What side effects are associated with this type of intervention?

Heart Rate Variability (HRV) biofeedback and neurofeedback, including treatments like Brainwave Feedback Neuromodulation, are generally associated with minimal side effects. Mild adverse events may include sensations such as warmth, tingling, or mild discomfort at the site of stimulation. In rare cases, users might experience transient headaches or dizziness. Overall, these treatments are considered safe with no serious adverse events reported.

What prior FDA approvals exist?

The FDA has approved various treatments for heart rate variability (HRV), primarily focusing on pharmacologic agents and devices. Beta-adrenergic blockers like metoprolol and esmolol are commonly used to manage HRV by reducing sympathetic nervous system activity. Additionally, neuromodulation devices such as transcutaneous electrical nerve stimulation (TENS) and vagus nerve stimulation (VNS) have shown promise in influencing HRV. While specific FDA approvals for brainwave feedback neuromodulation, as studied in the Cereset Research trial, are not detailed, these neuromodulation techniques represent a similar approach by targeting the nervous system to regulate heart rate.

What other types of research exist?

Promising novel alternatives to Cereset Research for HRV patients include: 1) External trigeminal neurostimulation (eTNS), which has shown efficacy in acute migraine therapy and may improve autonomic function. 2) Noninvasive vagus nerve stimulation (nVNS), which has been studied for both acute and preventive treatment of migraines and may positively affect HRV. 3) Remote electrical neuromodulation (REN), which has demonstrated benefits in migraine relief and could potentially enhance HRV through autonomic modulation.

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Cereset for Gastroparesis

N/A

Waitlist Available

Led By Charles Tegeler, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with chronic drug- refractory, nausea and vomiting (ages 18 and up)

Stable gastrointestinal symptoms with total GCSI score of greater than or equal to 21

Must not have

Prior use of: HIRREM, HIRREM-SOP, Brainwave Optimization (BWO), Cereset, Cereset Home, or a wearable configuration of the same (B2, or B2v2)

Use of narcotics more than three days per week or other drugs that affect motility (that cannot be held)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a sound-based system called CR to help adults with gastroparesis who suffer from chronic nausea. The system plays back brainwaves through earbuds to help the brain relax and reset itself. The goal is to see if this can reduce their symptoms.

Who is the study for?

This trial is for adults with chronic nausea and vomiting due to gastroparesis, who have not responded well to drugs. They should have a specific score on the GCSI, confirmed gastric emptying status, and meet Rome-IV criteria. Participants must be able to follow instructions, sit still during sessions, and commit to study procedures. Exclusions include other GI disorders that could explain symptoms, significant liver injury or comorbid conditions like heart disease or malignancy.

What is being tested?

The Cereset Research intervention is being tested in this study for its effectiveness in treating refractory chronic nausea in patients with gastroparesis. The trial randomly assigns participants to receive either the Cereset treatment or a control condition.

What are the potential side effects?

While specific side effects of Cereset are not detailed here, it's important for participants to note any discomforts such as difficulty sitting still for long periods or using earbuds required by the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with ongoing nausea and vomiting that doesn't improve with medication.

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My stomach issues have been stable, and my symptom score is 21 or higher.

Select...

I am 18 or older with ongoing nausea and vomiting that doesn't improve with medication.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously used HIRREM, BWO, Cereset, or similar brainwave optimization technologies.

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I use pain medication more than three days a week or take drugs that affect movement.

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My liver tests (ALT, AST, bilirubin) are not normal.

Select...

My weight is over 400 pounds.

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I have a history of fainting or sudden drops in blood pressure.

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I have not had thoughts of suicide in the last 3 months.

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I cannot attend study visits or sit comfortably for up to 1.5 hours.

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I am unable to give consent for medical procedures.

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I have had seizures or a seizure disorder in the last year.

Select...

I am currently taking beta blockers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Gastroparesis Cardinal Symptom Index (GCSI) scores

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

Secondary study objectives

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

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

Change in Nausea Profile (NP) scores

Other study objectives

Body Weight Changes

Change in Fatigue Severity Scale (FSS) scores

Change in Heart Rate (HR)

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Cereset ResearchActive Control1 Intervention

Intervention arm using 6 CR sessions

Group II: Continued Current CareActive Control1 Intervention

Participants will continue their current care.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for improving Heart Rate Variability (HRV) include biofeedback, neurofeedback, and mindfulness-based therapies. Biofeedback and neurofeedback involve training individuals to control physiological processes, such as heart rate, by providing real-time feedback on their biological signals. These methods help enhance autonomic regulation and improve HRV by promoting relaxation and reducing stress. Mindfulness-based therapies, which include meditation and cognitive training, aim to increase awareness and acceptance of present-moment experiences, thereby reducing stress and improving HRV. These treatments are important for HRV patients as they can lead to better autonomic balance, reduced cardiovascular risk, and overall improved heart health.

Efficacy of bio- and neurofeedback for depression: a meta-analysis.Advances in heart rate variability signal analysis: joint position statement by the e-Cardiology ESC Working Group and the European Heart Rhythm Association co-endorsed by the Asia Pacific Heart Rhythm Society.