With an exploding behavioral and mental health crisis in the United States (and increasingly worldwide), what if there was a way to systematically tune-up, improve, or even optimize brain health without pharmaceutical products via an advanced neurorestorative technology?  An approach that could not only transform patients’ lives but also teams, companies, and organizations? A well-known foundational technology called Repetitive Transcranial Magnetic Stimulation (rTMS), a Food and Drug Administration (FDA)-approved, non-invasive, non-pharmaceutical approach for treating adults with major depression, may become even more tailored to the particular patient with the novel personalized Transcranial Magnetic Simulation or “PrTMS®,” a CrossTx partner and cutting-edge investigational digital health therapy soon to be a focal point of major clinical trials including one at West Virginia University. A planned study to commence this summer will use this digital health platform, based on neural alpha wave dynamics targeting TMS intervention factoring in location and frequency of TMS location to take on mission-critical behavioral and mental health indications. Already used as an off-label treatment non-therapeutically across the United States, this forthcoming clinical trial assesses the ability of PrTMS to enhance critically important targets of cognitive performance and sleep quality from baseline metrics.

Is there a failed revolution in mental health?

Are the current treatment regimens for behavioral and mental health treatment working well?  The pandemic has only intensified what can be described as an epidemic of mental health crises across America. Some reports reveal that the number of Americans experiencing anxiety and depression is up by 42, which cost America big time.

By 2019, spending on mental health services was already at $225 billion. These costs were segmented by up to $44 billion alone in losses to workplace productivity according to a recent Tufts Medical Center report. Comprising a large percentage of the $225 billion is therapy, prescription medications, and stays in psychiatric or substance abuse rehabilitation centers. But many mental health professionals acknowledge we may be approaching the limits of existing medications, especially pharmaceuticals such as SSRs. For example, the SSRI market is expected to reach over $18 billion by 2027, yet the performance of these drugs is under ever more scrutiny.

Enter a novel approach invented by a brilliant ex-Naval office engineer turned board-certified radiation oncologist. 

The Genesis of the Investigational Digital Health Product

PeakLogic is the brainchild of Dr. Kevin Murphy, an impressive, committed physician who sought to transform behavioral and mental health care as we know it. A US Navy veteran who served the U.S. during Operations Desert Shield/Desert Storm as an engineering officer aboard the USS Ranger, the board-certified radiation oncologist originally specialized in treating tumors of the central nervous system, brain, and spinal cord before going on to found multiple companies while authoring numerous book chapter, abstracts, and peer-reviewed papers.

Several years ago, Murphy founded San Diego-based digital health company PeakLogic. Murphy discovered the potential of the emerging field of repetitive transcranial magnetic stimulation (rTMS), which led to improvements and refinements and his novel PrTMS. Along with a clinic he founded called MindSet (also in San Diego), Murphy has developed a stellar reputation working with Navy SEAL veterans and pro athletes who have a significant interest in maintaining high-level performance. 

What is Investigational Digital Therapy?

The investigational product, PrTMS, is already in use as a non-therapeutic treatment by soldiers, professional athletes, and other people involved with high performance-driven roles. Neural alpha wave dynamics have been harnessed to not only target its TMS intervention via the investigational product but also to enhance and extend existing behavioral and mental health impacts.

As published in the public U.S. national clinical trials registry, this digital health solution is successful: “researchers should be able to observe specific changes, e.g., more consistent fundamental frequency and in increased alpha wave coherence across multiple brain sites, as PrTMS intervention progresses.”

Importantly, in the phenomena called alpha wave coherence, the presence of alpha oscillations across sizable areas of the temporal cortex suggests alpha oscillations could be supportive of the symphonizing activity between cortical regions. Moreover, alpha wave coherence could be associated with superior sleep patterns, for example, not to mention cognition and emotional responsiveness.

Dr. Murphy has been developing the investigational health solution for a number of years now. For the last few years, he has partnered with Bozeman-based CrossTx, a HIPAA-complaint software company supporting alternative payment models for Medicare and Medicaid, closed-loop referral management, and behavioral health networks for organizations, such as unified school districts, across the country. With deep expertise In compliance, rule-driven workflow automation, and advanced health-centric algorithms, including artificial intelligence, CrossTx was founded by software developers involved with the founding of RightNow Technologies, acquired by Oracle for $1.5 billion in 2011. CrossTx founder Chad Nybo serves PeakLogic as CTO.

How does this digital therapy work?

PrTMS can potentially serve as a transformative digital mental and behavioral health solution by a steady nudging of neural alpha wave responses toward a common fundamental frequency (10 to 12HZ) across all regions of the brain. 

While such frequencies may vary over time—similar to all natural systems—larger variations are associated with behavioral challenges from anxiety and PTSD to sleep problems and other comparable conditions. But PrTMS may help bring coherence to neural activity across the brain, leading to a more natural and efficient brain activity state. What Dr. Murphy has discovered, at least working in the real world in the non-medical world of performance optimization, is that PrTMS triggers downstream impacts from the alleviation of symptoms relative to brain-related disease/injury to improved cognitive function.

Investigational Hypothesis

Study teams at West Virginia University and other major academic medical centers embracing this novel investigational digital health regimen hypothesize that changes in neural activity (as detected via qEEG) could very well result in numerous positive behavioral and perceptual responses even in purported health populations such as improved mood state, less anxiety, and the like.

The Study

Now the PeakLogic PrTMS digital health investigational product has become the subject of a serious clinical study sponsored by West Virginia University. Commencing by July 2022, the randomized, parallel assignment-controlled trial including 72 participants will randomly enroll participants in an active or sham intervention group.  

Each participant in the PrTMS stud will complete 30 PrTMS or sham sessions as part of a six-week study regimen while participants will wear a lab-provided sleep tracking ring produced by OUra. Regardless of the cohort, each study participant will complete a daily and weekly survey as well as an assessment, including a qEEG and cognitive assessments. The study team plans to ask participants to engage in surveys at intake, study midpoint, and study exit.

The study protocol includes an active comparator arm (PrTMS) and sham comparator arm (Sham) with a range of primary endpoints, including:

Study Endpoints

Study Endpoint	Description
Change in Nocturnal Heart Rate as measured by OURA  Ring [ Time Frame: Daily from baseline through study completion at 6 weeks]	Heart rate (beats per minute) will be quantified throughout the night via the OURA ring.
Change in Nocturnal Heart Rate Variability as measured by OURA Ring [ Time Frame: Daily from baseline through study completion at 6 weeks]	Heart rate variability (as measured by variance in time between heart beats) will be quantified throughout the night via the OURA ring.
Change in Nocturnal Heart Rate Variability as measured by OURA Ring [ Time Frame: Daily from baseline through study completion at 6 weeks]	Heart rate variability (as measured by variance in time between heart beats) will be quantified throughout the night via the OURA ring.
Change in Sleep Latency as measured by OURA Ring [ Time Frame: Daily from baseline through study completion at 6 weeks]	Sleep onset latency will be quantified throughout the night via the OURA ring.
Change in Sleep Score as measured by OURA Ring [ Time Frame: Daily from baseline through study completion at 6 weeks]	Total sleep score will be quantified throughout the night via the OURA ring.
Change in Total Sleep Time as measured by OURA Ring [ Time Frame: Daily from baseline through study completion at 6 weeks]	Time of sleep will be quantified throughout the night via the OURA ring.
Change in Sleep Efficiency as measured by OURA Ring [ Time Frame: Daily from baseline through study completion at 6 weeks]	Sleep efficiency will be quantified throughout the night via the OURA ring.
Change in Sleep Quality as measured via Questionnaire [ Time Frame: Daily from baseline through study completion at 6 weeks]	A custom daily morning questionnaire will be used to record how a participant feels in regard to sleep restoration, recovery, and overall stress. This will be taken on the participants’ smartphones within an hour of waking. Scores range from 3-10 with higher scores indicating poor sleep.
Change in Recovery as measured via Questionnaire [ Time Frame: Daily from baseline through study completion at 6 weeks]	A custom daily morning questionnaire will be used to record how a participant feels in regard to sleep restoration, recovery, and overall stress. This will be taken on the participants’ smartphones within an hour of waking. Scores range from 4-24 with higher scores indicating better recovery.
Change in Stress as measured via Questionnaire [ Time Frame: Daily from baseline through study completion at 6 weeks]	A custom daily morning questionnaire will be used to record how a participant feels in regard to sleep restoration, recovery, and overall stress. This will be taken on the participants’ smartphones within an hour of waking. Scores range from 4-24 with higher scores indicating more stress.
Change in Sustained Attention and Reaction Time [ Time Frame: Daily from baseline through study completion at 6 weeks]	The Psychomotor Vigilance Task will be administered each morning within an hour of waking. This task will be completed on the participants’ smartphone. Performance is calculated as 100% minus the number of lapses or false starts.

About West Virginia University

With an over $611 million endowment, West Virginia University is a public land-grant research university based in Morgantown, West Virginia. With enrollment across all its three campuses at nearly 30,000, the Morgantown campus offers over 350 bachelor’s, master’s, doctoral, and professional degree programs throughout 14 colleges and schools.

West Virginia University is classified among “R1: Doctoral Universities” as very high research activity and according to the National Science Foundation, this university spent $185.1 million on research and development by 2018.  The academic research center is affiliated with the Rockefeller Neurosciences Institute dedicated to the study of Alzheimer’s and other diseases impacting the brain.

Noteworthy, West Virginia University serves as a leader in biometric technology research as well as the Federal Bureau of Investigation’s lead partner in biometrics research.

About PeakLogic 

Founded in 2017 by Dr. Kevin Murphy, PeakLogic’s PrTMS solution is now the subject of FDA-compliant, randomized controlled trials. The digital health solution company aims to support multiple major academic medical center-led randomized controlled trials supporting investigations into PrTMS as a digital therapy for major mental health and neurocognitive disorders, including human performance. The company is also working on a pipeline of other investigational products that it hopes to subject to randomized controlled studies with an aim of markedly improving TMS therapy more broadly.

The company has been approached by major corporations, professional sports associations/leagues, governmental, and Department of Defense agencies for peak performance initiatives. A robust international network of physicians, mental and behavioral health professionals, and people dedicated to high performance continues to support PeakLogic collaborations. See founder Kevin Murphy’s profile.