Cereset for Dementia Caregiver Stress

Overseen by Charles Tegeler, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

Must not be taking: Beta blockers, Opiates, Antidepressants, others

Disqualifiers: Hearing impairment, Seizure disorder, Suicidal thoughts, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if Cereset, a sound-based brain therapy, can help caregivers of people with dementia who are stressed or anxious. The therapy aims to improve how their heart responds to stress by balancing brain activity.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants taking medications that affect heart rate variability, such as beta blockers, opiates, benzodiazepines, antipsychotics, antidepressants, sleep medications, stimulants, or thyroid hormones.

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

Cereset is unique because it uses BrainEcho technology, which involves listening to brainwave patterns and providing sound feedback to help the brain relax and reset, unlike traditional stress reduction methods like mindfulness or support groups. ^{1 2 3 4 5}

Research Team

Charles Tegeler, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This study is for caregivers providing at least 10 hours of care weekly to someone with dementia and experiencing stress, anxiety, or insomnia. They must be able to sit for up to 90 minutes, attend three sessions a week over four weeks, and not have plans to travel during the study. Those using certain medications or with conditions like seizure disorders or severe hearing impairment cannot participate.

Inclusion Criteria

I provide 10+ hours of care weekly to someone with dementia.

I feel stressed, anxious, or have trouble sleeping and my scores on related tests are high.

Participants must be willing to provide informed consent

Exclusion Criteria

I cannot sit comfortably for 75 minutes.

Participants with hearing impairment severe enough that they cannot perceive tones through earbuds

Participants anticipating ongoing use of alcohol or recreational drugs

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo 6 Cereset (CR) sessions to evaluate the effect on autonomic cardiovascular regulation and self-reported symptoms

6 weeks

Follow-up

Participants are monitored for changes in heart rate variability, blood pressure, and self-reported symptoms

4-7 weeks

2 visits (in-person)

Treatment Details

Interventions

• Cereset Research (Neuromodulation)

Trial Overview The trial tests Cereset (CR), a neuromodulation method aimed at improving heart rate variability (HRV) in dementia caregivers under stress. It explores whether CR can enhance autonomic cardiovascular regulation through brain lateralization targeting techniques over several sessions.

Participant Groups

Group I: Cereset Research Active Control 1 Intervention

This will be the active intervention arm using 6 Cereset (CR) sessions and participants will continue current care.

Group II: Control Placebo Group 1 Intervention

Participants will have 6 CR sessions of sham control tones and also continue their current care.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Dr. L. Ebony Boulware

Wake Forest University Health Sciences

Chief Medical Officer since 2022

MD from Duke University School of Medicine, MPH from Johns Hopkins Bloomberg School of Public Health

Dr. Julie Ann Freischlag

Wake Forest University Health Sciences

Chief Executive Officer since 2020

BS from University of Illinois, MD from Rush University

Memory Counseling Program general fund

Collaborator

Trials

1

Recruited

20+

Heidi Munger-Clary, MD

Collaborator

Trials

1

Recruited

20+

Hossam Shaltout, PhD

Collaborator

Trials

1

Recruited

20+

Sean Simpson, PhD

Collaborator

Trials

1

Recruited

20+

Christina Hugenschmidt, PhD

Collaborator

Trials

1

Recruited

20+

Mia Yang, MD

Collaborator

Trials

1

Recruited

20+

Findings from Research

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]

Caregivers who reported feeling 'completely overwhelmed' at the start of a comprehensive dementia care program experienced significantly higher levels of distress, depression, and burden compared to those who did not feel overwhelmed, indicating a need for targeted support.

Despite the high levels of distress among overwhelmed caregivers, their feelings did not predict long-term outcomes such as nursing home placement or mortality for the patients they care for, suggesting that caregiver support may be crucial without directly impacting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overwhelmed: a Dementia Caregiver Vital Sign. Reuben, DB., Romero, T., Evertson, LC., et al.[2023]

A study involving 35 family caregivers of individuals with dementia showed that an evidence-based educational class significantly reduced caregiver stress, with 70% of those initially at high risk for stress moving to a low-risk category after the intervention.

The project highlights the importance of providing educational resources and support to caregivers, suggesting that such interventions can improve their health and well-being, and should be integrated into primary care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of a self-care toolkit for caregivers of families with dementia. Smith, CW., Graves, BA.[2023]

Nursing interventions significantly reduced behavioral disturbances in patients with moderate to severe dementia, including aggression and anxiety, over an 18-month period with a sample of 31 subjects.

Caregiver distress also decreased as a result of these interventions, highlighting the potential benefits of education programs that inform caregivers about managing dementia-related challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior disorders and subjective burden among caregivers of demented patients. Eloah, LFC., Bertolucci, PHF., Minett, TSC.[2022]

The Berlin Inventory of Caregiver Stress-Dementia (BICS-D) is a reliable and valid tool for assessing the multidimensional stress experienced by caregivers of individuals with dementia, based on a study involving 594 caregivers.

The inventory can differentiate the burden experienced by various caregiver subgroups (like partners and children) and is sensitive to changes in caregiver stress, making it useful for evaluating interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Berlin Inventory of Caregiver Stress-Dementia (BICS-D). Schlomann, A., Schacke, C., Leipold, B., et al.[2021]

References

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

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

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

Overwhelmed: a Dementia Caregiver Vital Sign. [2023]

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

Implementation and evaluation of a self-care toolkit for caregivers of families with dementia. [2023]

4. Brazil pubmed.ncbi.nlm.nih.gov

Behavior disorders and subjective burden among caregivers of demented patients. [2022]

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

Berlin Inventory of Caregiver Stress-Dementia (BICS-D). [2021]