Study Summary
This trial is testing a new noninvasive treatment for gastroparesis that uses neuromodulation to improve symptoms. The hypothesis is that this new treatment will be better than a sham treatment at improving symptoms.
- Diabetic Gastroparesis
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 4 weeks
Trial Safety
Phase-Based Safety
Trial Design
3 Treatment Groups
1Hz Arm
1 of 3
10Hz Arm
1 of 3
Sham Arm
1 of 3
Active Control
Non-Treatment Group
48 Total Participants · 3 Treatment Groups
Primary Treatment: 1Hz Arm · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 85 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Massachusetts | 100.0% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| Augusta University | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Frequently Asked Questions
Am I eligible to take part in this research initiative?
"This study has 48 places for outpatients, aged 18-85, with gastroparesis and refractory symptoms. Other criteria include: no known mucosal diseases; fluency in English (as self-reported); and having been on a consistent dose of any medications (excluding psychotropic drugs or opioids) within the previous 30 days - without changes during the trial duration." - Anonymous Online Contributor
To what extent is participation in this research opportunity being limited?
"Affirmative. According to clinicaltrials.gov, the research is open for enrollment and has been since its initial posting on June 27th 2022; it was last edited two days later on June 29th. Currently, 48 patients are required across a single site." - Anonymous Online Contributor
Is this research presently open to enrollment?
"Indeed, the current information hosted on clinicaltrials.gov reveals that recruitment for this medical trial is still ongoing; the study was initially posted on June 27th 2022 and last updated two days later. This research requires 48 individuals from 1 location to take part in it." - Anonymous Online Contributor
Does this experiment have any age restrictions for participating participants?
"This medical experiment has strict age criteria with a lower limit of 18 years old and an upper bound of 85." - Anonymous Online Contributor