Cereset Research For Chronic Nausea
Reason given: 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.
Key facts
- Where
- Winston-Salem, United StatesSee the site
Where in United States
- Wake Forest University Health SciencesWinston-Salem, United StatesNo longer taking part
Trial details
- Who runs it
- Wake Forest University Health Sciences
- Trial code
- NCT05229107
- Record updated
- 12 March 2024
- Original description
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.Read full original descriptionShow less
Randomized Controlled Pilot Trial of Cereset Research For Chronic Nausea
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.
Inclusion: 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: 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; Anticipated and ongoing use of alcohol or recreational drugs; Prior use of: HIRREM, HIRREM-SOP, Brainwave Optimization (BWO), Cereset, Cereset Home, or a wearable configuration of the same (B2, or B2v2); Prior use of the following modalities within one month before enrollment: electroconvulsive therapy (ECT), prior use of transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), alpha stimulation, eye movement desensitization and reprocessing (EMDR), brain spotting, neurofeedback, biofeedback, or deep brain stimulation (DBS); Non-gastrointestinal disorders which could explain symptoms in the opinion of the investigator; Active H pylori infection; 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 beta blockers which can interfere with heart rate variability recording; Severe hearing impairment (because the subject will be using ear buds during CR); Known seizure disorder or unspecified seizure within the past 12 months; Significant hepatic injury (elevated ALT, AST, bilirubin); Patients with pace makers; Unable, unwilling, or incompetent to provide informed consent/assent; Physically unable to come to the study visits, or to sit still, comfortably in a chair for up to 1.5 hours; Weight is over the chair limit (400 pounds); Currently enrolled in another active intervention research study; Thoughts of suicide within the last 3 months.