WithdrawnNot Applicable

Cereset Research For Chronic Nausea

Stopped: Both Co-PI, Dr. Ken Koch and Dr. Rajeski, have both left the institution, so we have not been able to receive referrals since their departure.

United States0Started 2024-03

Plain-language summary

This study will explore the use of Cereset Research for symptoms associated with refractory chronic nausea in patients with gastroparesis (GP) in a randomized, clinical trial.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects with chronic drug- refractory, nausea and vomiting (ages 18 and up) * Solid-phase gastric emptying studies show either normal gastric emptying or delayed gastric emptying * Referring physician will confirm eligibility based on Rome-IV criteria * Normal upper endoscopy or upper GI series and normal gallbladder tests * Stable gastrointestinal symptoms with total GCSI score of greater than or equal to 21 * Ability to sign informed consent * Ability to comply with basic instructions and be able to sit still, comfortably during sessions * Willingness to complete the EGG and WLST Exclusion Criteria: * Non-gastrointestinal disorders which could explain symptoms in the opinion of the investigator * Active H pylori infection * Significant hepatic injury (elevated ALT, AST, bilirubin) * Metabolic, mechanical, or mucosal inflammatory causes to explain GI symptoms such as inflammatory bowel disease, celiac disease, liver or pancreatic disease, or bowel obstruction * Patients with significant cardiac or cardiovascular disease, malignancy, or other comorbid conditions * Use of narcotics more than three days per week or other drugs that affect motility (that cannot be held) * Previous diagnosis or history of neurocardiogenic syncope, orthostatic hypotension, etc. * Patients with pace makers * Use of beta blockers which can interfere with heart rate variability recording * Unable, unwilling, or incompetent to provide informed consent/assent * Physically unab…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Gastroparesis Cardinal Symptom Index (GCSI) scores

Timeframe: Baseline to V3 (8-10 weeks following completion of the intervention for EI; Baseline to V5 (8-10 weeks following completion of the intervention for DI)

Change in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGY-SYM) scores

Timeframe: Baseline to V3 (8-10 weeks following completion of the intervention for EI; Baseline to V5 (8-10 weeks following completion of the intervention for DI)

Trial details

NCT IDNCT05229107

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-07

View on ClinicalTrials.gov More Nausea trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Gastroparesis Cardinal Symptom Index (GCSI) scores

Timeframe: Baseline to V3 (8-10 weeks following completion of the intervention for EI; Baseline to V5 (8-10 weeks following completion of the intervention for DI)

Change in Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGY-SYM) scores

Timeframe: Baseline to V3 (8-10 weeks following completion of the intervention for EI; Baseline to V5 (8-10 weeks following completion of the intervention for DI)