Cereset for Gastroparesis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test Cereset Research, a non-invasive therapy, to determine its effectiveness in reducing chronic nausea and vomiting in people with gastroparesis, a condition that slows stomach emptying. Participants will either receive Cereset sessions or continue their current care, enabling researchers to compare the effects. This trial suits those who have tried other medications without success and continue to experience nausea and vomiting due to gastroparesis. As an unphased trial, it provides a unique opportunity for patients to explore innovative treatment options beyond standard care.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those using narcotics more than three days a week or drugs affecting motility that cannot be paused. It also excludes those using beta blockers.
What prior data suggests that Cereset Research is safe for treating gastroparesis symptoms?
Research shows that Cereset Research is generally well-tolerated by patients. Previous studies suggest that any side effects, such as nausea and vomiting, are manageable. Although specific data on side effects is not available, the treatment's use suggests it is safe for people. The trial phase is labeled "Not Applicable," often indicating limited specific safety data. However, this suggests the treatment is considered safe enough for testing with participants. Participants are encouraged to discuss any concerns with their healthcare providers before joining the trial.12345
Why are researchers excited about this trial?
Unlike the standard treatments for gastroparesis, which often involve medications to stimulate stomach muscles or alter gut motility, Cereset is unique because it uses a non-invasive neuromodulation technique. This approach involves six sessions of a specialized technology that helps the brain reset its neural patterns, potentially influencing digestive processes indirectly. Researchers are excited about Cereset because it offers a drug-free alternative that could reduce symptoms without the side effects commonly associated with traditional medications. Additionally, this method may provide a new avenue for managing gastroparesis by addressing the condition from a neurological perspective, rather than solely focusing on the gastrointestinal system.
What evidence suggests that Cereset Research is effective for gastroparesis?
Researchers are investigating Cereset Research, a system that uses sound, to determine its effectiveness for people with gastroparesis, particularly those experiencing ongoing nausea. Participants in this trial will either undergo the Cereset intervention, which consists of six sessions, or continue their current care. Specific results on Cereset's effectiveness for gastroparesis are not yet available, but the treatment aims to use sound to promote relaxation and potentially reduce symptoms. This method differs from other treatments like gastric electrical stimulation, which has already helped many patients feel better. The hope is that Cereset might offer similar benefits through a non-invasive approach. More information will become available once the current study concludes.15678
Who Is on the Research Team?
Charles Tegeler, MD
Principal Investigator
Wake Forest University Health Sciences
Are You a Good Fit for This Trial?
This trial is for adults with chronic nausea and vomiting due to gastroparesis, who have not responded well to drugs. They should have a specific score on the GCSI, confirmed gastric emptying status, and meet Rome-IV criteria. Participants must be able to follow instructions, sit still during sessions, and commit to study procedures. Exclusions include other GI disorders that could explain symptoms, significant liver injury or comorbid conditions like heart disease or malignancy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in the Early Intervention group receive 6 Cereset Research sessions over 4 weeks
Control
Participants in the Delayed Intervention group continue their current care without additional intervention
Follow-up
Participants are monitored for changes in various health metrics, including BRS, PAGI-SYM, and GCSI scores
What Are the Treatments Tested in This Trial?
Interventions
- Cereset Research
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor
The Susanne Marcus Collins Foundation, Inc.
Collaborator
Susanne Marcus Collins Foundation
Collaborator
Gastroenterology Project
Collaborator