Randomized, controlled study of long-term maintenance Cereset Research after an initial4-session intervention bolus versus usual care control following an initial 4-sessionintervention bolus.
This randomized, controlled study will evaluate the effects of long-term Cereset Research
maintenance intervention in healthcare workers with symptoms of stress in the post era of
COVID-19. Healthcare workers of all types have been impacted personally, professionally,
and financially by the pandemic and its aftermath, resulting in higher levels of stress
and anxiety. Additional, brief, noninvasive, non-drug strategies are needed to help
mitigate the effects of the acute trauma associated with the pandemic. The primary
outcome will be change in Perceived Stress Scale (PSS) a measurement of how different
situations affect feelings and perceived stress in the Intervention group compared to the
Control Group. Data will also be collected on a variety of additional relevant symptoms
including insomnia, anxiety and autonomic cardiovascular regulation, for which benefits
have been shown in prior studies using High-resolution, relational, resonance-based,
electroencephalic mirroring (HIRREM). Data collected will assess the long-term effects of
a low dose Cereset Research (CR) approach (only 4 sessions) and the importance of
long-term maintenance intervention versus control. The Intervention Group will then
receive 1 session every 6 weeks beginning 6 weeks after the 4 session bolus is completed.
The Control Group continues current care with no additional CR sessions. A successful
outcome of reduced stress at 1 year in the Intervention Group vs. Control Group would
suggest benefit for long-term maintenance intervention sessions. The effect of this
approach on autonomic function and other self-reported symptoms will also be explored.
This information will be useful for determining intervention schedules for direct
clinical implementation of the intervention. The proposed study might also help to
identify characteristics of individuals who may experience differential effects/benefits
from application of CR and determine if intermittent "tune-up" sessions may prolong
symptom improvement.
Device: Cereset Research
The upgraded platform for medical research using the HIRREM technology has been rebranded
as Cereset Research® (CR). This system uses the same core technology and algorithms to
echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also
includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and
the use of standard protocols (with flexibility regarding the length and sequencing of
the standard protocols), all done with eyes closed. Four sensors are applied to the scalp
at a time. However, only two sensors are actively echoing feedback. The software
automatically switches from one sensor pair to the other when needed. This reduces the
number of sensor placement changes needed, resulting in shorter session time and fewer
interruptions.
Inclusion Criteria:
- Employed healthcare workers aged 18 years and older.
- Have availability and interest in participating in a 1 year study.
- Ability to comply with basic instructions and be able to sit still, comfortably
during sessions.
- Experiencing symptoms of stress meeting threshold score on the Perceived Stress
Scale (PSS ≥ 14).
Exclusion Criteria:
- No internet access, as some visits collected electronically
- Unable, unwilling, or incompetent to provide informed consent.
- Physically unable to come to the study visits, or to sit still, comfortably in a
chair for up to 1 hour.
- Severe hearing impairment (because the subject will be using ear buds during CR).
- Weight is over the chair limit (400 pounds).
- Currently enrolled in another active intervention research study.
- Prior use of: HIRREM, HIRREM-SOP, Brainwave Optimization (BWO), Cereset, Cereset
Research, Cereset Home, or a wearable configuration of the same (B2, or B2v2).
- Prior use of the following modalities within one month before enrollment:
electroconvulsive therapy (ECT), prior use of transcranial magnetic stimulation
(TMS), transcranial direct current stimulation (TDCS), alpha stimulation, eye
movement desensitization and reprocessing (EMDR), brain spotting, neurofeedback,
biofeedback, or deep brain stimulation (DBS).
- Known seizure disorder.
- Thoughts of active suicide within the last 3 months.
- Current medical student.
Atrium Wake Forest Baptist Health
Winston-Salem 4499612, North Carolina 4482348, United States
Charles H Tegeler, MD, Principal Investigator
Wake Forest University Health Sciences