Cereset for Caregiver Stress

(CERESET Trial)

Overseen By Study Nurse

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Anti-epileptics

Disqualifiers: Heavy alcohol use, Severe hearing impairment, Weight ≥ 400 pounds, Prior use of TMS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the feasibility of using Cereset, an acoustic stimulation therapy, to help caregivers manage stress. It targets those caring for patients recently diagnosed with high-grade glioma, a type of brain cancer. Participants will undergo five in-office Cereset sessions and use a wearable device for additional therapy during routine radiation sessions. Ideal candidates are primary caregivers who provide most of the support for someone with a high-grade glioma diagnosis. As an unphased trial, this study offers caregivers a unique opportunity to explore innovative stress management techniques.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a seizure disorder requiring ongoing anti-epileptic medication, you may not be eligible to participate.

What prior data suggests that the Cereset intervention is safe for caregivers?

Research shows that the Cereset treatment has been tested in people with conditions like PTSD, insomnia, and stress. Studies have found that Cereset uses sound to help the brain reset, which can be calming. Although specific safety information for caregivers is still being collected, the treatment has been used in other groups without serious problems. Past patients have not reported major side effects. This suggests that Cereset is generally safe, but ongoing studies will provide more detailed safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for caregiver stress, which often involve counseling, medication, or stress management techniques, Cereset offers a unique approach by using brainwave technology. Cereset is a non-invasive therapy that helps the brain rebalance itself through audio tones, potentially providing a calming effect without the need for pharmaceuticals. Researchers are excited about Cereset because it offers a new way to address stress by directly interacting with brain activity, which could lead to quicker and more sustained relief for caregivers under significant stress.

What evidence suggests that the Cereset intervention is effective for caregiver stress?

Research has shown that Cereset, a non-invasive technology, may help reduce stress and improve sleep. Studies have found it can assist people with PTSD, insomnia, and other stress-related issues. Early findings suggest that Cereset lowers stress by using sound to balance brain activity. In this trial, caregivers of participants with high-grade glioma will undergo Cereset treatment. Similar methods have greatly reduced stress levels over a few months in previous studies. While more research is needed, early results are promising for those feeling overwhelmed by caregiving duties. ^{1 2 3 4 6}

Who Is on the Research Team?

Roy Strowd, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are the primary caregivers for patients with high-grade gliomas, such as astrocytoma or glioblastoma. Caregivers must be able to sit in a chair for 90 minutes and sign consent forms. They can't have used certain brain stimulation therapies recently, have severe hearing loss, weigh over 400 pounds, or be unable to abstain from alcohol or drugs during the study.

Inclusion Criteria

I can sit in a chair for 90 minutes without discomfort.

I am caring for someone over 18 with a high-grade brain tumor.

Trial participant is able to understand and the willingness to sign an IRB-approved informed consent document.

Exclusion Criteria

My weight is at least 400 pounds.

I do not binge drink, as defined by 4 drinks for women and 5 for men in one sitting.

Trial participant has severe hearing impairment defined as word discrimination at <50% with or without the use of hearing aids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cereset Research Office Intervention

Participants undergo standard Cereset Research Office (CRO) in-office treatment for a total of five treatments

10 days

5 visits (in-person)

Ambulatory Therapy

Ambulatory therapy with the Cereset Research Wearable (CRW) available to caregivers during routine radiation therapy with glioma patients

4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Cereset

Trial Overview The Cereset intervention is being tested on caregivers of brain tumor patients to see if it helps manage stress. It's an acoustic therapy previously studied in PTSD and insomnia cases. Participants will undergo quality of life assessments and questionnaires alongside the Cereset sessions.

How Is the Trial Designed?

Group I: Intervention with Ambulatory Therapy Experimental Treatment 4 Interventions

Caregivers of participants with high-grade glioma will undergo standard Cereset Research Office (CRO) in-office treatment for a total of five (5) treatments. Ambulatory therapy with the Cereset Research Wearable (CRW) will be available to caregivers while they are attending routine radiation therapy with glioma patients.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

The Balance Study, involving 78 family caregivers of individuals with dementia, found that mindfulness-based stress reduction (MBSR) significantly improved mental health, reduced stress, and decreased depression compared to community caregiver education and support (CCES).

Both MBSR and CCES were effective in enhancing caregiver mental health, but MBSR showed superior benefits, suggesting it could be a valuable intervention for caregivers dealing with the chronic stress of caring for a family member with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. Whitebird, RR., Kreitzer, M., Crain, AL., et al.[2022]

The integrative stress reduction program (ISRP) significantly decreased caregiver stress and improved sleep quality, as measured by the Relative Stress Scale and Pittsburgh Sleep Quality Index, in a study involving 12 family caregivers over 4 weeks.

Care recipients also showed a reduction in behavioral and psychological symptoms of dementia (BPSD), indicating that the ISRP not only benefits caregivers but also positively impacts the well-being of those they care for.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Integrative Stress Reduction Program for Family Caregivers of Persons With Advanced Dementia: A Pilot Study. Sanprakhon, P., Chaimongkol, N., Hengudomsub, P., et al.[2022]

The comprehensive educational program (CEPRIC) significantly reduced caregiver problems such as disturbed sleep and anxiety, and improved their overall quality of life, as evidenced by a study involving 64 participants (32 caregiver-patient pairs).

Caregiver depression and anxiety scores decreased after the intervention, highlighting CEPRIC's effectiveness in supporting caregivers of individuals with Alzheimer's disease, especially in settings with limited respite care options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a comprehensive educational program on quality of life and emotional issues of dementia patient caregivers. Kuzu, N., Beşer, N., Zencir, M., et al.[2022]

The caregiver stress management intervention, PsychoEducation, Paced Respiration, and Relaxation (PEPRR), significantly reduced caregiver distress over 3 months, indicating its efficacy in supporting caregivers of patients undergoing allogeneic hematopoietic stem cell transplant.

Despite the reduction in caregiver distress, the intervention did not lead to a significant improvement in patient quality of life as measured by the FACT-BMT scale, suggesting that the scale may not capture the psychological benefits of caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized control trial of stress management for caregivers of stem cell transplant patients: Effect on patient quality of life and caregiver distress. Laudenslager, ML., Simoneau, TL., Mikulich-Gilbertson, SK., et al.[2020]

A systematic review of 24 trials (8 open-label and 16 randomized) found that internet-based interventions can effectively reduce caregiver stress, with 6 out of 16 randomized trials showing positive benefits.

While many interventions were effective, there was no consistent pattern in study variables that predicted better outcomes, indicating a need for further research to optimize these interventions for caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing caregiver stress with internet-based interventions: a systematic review of open-label and randomized controlled trials. Hu, C., Kung, S., Rummans, TA., et al.[2022]

Citations

1. school.wakehealth.edu school.wakehealth.edu/departments/neurology/brain-body-research-program/cereset-research/research-to-date

Research to Date - Cereset Research | Wake Forest University ... Cereset Research for Caregivers – This ongoing exploratory study will evaluate the effects of CR in caregivers with symptoms of stress, anxiety, or insomnia.

2. withpower.com withpower.com/trial/phase-glioma-10-2021-75fb6

Cereset for Caregiver Stress · Info for Participants The caregiver stress management intervention, PsychoEducation, Paced Respiration, and Relaxation (PEPRR), significantly reduced caregiver distress over 3 months ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/97/NCT04682197/Prot_SAP_000.pdf

Cereset Research to Reduce Stress in Healthcare Workers ... The primary outcome will be change in Perceived Stress Scale (PSS) a measurement of how different situations affect feelings and perceived ...

4. cereset.com cereset.com/research/

Cereset research A Natural Non-invasive Neuro-technology Improves Sleep and Wellbeing in Randomized, Controlled Clinical Trial · Cereset Research Exposes the Secrets of Traumatic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11888335/

Reducing caregiver stress with internet-based interventions Internet-based interventions were mostly effective in reducing aspects of caregiver stress and improving their well-being.

6. cereset.com cereset.com/brain-health-and-wellness/cereset-description-and-credibility/

Cereset Description and Credibility Cereset creates a brain echo that assists the brain to re-balance itself. The human brain responds powerfully to stimulation, especially sound.