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

Trial Summary

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 data supports the effectiveness of the treatment Cereset for caregiver stress?

The research suggests that reducing caregiver stress can improve their quality of life and the care they provide, which is relevant to Cereset's goal of reducing caregiver stress. While specific data on Cereset is not provided, interventions that manage caregiver stress have shown benefits in similar contexts. ^{1 2 3 4 5}

How is the Cereset treatment different from other treatments for caregiver stress?

Cereset is unique because it uses a non-invasive, brainwave-based approach to help caregivers manage stress, unlike other treatments that may focus on education or mindfulness. This method aims to balance brain activity, potentially offering a novel way to reduce stress without medication. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial tests if Cereset, a sound-based treatment, can help stressed caregivers of high-grade glioma patients by using real-time sound feedback to balance brain activity.

Research Team

Roy Strowd, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

References

1. England 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. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Reducing caregiver stress with internet-based interventions: a systematic review of open-label and randomized controlled trials. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Putting Evidence into Practice: nursing assessment and interventions to reduce family caregiver strain and burden. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Family Caregiver Strain and Burden: A Systematic Review of Evidence-Based Interventions When Caring for Patients With Cancer. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

End-of-life caregiving: what helps family caregivers cope? [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of a comprehensive educational program on quality of life and emotional issues of dementia patient caregivers. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

An Integrative Stress Reduction Program for Family Caregivers of Persons With Advanced Dementia: A Pilot Study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Respite Care via Short-Stay Services to Support Sleep in Family Caregivers. [2020]

9. France pubmed.ncbi.nlm.nih.gov

["Bull'therapy", a decompression chamber for carers]. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for family caregivers: a randomized controlled trial. [2022]