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Cereset Research For Chronic Nausea

Primary Purpose

Nausea, Gastroparesis, Stress

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cereset Research

About this trial

This is an interventional supportive care trial for Nausea focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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 orthostatic intolerance, e.g. POTS, 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
Thoughts of suicide within the last 3 months

Sites / Locations

Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Cereset Research

Continued Current Care

Arm Description

Intervention arm using 6 CR sessions

Participants will continue their current care.

Outcomes

Primary Outcome Measures

Change in Gastroparesis Cardinal Symptom Index (GCSI) scores

The Gastroparesis Cardinal Symptom Index (GCSI) is a 9-item scale within the Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM).episodes). The severity of symptom response scale ranges from 0 ("none"), 1 ("mild"), 2 ("moderate"), 3 ("severe") to 4 ("very severe"). Score can range from 0 to 4. High scores reflect greater symptom severity.

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

The Patient Assessment of Gastrointestinal Disorders Symptom Severity Index (PAGI-SYM) is 20 items. This inventory includes six subscales of related GI distress including heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Individual item scores range from 0 (none) to 5 (very severe). The higher the score, the more severe the GI symptoms.

Secondary Outcome Measures

Change in Nausea Profile (NP) scores

The Nausea Profile evaluates the experience of 3 dimensions which are involved in the complex feeling of nausea; somatic distress, Gastrointestinal (GI) distress, and emotional distress. The degree to which the patient felt/feels each of the following descriptors during the nauseous period is rated by the patient on a scale of 0 (not at all) to 9 (severely). Higher scores suggest more nausea.

Change in Center for Epidemiologic Studies Depression Scale (CES-D) scores

The Center for Epidemiologic Studies Depression Scale (CES-D) is a depression scale, which will help to assess this co-morbidity. CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. The higher the score, the more suggestive of depressive symptoms.

Change in Generalized Anxiety Disorder-7 (GAD-7) scores

The Generalized Anxiety Disorder-7 (GAD-7) is a seven-item screening tool for anxiety that is widely used in primary care. GAD-7 is a brief, reliable and valid measure of assessing generalized anxiety disorder. A score of 10 or greater on the GAD-7 represents a reasonable cut point for identifying cases. Cut points of 5, 10, and 15 might be interpreted as representing mild, moderate, and severe levels of anxiety.

Full Information

NCT ID

NCT05229107

First Posted

December 28, 2021

Last Updated

September 26, 2023

Sponsor

Wake Forest University Health Sciences

Collaborators

Susanne Marcus Collins Foundation, Gastroenterology Project

1. Study Identification

Unique Protocol Identification Number

NCT05229107

Brief Title

Cereset Research For Chronic Nausea

Official Title

Randomized Controlled Pilot Trial of Cereset Research For Chronic Nausea

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2024 (Anticipated)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

Susanne Marcus Collins Foundation, Gastroenterology Project

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cereset Research

Arm Type

Active Comparator

Arm Description

Intervention arm using 6 CR sessions

Arm Title

Continued Current Care

Arm Type

No Intervention

Arm Description

Participants will continue their current care.

Intervention Type

Device

Intervention Name(s)

Cereset Research

Intervention Description

Device: Cereset Research The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.

Primary Outcome Measure Information:

Title

Change in Gastroparesis Cardinal Symptom Index (GCSI) scores

Description

Time Frame

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)

Title

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

Description

Time Frame

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 Outcome Measure Information:

Title

Change in Nausea Profile (NP) scores

Description

Time Frame

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)

Title

Change in Center for Epidemiologic Studies Depression Scale (CES-D) scores

Description

Time Frame

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)

Title

Change in Generalized Anxiety Disorder-7 (GAD-7) scores

Description

Time Frame

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 Pre-specified Outcome Measures:

Title

Change in Severity of Insomnia (ISI) scores

Description

The ISI is a 7 question, self-reported measure to evaluate symptoms of insomnia, with responses from 0-4 for each question, yielding scores ranging from 0-28. Lower scores represent better outcomes.

Time Frame

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)

Title

Change in Post-traumatic stress disorder (PTSD) Checklist for civilians (PCL-C) scores

Description

The PTSD Checklist for civilians (PCL-C), measures the American Psychiatric Association's Diagnostic and statistical manual of mental disorders (DSM-IV) Criteria B, C, & D of PTSD symptoms based on traumatic life experience either in civilian life. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. Higher scores suggest more traumatic stress.

Time Frame

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)

Title

Change in Perceived Stress Scale (PSS) scores

Description

The Perceived Stress Scale (PSS) is a ten-item psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale, with answers rated from 0-4, also includes a number of direct queries about current levels of experienced stress. Total scores range from 0-40. A lower score denotes a lower level of perceived stress.

Time Frame

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)

Title

Change in Fatigue Severity Scale (FSS) scores

Description

Fatigue Severity Scale (FSS) is a nine-item instrument to assess how fatigue interferes with daily activities. Items are scored on a 7-point scale ranging from 1=strongly disagree to 7=strongly agree. Total scores range from 9 to 63 and the higher the rating demonstrates greater fatigue severity.

Time Frame

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)

Title

Change in Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOl) scores

Description

Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) is a specific scale for how Gastrointestinal (GI) symptoms impact quality of life in those with GI disorders. The scale consists of 30-items scored from 0 (none of the time) to 5 (all of the time) with a recall period of the last 2-weeks. Lower scores suggest better outcomes.

Time Frame

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)

Title

Changes in European Quality of Life Five Dimension (EQ-5D) scores

Description

The self-rating health question from the EQ-5D on a scale of 0-100 (0 = worst imaginable health state, 100 = best imaginable health state) will be administered to get a snapshot of overall health at that point in time.

Time Frame

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)

Title

Change in The Interpersonal Support Evaluation List (ISEL-12) scores

Description

The Interpersonal Support Evaluation List - Shortened Version (ISEL-12) is a 12-item scale that was modified from a 40-item scale used to assess perceptions of social support. Three dimensions are evaluated: appraisal support, belonging support, and tangible support. Each item is scaled from 1 to 4 for "Definitely True" to "Definitely False." Total scores range from 0-36 and higher scores suggest more social support.

Time Frame

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)

Title

Change in Short Form McGill Pain Questionnaire (MPQ) scores

Description

Short Form McGill Pain Questionnaire (MPQ) will be given to those who also report chronic pain. The MPQ is made up of 78 words and scores range from 0 (no pain) to 78 (severe pain).

Time Frame

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)

Title

Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Pain Interference questionnaire scores

Description

The PROMIS Short Form Pain Interference questionnaire will be given too those who report chronic pain. The PROMIS short form is a 6-point Likert-type scale, with scores ranging from 1 (had no pain) to 6 (always) over a 7-day recall period. Higher scores suggest more pain interference

Time Frame

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)

Title

Change in Heart Rate Variability (HRV)

Description

Measures of heart rate variability in frequency domain will be derived and measures integrated over specified frequency ranges.

Time Frame

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)

Title

Change in Heart Rate (HR)

Description

Continuous heart rate will be recorded while participant is breathing normally in seated position for 10 minutes using Faros 180 heart rate monitor (Bittium Corporation, Oulu, Finland). Beat to beat intervals (RRI) files will be generated at 1000 Hz via the data acquisition software. Files will be analyzed with Nevrokard HRV software (by Nevrokard Kiauta, d.o.o., Izola, Slovenia). Recordings will be visually inspected to ensure data quality (dropped beats or gross motion artifacts are excluded) and first 5 minutes of usable tracings will be analyzed.

Time Frame

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)

Title

Change in Baroreflex Sensitivity (BRS)

Description

BRS calculated by this method is based on quantification of sequences of at least three beats (n) in which SBP consecutively increases (UP sequence) or decreases (DOWN sequence), which are accompanied by changes in the same direction of the RRI of subsequent beats (n+1). The software scans the RRI and SBP records, identifies sequences, and calculates linear correlation between RRI and SBP for each sequence. The mean of all individual regression coefficients (slopes), a measure of sequence BRS, is calculated for Sequence UP, DOWN and ALL (ms/mmHg). Blood pressure and heart rate are acquired from 10 minute recordings of noninvasive finger arterial pressure measurements and ECG with participants lying quietly, supine. Systolic BP and beat to beat, RR intervals files generated via the data acquisition system (BIOPAC acquisition system and Acknowledge 4.2 software, Santa Barbara, CA), at 1000 Hz, are analyzed using Nevrokard BRS software (Nevrokard BRS, Medistar, Ljubljana, Slovenia).

Time Frame

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)

Title

Changes in Healthcare Utilization Survey

Description

Clinic visit counts will be collected (ED, Urgent Care visits).

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Study Coordinator

Phone

336-716-9341

BBRP@wakehealth.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Charles Tegeler, MD

Phone

336-716-7651

ctegeler@wakehealth.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles Tegeler, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dawn Higgins

Phone

336-713-9447

dkellar@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD

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