About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy.

Epilepsy.

Cardiac pacemaker or another implanted electronic medical device.

Peritoneal dialysis.

Trial design

Design model

Crossover

Treatments tested in this trial

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.

Treatment groups

12 Participants

are divided into 2 treatment groups

Group A: Active Gastric Focused Ultrasound StimulationExperimental treatment 1 intervention

Group B: Sham Gastric Focused Ultrasound StimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

Immediately before stimulation and 30 minutes after completion of active FUS or sham stimulation at each study visit.

2

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.

Time frame

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.

3

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.

Time frame

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.

4

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.

Time frame

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.

Gastric Focused Ultrasound Stimulation

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts