N.C. – May 15, 2018 – Use of a noninvasive, brainwave-mirroring
technology significantly improved heart rate variability (HRV) for a large
heterogeneous cohort, in a pilot study conducted at Wake Forest Baptist Medical
Center. The study was published in the April 18 online edition of Frontiers in
“Negative health outcomes due to the effects of chronic
stress are rampant in today’s society,” said the study’s principal
investigator, Charles H. Tegeler, M.D., professor of neurology at Wake Forest
School of Medicine, a part of Wake Forest Baptist.
“The autonomic nervous system drives the body’s response
to traumatic stress, such as the sympathetic fight or flight response. The brain manages the autonomic nervous
system. The brain has plasticity, can change its pattern of function based on
need. Repetitive or severe trauma may
cause stress responses to get stuck or persist beyond the period of acute need. Symptoms such as insomnia or diseases such as
hypertension may result.”
Heart rate variability is an indicator of the dynamic
adaptability of the autonomic nervous system.
Chronic stress is associated with low HRV, which is in turn a risk
factor for conditions such as heart disease, diabetes and death. Few therapies have targeted the brain to
improve HRV, Tegeler said.
High-resolution, relational, resonance-based, electroencephalic
mirroring (HIRREM) – is a noninvasive, closed-loop, acoustic stimulation
approach. Computer software algorithms
translate specific brain frequencies into audible tones in real time, which are
then reflected back via ear buds.
“The recipient’s brain can listen to itself through an
acoustic mirror,” Tegeler said. “Likely
through resonance between brain frequencies and the acoustic stimulation, the
brain is supported to self-adjust towards improved balance and reduced
hyperarousal. This allows
self-optimization of autonomic stress response patterns that have become
rewired or stuck by repetitive traumatic events, whether physical or
non-physical, with no conscious, cognitive activity required.
This single-site study enrolled 220 participants with an
array of neurological, cardiovascular and psychophysiological conditions, into
a single-arm study exploring clinical effects associated with use of HIRREM. Of
the enrolled participants, 202 completed the study, and 160 had recordings of
blood pressure and pulse that could be analyzed for HRV.
“We observed significantly increased measures of HRV,
suggesting greater dynamic adaptability, along with significant improvement in
blood pressure, and reduced symptoms of insomnia and depression,” Tegeler said.
“There was also correlation between brain pattern and a measure of HRV.”
Limitations of the study include the absence of a control
group. It also was an open-label project, meaning that both researchers and
participants knew what intervention was received. Future
studies evaluating this technology will incorporate a new generation of hardware
and software, and be done using randomized clinical trial designs that include
a representative comparison group.
HIRREM is a registered by Brain State Technologies, based
in Scottsdale, Arizona, and has been licensed to Wake Forest Baptist for
collaborative research since 2011.
The study was supported by a grant from The Susanne
Marcus Collins Foundation, Inc. to the Department of Neurology at Wake Forest
Baptist. More information about this research program can be found at
Co-authors include: Hossam A. Shaltout, Ph.D., Catherine
L. Tegeler, B.S., Joshua R. Hirsch, B.S.E., and Sean L. Simpson, Ph.D., of Wake
Forest Baptist; Sung W. Lee, M.D., M.Sc., of the University of Arizona, and Lee
Gerdes, of Brain State Technologies of Scottsdale, Arizona.