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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
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)
Awards & highlights
Study Summary
This trial will test whether a brain-targeted intervention called Cereset can help improve heart rate variability in caregivers of people with dementia who are experiencing stress, anxiety, or insomnia, as well as improve self-report measures of stress, sleep and caregiver burden.
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.Check my eligibility
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.See study design
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 belowSelect...
I provide 10+ hours of care weekly to someone with dementia.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood Pressure Variability
Change in Baroreflex Sensitivity
Change in Blood Pressure Measurements
+2 moreSecondary outcome measures
Caregiver Burden (Zarit)
Caregiver Distress (NPI-Q)
Center for Epidemiologic Studies Depression Scale (CES-D)
+5 moreOther outcome measures
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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,247 Total Patients Enrolled
Memory Counseling Program general fundUNKNOWN
Heidi Munger-Clary, MDUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I provide 10+ hours of care weekly to someone with dementia.I cannot sit comfortably for 75 minutes.I feel stressed, anxious, or have trouble sleeping and my scores on related tests are high.I am not on medications that could affect heart rate measurements.I haven't used any brain stimulation or feedback therapies in the last month.I do not have symptoms of stress, anxiety, or insomnia.I have not felt at risk of suicide in the last 3 months.I cannot or do not want to attend the study sessions.I can sit for 90 minutes and attend three sessions weekly for a month.I have had seizures or suicidal thoughts in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Cereset Research
- Group 2: Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary goals that this clinical trial seeks to accomplish?
"The primary outcome of this trial, measured over the course of Baseline; V2 (0-14 days after intervention completion); and V3 (4-7 weeks following completion) is to gauge any changes in Blood Pressure Measurements. Secondary outcomes encompass Center for Epidemiologic Studies Depression Scale (CES-D), Perceived Stress Scale (PSS), and Caregiver Distress (NPI-Q). CES-D ranges from 0-60 with higher scores suggesting more depressive symptoms, PSS uses a 0-40 scale where lower values indicate less stress levels, and NPI-Q severity score can range between 0"
Answered by AI
Is enrollment still available in this research endeavor?
"Reportedly, this clinical trial is presently recognizing applicants. It was initially announced on June 16th 2022 and has recently been revised on September 27th of the same year."
Answered by AI
What is the current enrollment figure for this trial?
"That is correct. The clinicaltrials.gov website indicates that this medical trial, originally posted on June 16th 2022, is currently enrolling patients. 20 individuals are required from a single location."
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