Cereset for Gastroparesis

Recruiting at 1 trial location

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Narcotics, Beta blockers

Disqualifiers: Cardiac disease, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

Trial Summary

What is the purpose of this trial?

This trial will test a sound-based system called CR to help adults with gastroparesis who suffer from chronic nausea. The system plays back brainwaves through earbuds to help the brain relax and reset itself. The goal is to see if this can reduce their symptoms.

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.

How is the Cereset treatment different from other treatments for gastroparesis?

Cereset is unique because it uses a non-invasive approach called BrainEcho to help the brain relax and reset, which is different from traditional treatments like gastric electrical stimulation that directly target the stomach. This method may offer a novel way to address symptoms by focusing on brain activity rather than the digestive system itself. ^{1 2 3 4 5}

Research Team

Charles Tegeler, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

I am 18 or older with ongoing nausea and vomiting that doesn't improve with medication.

Tests show that your stomach empties at a normal or slow rate.

Ability to sign informed consent

Exclusion Criteria

You have serious trouble hearing (and will need to use ear buds during the clinical trial).

I have previously used HIRREM, BWO, Cereset, or similar brainwave optimization technologies.

I use pain medication more than three days a week or take drugs that affect movement.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the Early Intervention group receive 6 Cereset Research sessions over 4 weeks

4 weeks

6 sessions

Control

Participants in the Delayed Intervention group continue their current care without additional intervention

4 weeks

Follow-up

Participants are monitored for changes in various health metrics, including BRS, PAGI-SYM, and GCSI scores

8-10 weeks

Treatment Details

Interventions

• Cereset Research

Trial Overview The Cereset Research intervention is being tested in this study for its effectiveness in treating refractory chronic nausea in patients with gastroparesis. The trial randomly assigns participants to receive either the Cereset treatment or a control condition.

Participant Groups

Group I: Cereset Research Active Control 1 Intervention

Intervention arm using 6 CR sessions

Group II: Continued Current Care Active Control 1 Intervention

Participants will continue their current care.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

The Susanne Marcus Collins Foundation, Inc.

Collaborator

Trials

5

Recruited

430+

Susanne Marcus Collins Foundation

Collaborator

Trials

1

Gastroenterology Project

Collaborator

Trials

1

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis: Gastric electrical stimulation for gastroparesis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical response to gastric electrical stimulation in patients with postsurgical gastroparesis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of permanent gastric electrical stimulation for the treatment of gastroparesis and functional dyspepsia in children and adolescents. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Neuroenteric Stimulation for Gastroparesis. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term outcomes of gastric electrical stimulation in children with gastroparesis. [2022]