Cereset Research For Chronic Nausea

Wake Forest University (WFU)

Status

Withdrawn

Conditions

Vomiting

Nausea

Gastroparesis

Quality of Life

Hyperarousal

Heart Rate Variability

Anxiety

Stress

Treatments

Device: Cereset Research

Study type

Interventional

Funder types

Other

Identifiers

NCT05229107

IRB00078418

Details and patient eligibility

About

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.

Full description

Cereset Research (CR) is a noninvasive, close-loop, acoustic stimulation brain feedback system. CR translates brainwaves in real time, echoing them immediately via earbuds. This supports the brain to auto calibrate, self adjust, and relax (acoustic neuromodulation). The brain wave patterns are observed to shift towards improved balance and reduced hyperarousal, getting unstuck from what have become stuck patterns related to trauma and stress. Previous clinical trials using CR, as well as the legacy technology HIRREM, have shown significant benefit to reduce symptoms (stress, anxiety, depression, insomnia, Post-traumatic stress disorder (PTSD), persistent post-concussion symptoms, hot flashes, and others). Improved autonomic nervous system function has also been documented) heart rate variability and variable reflex sensitivity), as well as improved network connectivity on functional Magnetic resonance imaging (MRI) before and after the intervention.

Gastroparesis with normal gastric emptying, and associated chronic nausea, is a challenging clinical condition. There is associated autonomic dysfunction, along with many behavioral symptoms, and effective treatments are lacking. Based on prior studies, there is a reason to believe that CR may have beneficial effects for such patients. This controlled clinical trial will enroll up to 24 adults, age 18 or older, who have symptoms of chronic nausea (due to gastroparesis and who are not taking medications or supplements for management of symptoms) with a goal of 20 to complete the intervention. Participants will be randomly assigned to either an Early Intervention (EI) group which will receive 6 CR sessions over 4 weeks of audible tones echoing current brainwave activity, following enrollment, or a Delayed Intervention (DI) group which will continue current care only and will serve as a control group. Participants in both groups will continue their other current care throughout the study.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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 unable to come to the study visits, or to sit still, comfortably in a chair for up to 1.5 hours
Severe hearing impairment (because the subject will be using ear buds during CR)
Anticipated and ongoing use of alcohol or recreational drugs
Weight is over the chair limit (400 pounds)
Currently enrolled in another active intervention research study
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)
Known seizure disorder or unspecified seizure within the past 12 months
Thoughts of suicide within the last 3 months