Status:
WITHDRAWN
Cereset Research For Chronic Nausea
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
The Susanne Marcus Collins Foundation, Inc.
Gastroenterology Project
Conditions:
Nausea
Gastroparesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed 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 ...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05229107
Start Date
March 1 2024
End Date
March 7 2024
Last Update
March 12 2024
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157