Gastric Focused Ultrasound Stimulation

NCT07851727 | Recruiting FDA Device

• 1 other identifier: STUDY00009558
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroparesis; Delayed Gastric Emptying

Keywords

Electrogastrography; Ultrasound; Sham-Controlled Study; Non-invasive Stimulation; Gastric; Gastric stimulation

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

  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.

• 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.

  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.

Study Arms (2)

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.

Device: Gastric Focused Ultrasound Stimulation

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.

Device: Gastric Focused Ultrasound Stimulation

Interventions

Gastric Focused Ultrasound Stimulation DEVICE

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.

Active Gastric Focused Ultrasound Stimulation; Sham Gastric Focused Ultrasound Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 70 years.
• Delayed gastric emptying or gastroparesis diagnosed by a clinician and confirmed by gastric emptying scintigraphy or a gastric emptying breath test.
• Ability to understand the study procedures, provide informed consent, and complete two study visits.
• Ability to consume the two bottles of Ensure or Glucerna nutritional drink used in the study.

You may not qualify if:

• Pregnancy.
• Epilepsy.
• Cardiac pacemaker or another implanted electronic medical device.
• Peritoneal dialysis.
• Daily use of narcotic or opioid medications.
• 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.
• Known allergy or contraindication to the available Ensure or Glucerna nutritional drinks.
• Any other medical or safety condition that, in the judgment of the study team, would make participation unsafe.
• Medication Restrictions:
• Participants 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.

Sponsors & Collaborators

• Evan (Huiliang) Wang: lead

Study Sites (1)

Biomedical Engineering Building

Austin, Texas, 78712, United States

RECRUITING

Related Publications (6)

• Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.

  PMID: 23147521 BACKGROUND

• Cheng LK. Slow wave conduction patterns in the stomach: from Waller's foundations to current challenges. Acta Physiol (Oxf). 2015 Feb;213(2):384-93. doi: 10.1111/apha.12406. Epub 2014 Nov 15.

  PMID: 25313679 BACKGROUND

• O'Grady G, Gharibans AA, Du P, Huizinga JD. The gastric conduction system in health and disease: a translational review. Am J Physiol Gastrointest Liver Physiol. 2021 Nov 1;321(5):G527-G542. doi: 10.1152/ajpgi.00065.2021. Epub 2021 Sep 22.

  PMID: 34549598 BACKGROUND

• Javid A, Ilham S, Kiani M. A Review of Ultrasound Neuromodulation Technologies. IEEE Trans Biomed Circuits Syst. 2023 Oct;17(5):1084-1096. doi: 10.1109/TBCAS.2023.3299750. Epub 2023 Nov 21.

  PMID: 37506009 BACKGROUND

• Bashashati M, Andrews CN, Chen JDZ, McCallum RW, Koch KL. Gastric electrophysiology. Expert Rev Gastroenterol Hepatol. 2026 May;20(5):459-473. doi: 10.1080/17474124.2026.2663975. Epub 2026 Apr 28.

  PMID: 42018791 BACKGROUND

• Song G, Sun Y, Bashashati M, Quezada A, Sigaroodi S, Sarosiek I, Chen JDZ, McCallum RW. Efficacy of needleless transcutaneous electroacupuncture in synchronization with breathing for symptomatic idiopathic gastroparesis: A blinded and controlled acute treatment trial. Neurogastroenterol Motil. 2018 Sep;30(9):e13361. doi: 10.1111/nmo.13361. Epub 2018 May 10.

  PMID: 29745434 BACKGROUND

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Huiliang Wang, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mengmeng Yao, Ph.D.

CONTACT

5732343390; mmyao1102@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: October 1, 2026
• Study Start: September 11, 2026
• Primary Completion (Estimated): June 11, 2027
• Study Completion (Estimated): September 11, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)