What is the mechanism of action of this treatment?

Neurofeedback technology, such as Cereset, works by providing real-time feedback on brainwave activity, enabling individuals to self-regulate and optimize their brain function. This is particularly beneficial for healthcare workers who face high stress and burnout. By enhancing cognitive performance and emotional regulation, neurofeedback helps improve overall well-being, allowing healthcare workers to better manage their demanding responsibilities and maintain their mental health.

What side effects are associated with this type of intervention?

Common treatments for conditions such as stress, anxiety, and sleep disorders, which are similar to those addressed by neurofeedback technology, include pharmacotherapy, cognitive-behavioral therapy (CBT), and other mind-body therapies. Pharmacotherapy, such as the use of sedating antidepressants, can lead to side effects like daytime sleepiness, dizziness, headache, and nausea. Cognitive-behavioral therapy and other mind-body therapies generally have fewer side effects but may include temporary increases in anxiety or emotional discomfort as patients confront challenging thoughts and behaviors.

What prior FDA approvals exist?

There is limited specific information on FDA approvals for treatments targeting healthcare workers using neurofeedback technology. However, neurofeedback, a type of biofeedback that uses real-time monitoring of brain activity to teach self-regulation of brain function, has been explored for various conditions such as anxiety, depression, and PTSD. Devices like the NeuroStar TMS (transcranial magnetic stimulation) system have received FDA approval for treatment-resistant depression, which may be relevant for healthcare workers experiencing high levels of stress or burnout. While direct FDA approvals for healthcare worker-specific treatments using neurofeedback are not well-documented, the broader application of neurofeedback and related technologies in mental health treatment is recognized.

What other types of research exist?

Promising novel alternatives to Cereset Research for healthcare workers in 2024 include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in various psychiatric conditions; 2) Cognitive Behavioral Therapy (CBT), particularly for stress and pain management; 3) Pharmacological options like new-generation antidepressants or anxiolytics; 4) Mind-body techniques such as mindfulness-based stress reduction (MBSR) and yoga; 5) Machine-learning guided personalized treatment plans for chronic pain and mental health conditions.

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Behavioural Intervention

Cereset Intervention for Stress and Anxiety (LT-HW Trial)

N/A

Recruiting

Led By Charles H 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to year 1

Awards & highlights

Summary

This trial tests if regular Cereset sessions can help healthcare workers reduce stress after COVID-19. The treatment uses sound to help the brain relax and reset itself. The goal is to see if these sessions can lower stress levels compared to usual care.

Who is the study for?

This trial is for healthcare workers over 18 who feel stressed (PSS score ≥ 14), can follow instructions, sit still for sessions, and commit to a year-long study. It's not for those without internet, severe hearing issues, over 400 pounds, using certain brain therapies recently or enrolled in another study.

What is being tested?

The trial tests long-term effects of 'Cereset Research', an acoustic stimulation therapy after initial sessions versus usual care. Participants are randomly assigned to either continue with the therapy or receive standard care after their first four sessions.

What are the potential side effects?

Since this intervention involves non-invasive acoustic stimulation, side effects may be minimal but could include discomfort from wearing earbuds or sitting still during sessions. Specific side effects aren't detailed but would likely relate to sensory experiences.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to year 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to year 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to year 1 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 Perceived Stress Scale (PSS) scores

Secondary study objectives

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

Change in Insomnia Severity Index (ISI) scores

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cereset Research Control GroupExperimental Treatment1 Intervention

All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will continue their current care for 1 year with no additional CR sessions.

Group II: Cereset Research Tune-Up Intervention GroupActive Control1 Intervention

All study participants will receive 4 initial CR sessions. Afterwards, they will be randomized, and this group will receive an additional tune-up (maintenance) session every 6 weeks for one year. There will be a CR session at weeks 6, 12, 18, 24, 30, 36, 42, and 48.

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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

Neurofeedback technology, such as Cereset, works by providing real-time feedback on brainwave activity, enabling individuals to self-regulate and optimize their brain function. This is particularly beneficial for healthcare workers who face high stress and burnout. By enhancing cognitive performance and emotional regulation, neurofeedback helps improve overall well-being, allowing healthcare workers to better manage their demanding responsibilities and maintain their mental health.

A mindfulness-based stress management program for caregivers of allogeneic hematopoietic stem cell transplant (HCT) patients: Protocol for a randomized controlled trial.Recovering together: building resiliency in dyads of stroke patients and their caregivers at risk for chronic emotional distress; a feasibility study.

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,253 Previous Clinical Trials

1,010,842 Total Patients Enrolled

Susanne Marcus Collins Foundation, Inc.UNKNOWN

1 Previous Clinical Trials

30 Total Patients Enrolled

Charles H Tegeler, MDPrincipal InvestigatorWake Forest University Health Sciences

6 Previous Clinical Trials

528 Total Patients Enrolled

Media Library

Cereset Research (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05994261 — N/A

Acoustic Stimulation Research Study Groups: Cereset Research Tune-Up Intervention Group, Cereset Research Control Group

Acoustic Stimulation Clinical Trial 2023: Cereset Research Highlights & Side Effects. Trial Name: NCT05994261 — N/A

Cereset Research (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05994261 — N/A

~8 spots leftby Nov 2024

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