Clinical trial NCT05209438: Cereset Research Exploratory Study for Dementia Caregivers
Official title: Cereset Research for Dementia Caregivers: A Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia Caregivers
Keywords: caregiver
caregiving
stress
anxiety
insomnia
neurotechnology
autonomic dysregulation
hyperarousal
brain electrical activity
allostasis
Alzheimer's
dementia
neuromodulation
acoustic stimulation
heart rate variability
High-resolution relational resonance-based electroencephalic mirroring HIRREM
Cereset Research
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Memory Counseling Program general fund
name: Heidi Munger-Clary, MD
name: Hossam Shaltout, PhD
name: Sean Simpson, PhD
name: Christina Hugenschmidt, PhD
name: Mia Yang, MD
First posted: 2022-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prior to the start of the randomized Phase II for the trial, a limited intervention-only pilot will be carried out with up to 5 participants (Phase I). The purpose of this is to confirm feasibility of cohort and identify challenges, intervention, and outcome assessment procedures to ensure they are optimized by the start of the randomized phase, and allow additional time to work towards any obstacles that arise with the placebo.

Phase II will be a single-blind, randomized, pilot clinical trial that aims to enroll 20 participants who will be randomized to receive 6 sessions of CR intervention linked to brainwaves (INT) (n=10) or 6 sessions of sham control tones not linked to brainwaves (CON) (n=10). In this study, the tones not linked to brainwaves will be used as the control.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Caregivers of a person living with dementia (PLWD) experience high levels of prolonged stress that can lead to chronic problems with health, including increased risk of cardiovascular disease that is linked to autonomic dysregulation. Heart rate variability (HRV), measures of autonomic cardiovascular regulation, is decreased (worse) in caregivers of a person living with dementia. Autonomic function is linked to lateralization in the brain, and emerging neuromodulation methods that target lateralized signals in the brain, like Cereset (CR), may be able to improve heart rate variability. Therefore, this pilot study aims to test whether CR can improve HRV in caregivers of a person living with dementia experiencing stress, anxiety, or insomnia, as well as improve self-report measures of stress, sleep and caregiver burden.

Detailed description: Phase I: Intervention only pre-piloting: up to 5 adults; mirroring Phase II characteristics described below

Phase II: 20 dementia caregivers experiencing symptoms of stress, anxiety or insomnia. Primary aims are to:

1) Evaluate the effect of CR to improve autonomic cardiovascular regulation measured as heart rate variability (HRV) and baroreflex sensitivity (BRS). Impact will be assessed based on changes in standard measures of HRV and BRS such as SDNN, rMSSD, HF Alpha, and Sequence ALL. This will also provide blood pressure values evaluated by an automated oscillometric blood pressure device.

2) Assess the effect of CR on self-reported symptom inventories of stress, anxiety, insomnia, and caregiver burden and distress.

1. Insomnia as assessed by the Insomnia Severity Index (ISI).
2. Behavioral outcomes such as depression (as assessed by the Center for Epidemiological Studies-Depression Scale, CES-D), anxiety (as evaluated by the GAD-7), traumatic stress (as assessed by the PCL-C), and stress (as assessed by the Perceived Stress Scale, PSS).
3. Overall quality of life as evaluated using the QOLS measure.
4. Caregiver burden and distress measured with the Zarit Caregiver Burden scale and the Neuropsychiatric Inventory Questionnaire (NPI-Q).
5. Brief (4-item) caregiver self-efficacy scale.

Eligibility criteria: Inclusion Criteria:

* 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)
* participants must be willing to provide informed consent
* participants have no planned travel during the study period
* participants must be able to comply with basic instructions
* participants must be able to sit comfortably for up to 90 minutes, and attend up to three 60-minute intervention sessions each week during the 4-week intervention period
* participants must self report experiencing symptoms of stress, anxiety, or insomnia and meet threshold scores on one or more self-report inventories of these symptoms (Insomnia Severity Index (ISI, ≥ 8), the Perceived Stress Index (PSS, ≥ 14), or the Generalized Anxiety Disorder 7-item (GAD-7, ≥ 5) scale)

Exclusion criteria:

* participants providing less than 10 hours a week of care to a person with dementia
* participants who are unable or unwilling to attend intervention sessions during the planned study period
* participants who are unable or unwilling to provide consent
* participants who are unable to sit comfortably for up to 75 minutes
* participants who are not exhibiting symptoms of stress, anxiety or insomnia
* participants with hearing impairment severe enough that they cannot perceive tones through ear buds
* participants anticipating ongoing use of alcohol or recreational drugs
* participants with known seizure disorder, or suicidal thoughts within the last 3 months
* 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
* participants weighing more than 400 pounds (the weight limit of the chair used during intervention)
* participants currently enrolled in another intervention study
* prior use of neuromodulation, neurostimulation, deep brain stimulation, neurofeedback, biofeedback, alpha stim, Eye Movement Desensitization and Reprocessing (EMDR),or electroconvulsive therapy within the last month
* participants taking Medications that may affect the assessment of heart rate variability (beta blockers. Ongoing need for treatment with opiate, benzodiazepine, or anti-psychotic medications, anti-depressant medications (SSRI, or SNRI's), sleep medications such as zolpidem or eszopiclone, stimulants such as Adderall, Provigil, or Ritalin, or thyroid hormone)

Primary outcomes:
measure: Change in Blood Pressure Measurements
timeFrame: Baseline; V2 (0-14 days after intervention completion; V3 (4-7 weeks following completion of the intervention)
measure: Change in Heart Rate (HR)
timeFrame: Baseline; V2 (0-14 days after intervention completion; V3 (4-7 weeks following completion of the intervention)
measure: Change in Heart Rate Variability (HRV)
timeFrame: Baseline; V2 (0-14 days after intervention completion; V3 (4-7 weeks following completion of the intervention)
measure: Change in Baroreflex Sensitivity
timeFrame: Baseline; V2 (0-14 days after intervention completion; V3 (4-7 weeks following completion of the intervention)
measure: Blood Pressure Variability
timeFrame: V3 (4-7 weeks following completion of the intervention)
Secondary outcomes:
measure: Severity of Insomnia (ISI)
timeFrame: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)
measure: Generalized Anxiety Disorder-7 (GAD-7) scores
timeFrame: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)
measure: PTSD Checklist for civilians (PCL-C)
timeFrame: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)
measure: Perceived Stress Scale (PSS)
timeFrame: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)
measure: Quality of Life Scale (QOLS)
timeFrame: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)
measure: Caregiver Burden (Zarit)
timeFrame: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)
measure: Caregiver Distress (NPI-Q)
timeFrame: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)
Other outcomes:
measure: Changes in Chronic Pain (MPQ)
timeFrame: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)
measure: Changes in Chronic Pain (PROMIS)
timeFrame: Baseline, V2 (0-14 days after intervention completion, and V3 (4-7 weeks following completion of the intervention)
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Charles Tegeler, MD
role: PRINCIPAL_INVESTIGATOR
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