":58,"phoneExt":23,"email":59},"Mengmeng Yao",{"type":79,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Evan (Huiliang) Wang","Assistant Professor","100658396","gastric-focused-ultrasound-stimulation-100658396",false,"NCT07851727","Gastric Focused Ultrasound Stimulation for Gastroparesis Patients","Inclusion Criteria:\n\n* Age 18 to 70 years.\n* Delayed gastric emptying or gastroparesis diagnosed by a clinician and confirmed by gastric emptying scintigraphy or a gastric emptying breath test.\n* Ability to understand the study procedures, provide informed consent, and complete two study visits.\n* Ability to consume the two bottles of Ensure or Glucerna nutritional drink used in the study.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Epilepsy.\n* Cardiac pacemaker or another implanted electronic medical device.\n* Peritoneal dialysis.\n* Daily use of narcotic or opioid medications.\n* Abdominal wall ulcers, open wounds, active infection, or significant skin irritation in the area where the electrogastrography electrodes or focused ultrasound transducer will be placed.\n* Known allergy or contraindication to the available Ensure or Glucerna nutritional drinks.\n* Any other medical or safety condition that, in the judgment of the study team, would make participation unsafe.\n\nMedication Restrictions:\n\nParticipants using medications that may significantly affect gastric motility or gastric emptying may be rescheduled if those medications were used within the study-defined restriction period. Relevant medications include opioid analgesics, prokinetic agents, anticholinergic or antispasmodic agents, GLP-1 receptor agonists or related medications, and anti-nausea or antiemetic medications that may affect gastrointestinal function. Participants should not discontinue any medically necessary medication without first consulting their treating physician.","ALL","18 Years","70 Years",{"count":92,"type":93},12,"ESTIMATED","INTERVENTIONAL",[96],"NA","This randomized, sham-controlled crossover pilot study will evaluate whether noninvasive gastric focused ultrasound stimulation is associated with changes in postprandial gastric electrical activity and gastrointestinal symptoms in adults with gastroparesis or delayed gastric emptying. Participants will complete one active FUS visit and one sham-stimulation visit in randomized order, separated by at least 48 hours. At each visit, electrogastrography will be recorded before and after a standardized liquid nutritional drink, during active or sham stimulation, and during recovery. Gastrointestinal symptoms will be assessed at prespecified time points using the Total Symptom Score questionnaire.",[99,100],"Gastroparesis","Delayed Gastric Emptying",[102,103,104,105,106,107],"Electrogastrography","Ultrasound","Sham-Controlled Study","Non-invasive Stimulation","Gastric","Gastric stimulation","2026-09-24",{"date":110,"type":111},"2026-10-01","ACTUAL",{"date":113,"type":93},"2026-09-11",{"date":115,"type":93},"2027-09-11",{"name":80,"class":6},1]