Clinical trial NCT05229107: Cereset Research For Chronic Nausea
Official title: Randomized Controlled Pilot Trial of Cereset Research For Chronic Nausea
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nausea
Gastroparesis
Stress
Anxiety
Hyperarousal
Quality of Life
Vomiting
Heart Rate Variability
Keywords: nausea
gastroparesis
stress
anxiety
insomnia
quality of life
neurotechnology
autonomic dysregulation
hyperarousal
brain electrical activity
acoustic stimulation
HIRREM
Cereset research
water load satiety testing
Electrogastrography
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: The Susanne Marcus Collins Foundation, Inc.
name: Gastroenterology Project
First posted: 2022-02-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a single site, open label, randomized, wait-list controlled, pilot clinical trial. This study 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.
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
measure: 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)
Secondary outcomes:
measure: Change in Nausea Profile (NP) 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)
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D) 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)
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) 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)
Other outcomes:
measure: Change in Severity of Insomnia (ISI) 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)
measure: Change in Post-traumatic stress disorder (PTSD) Checklist for civilians (PCL-C) 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)
measure: Change in Perceived Stress Scale (PSS) 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)
measure: Change in Fatigue Severity Scale (FSS) 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)
measure: Change in Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOl) 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)
measure: Changes in European Quality of Life Five Dimension (EQ-5D) 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)
measure: Change in The Interpersonal Support Evaluation List (ISEL-12) 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)
measure: Change in Short Form McGill Pain Questionnaire (MPQ) scores
timeFrame: Baseline to V3 (8-10 weeks following completion of the intervention for EI; 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)
measure: Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Pain Interference questionnaire 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)
measure: Change in Heart Rate Variability (HRV)
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)
measure: Change in Heart Rate (HR)
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)
measure: Change in Baroreflex Sensitivity (BRS)
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)
measure: Changes in Healthcare Utilization Survey
timeFrame: V3 (8-10 weeks following completion of the intervention for EI; V5 (8-10 weeks following completion of the intervention for DI)
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Charles Tegeler, MD
role: PRINCIPAL_INVESTIGATOR
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