High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM) to relieve insomnia: A randomized, placebo-controlled clinical trial
This single site, randomized, placebo-controlled research trial will endeavor to determine whether the addition of HIRREM to usual care will improve insomnia symptoms based on changes in the ISI at two months following completion of the intervention, compared to placebo plus usual care. Up to 100 participants, age 18 or over, will be recruited. This study is designed to confirm results of prior work using a placebo control, a larger study sample, with a standard number of HIRREM sessions, while extending the primary outcome measure to two months following completion of the intervention, and the total follow-up period to four months following completion of HIRREM or placebo. Enrollment is ongoing (click image below for more information).
Functional and physiological effects of high-resolution,
relational, resonance-based, electroencephalic mirroring (HIRREM) for
neurological, cardiovascular and psychophysiological disorders
Also known as the Developmental Study, the purpose of this exploratory study is to ascertain the functional and physiological effects of HIRREM as supplemental care in populations and individuals age 11 and older, with a variety of neurological, cardiovascular, and psychophysiological diseases. The scope of the conditions to be investigated is broad since it is the intention of this proposal to allow the recruitment of a wide variety of patients at the discretion of the investigators. One goal is to allow investigators to identify patient cohorts which would be desirable for further study, some of which may not be intuitively obvious, using such data as the basis for pursuit of additional disease-specific research projects, or funding opportunities. Such data, prospectively gathered in a carefully monitored clinical environment through this proposal, can serve as a foundation for the pursuit of future randomized controlled pilot studies, and eventually larger randomized controlled clinical trials.
This project has provided the data for analysis of case series of participants with symptoms of post-traumatic stress disorder (PTSD), traumatic brain injury (TBI), hot flashes, and postural orthostatic tachycardia syndrome (POTS), and others. It has also allowed an opportunity for analysis of brain patterns before and after HIRREM, correlations with downstream autonomic cardiovascular control, as measured with heart rate variability (HRV) and barorelex sensitivity (BRS), and correlations at baseline between brain pattern and HRV/BRS. This has resulted in the submission of a series of abstracts, with presentation of posters and oral platform presentations at national meetings. The data have also formed the basis for several publications (see Presentations and Publications), grant applications, and plans for focused, controlled research projects.
HIRREM for mitigation of symptoms of traumatic stress in military personnel
A single site, open label feasibility trial is underway to evaluate the use of HIRREM as an adjunct for 10 military service members with a diagnosis of PTSD or with symptoms of traumatic stress, with or without mild TBI, who also meet protocol exclusion criteria for current medications. The primary outcome is differential change on symptoms of traumatic stress (PCL-M). Secondary outcome measures include a variety of additional symptom inventories for sleep (ISI), depressive mood (CES-D), anxiety (GAD-7), autonomic symptoms (Compass 31), and post-concussion symptoms (RPQ), along with functional measures of grip strength, and strop stick reaction time. Secondary outcome measures for this projects also include pre- and post-intervention blood pressure and heart rate recordings to evaluate autonomic cardiovascular control, brain MRI scans for network connectivity, and a panel of blood and saliva biomarkers for stress and inflammation. Funding for this project was made possible through the Joint Capability Technology Demonstration Program within the Office of the Under Secretary of Defense (Acquisition, Technology, and Logistics) via a contract with the U.S. Special Operations Command.
Pilot study of HIRREM in elderly participants with or without insomnia
This single site, open label, pilot research study will evaluate the effects of HIRREM on sleep in the elderly (n=5 with insomnia, n=5 without insomnia). The primary outcome will be differential changes in symptoms of insomnia (ISI), with a host of secondary outcome measures. Secondary outcomes will include pre- and post-HIRREM MRI brain scans to evaluate brain network connectivity, a panel of blood and saliva biomarkers for stress and inflammation, a variety of other symptom inventories, functional measures of grip strength and drop-stick reaction time, and performance on a cognitive battery. This study is funded by research grants to Dr. Paul Laurienti from the Translational Science Institute of Wake Forest University, and the Center for Integrative Medicine of Wake Forest Baptist Health. This is a collaborative activity for which the Department of Neurology will provide the HIRREM intervention, and assist with data collection and analysis.