What is the mechanism of action of this treatment?

Common treatments for psychophysiologic disorders include neurofeedback therapy, mindfulness-based stress reduction (MBSR), and cognitive-behavioral therapy (CBT). Neurofeedback therapy, such as the one studied in the Cereset Research trial, involves training individuals to modulate their brainwave activity, which can enhance autonomic function and improve symptoms of stress, anxiety, and insomnia. MBSR focuses on increasing awareness and self-regulation through meditation practices, which can help manage pain and stress responses. CBT aims to change negative thought patterns and behaviors, thereby reducing symptoms of anxiety and depression. Understanding these mechanisms is crucial for patients as it empowers them to actively participate in their treatment, leading to better management of their symptoms and overall well-being.

What side effects are associated with this type of intervention?

The most common treatments for psychophysiologic disorders, such as cranial electrotherapy stimulation (CES), transcranial magnetic stimulation (TMS), and noninvasive vagus nerve stimulation (nVNS), generally have mild side effects. These include sensations of warmth, tingling, itching, muscle spasms, localized pain, and headaches. Serious adverse events are rare, making these treatments relatively safe for managing conditions like anxiety, depression, and insomnia.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for the treatment of psychophysiologic disorders. Notably, transcranial magnetic stimulation (TMS) has been approved for treating major depressive disorder and migraine with aura. Additionally, cranial electrotherapy stimulation (CES) has been used for anxiety, depression, and insomnia. These treatments, like the neurofeedback therapy studied in the Cereset Research trial, aim to modulate brainwave activity to alleviate symptoms.

What other types of research exist?

Promising novel alternatives to Cereset Research for psychophysiologic disorders include external trigeminal neurostimulation, remote electrical neuromodulation, transcranial magnetic stimulation, and noninvasive vagus nerve stimulation. These therapies have shown efficacy in clinical trials for conditions such as stress, anxiety, and insomnia.

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Not Applicable

Active CR for Stress, Anxiety, and Insomnia

N/A

Recruiting

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 experiencing symptoms of stress, anxiety, or insomnia, who meet threshold scores on one or more self-reported inventories for the same. This includes the Insomnia Severity Index (ISI, ≥ 8), the Perceived Stress Index (PSS, ≥ 14), or the Generalized Anxiety Disorder 7-item (GAD-7, ≥ 5) scale.

Must not have

Weight is over the chair limit (285 pounds)

Prior use of HIRREM, Brainwave Optimization, Cereset, or a wearable configuration of the same (B2, or B2v2)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, v2 (0-14 days after final session), and v3 (4-6 weeks after v2)

Awards & highlights

Summary

This trial is testing a treatment called Cereset Research that uses sounds reflecting brain activity to help people aged 11 or older who have stress, anxiety, or insomnia. The sounds aim to balance the brain and improve automatic body functions.

Who is the study for?

This trial is for individuals experiencing stress, anxiety, or insomnia with certain scores on related self-reported inventories. Participants must be able to follow instructions and sit still with sensor leads attached. Excluded are those over 285 pounds, severe hearing impairment, using alcohol/drugs, or have used similar brainwave technologies recently.

What is being tested?

The study tests Cereset Research (CR), a method aimed at improving autonomic function in people with stress-related symptoms. It involves sitting comfortably while connected to sensor leads that presumably help balance brain rhythms associated with stress and sleep issues.

What are the potential side effects?

Specific side effects of CR are not detailed but may include discomfort from sitting still during sessions or unexpected reactions to the sensory experience. Since it's non-invasive, serious side effects are unlikely compared to drug treatments.

Eligibility Criteria

Inclusion Criteria

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

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I have stress, anxiety, or insomnia with qualifying scores on specific health questionnaires.

Exclusion Criteria

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

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I weigh more than 285 pounds.

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I have used HIRREM, Brainwave Optimization, Cereset, or similar devices.

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I cannot or do not want to give permission for treatment.

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I cannot attend study visits or sit in a chair for 1.5 hours.

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I have a known seizure disorder.

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I have undergone electroconvulsive therapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, v2 (0-14 days after final session), and v3 (4-6 weeks after v2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, v2 (0-14 days after final session), and v3 (4-6 weeks after v2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, v2 (0-14 days after final session), and v3 (4-6 weeks after v2) 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 Baroreflex Sensitivity

Change in Blood Pressure

Change in Blood Pressure Variability

+1 more

Secondary study objectives

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

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

Change in HIRREM Physical Activity Satisfaction Questions

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental: Active CRExperimental Treatment1 Intervention

For this single arm, open label, exploratory trial this will be the intervention arm using active CR.

0 / 7Eligibility 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 psychophysiologic disorders include neurofeedback therapy, mindfulness-based stress reduction (MBSR), and cognitive-behavioral therapy (CBT). Neurofeedback therapy, such as the one studied in the Cereset Research trial, involves training individuals to modulate their brainwave activity, which can enhance autonomic function and improve symptoms of stress, anxiety, and insomnia. MBSR focuses on increasing awareness and self-regulation through meditation practices, which can help manage pain and stress responses. CBT aims to change negative thought patterns and behaviors, thereby reducing symptoms of anxiety and depression. Understanding these mechanisms is crucial for patients as it empowers them to actively participate in their treatment, leading to better management of their symptoms and overall well-being.

A simple and a complex tic (Gilles de la Tourette's syndrome): their response to EEG sensorimotor rhythm biofeedback training.Meta-analysis of randomized controlled trials of cranial electrostimulation. Efficacy in treating selected psychological and physiological conditions.