What is the mechanism of action of this treatment?

Common treatments for dementia caregivers include stress management techniques, cognitive-behavioral therapy (CBT), and neuromodulation methods like Cereset (CR). Cereset (CR) works by targeting lateralized brain signals to improve autonomic function and HRV, which are often impaired in caregivers due to chronic stress. Improved HRV indicates better autonomic regulation, which can reduce the risk of cardiovascular issues and improve overall health. This is crucial for dementia caregivers as it helps manage the high levels of stress, anxiety, and insomnia they often experience, thereby enhancing their ability to provide care and maintain their own well-being.

What side effects are associated with this type of intervention?

Neuromodulation treatments, such as transcranial magnetic stimulation (TMS) and electrical nerve stimulation, which are similar to Cereset (CR), generally have mild side effects. Common side effects include headache, scalp discomfort at the stimulation site, and tingling or twitching of facial muscles. In rare cases, more serious side effects like seizures can occur, particularly in individuals with a history of epilepsy. These treatments aim to improve autonomic function and HRV, potentially reducing stress, anxiety, and insomnia in dementia caregivers.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for dementia caregivers that focus on neuromodulation targeting lateralized brain signals to improve autonomic function and heart rate variability (HRV). However, treatments for dementia-related symptoms often include cholinesterase inhibitors like donepezil and memantine, which are approved for Alzheimer's disease. These medications aim to manage cognitive and behavioral symptoms but do not specifically address caregiver stress or autonomic function. Emerging therapies like Cereset (CR) are being studied for their potential to improve HRV and reduce stress in caregivers through neuromodulation, but they have not yet received FDA approval.

What other types of research exist?

Promising alternatives to Cereset (CR) for dementia caregivers include: 1) Transcutaneous Electrical Nerve Stimulation (TENS), which has shown benefits in improving rest-activity rhythms in Alzheimer's patients; 2) Cognitive Behavioral Therapy for Insomnia (CBT-I), which is effective in reducing stress and improving sleep quality; 3) Pharmacological options like melatonin and suvorexant, which can improve sleep and reduce stress; and 4) Telemedicine interventions for remote monitoring and support, which have shown benefits in managing chronic conditions and reducing caregiver burden.

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Neuromodulation

Cereset for Dementia Caregiver Stress

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

Participants must provide at least 10 hours of care a week to a person with a diagnosis of dementia (including Alzheimer's disease (early onset or late onset), frontotemporal dementia, Lewy body dementia, Parkinsonian dementia, and mixed dementias)

Be older than 18 years old

Must not have

Participants who are unable to sit comfortably for up to 75 minutes

Participants who respond positively to a question about risk for suicide within the last 3 months will be excluded and receive a behavioral health resource list

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, v2 (0-14 days after intervention completion, and v3 (4-7 weeks following completion of the intervention)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly mentioned in the provided information but could include discomfort from sitting long periods during sessions and possible unknown reactions to the neuromodulation technique.

Eligibility Criteria

Inclusion Criteria

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

Select...

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

Exclusion Criteria

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

Select...

I cannot sit comfortably for 75 minutes.

Select...

I have not felt at risk of suicide in the last 3 months.

Select...

I cannot or do not want to attend the study sessions.

Select...

I have had seizures or suicidal thoughts in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, v2 (0-14 days after intervention completion, and v3 (4-7 weeks following completion of the intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, v2 (0-14 days after intervention completion, and v3 (4-7 weeks following completion of the intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, v2 (0-14 days after intervention completion, and v3 (4-7 weeks following completion of the intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood Pressure Variability

Change in Baroreflex Sensitivity

Change in Blood Pressure Measurements

+2 more

Secondary study objectives

Caregiver Burden (Zarit)

Caregiver Distress (NPI-Q)

Center for Epidemiologic Studies Depression Scale (CES-D)

+5 more

Other study objectives

Changes in Chronic Pain (MPQ)

Changes in Chronic Pain (PROMIS)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Cereset ResearchActive Control1 Intervention

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

Group II: ControlPlacebo Group1 Intervention

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

0 / 5Eligibility 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 dementia caregivers include stress management techniques, cognitive-behavioral therapy (CBT), and neuromodulation methods like Cereset (CR). Cereset (CR) works by targeting lateralized brain signals to improve autonomic function and HRV, which are often impaired in caregivers due to chronic stress. Improved HRV indicates better autonomic regulation, which can reduce the risk of cardiovascular issues and improve overall health. This is crucial for dementia caregivers as it helps manage the high levels of stress, anxiety, and insomnia they often experience, thereby enhancing their ability to provide care and maintain their own well-being.

Different durations of cognitive stimulation therapy for Alzheimer's disease: a systematic review and meta-analysis.Adrenergic Drugs Blockers or Enhancers for Cognitive Decline ? What to Choose for Alzheimer's Disease Patients?[Effects of a neuropsychology program based on mindfulness on Alzheimer's disease: randomized double-blind clinical study].