Cereset® Announces Mild-Traumatic Brain Injury Focused Clinical Trial Progress

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Results to date demonstrate that Cereset’s technology may help U.S. military personnel suffering from concussion

Cereset Research Process

Cereset® Research Process

Today Cereset®, the only proven non-invasive technology that helps your brain relax and reset itself, announced the midway point of its randomized research trial for individuals with persisting symptoms following mild-Traumatic Brain Injury (mTBI). The objective of the study is to measure the efficacy of a non-invasive technology which compares tones delivered to a subject’s brain guided by the brain’s own rhythms, versus random unguided tones. The research trial is being conducted in two locations–Uniformed Services University of the Health Sciences (USUHS) in Bethesda, MD; and Womack Army Medical Center (WAMC) in Fort Bragg, NC.

The impressive interim results to date, which are a combination of test and placebo, indicate a possible breakthrough for an intervention treating mTBI. Once completed, the data can be summarized in separate test and placebo results. The final report for results at the trial’s completion will provide definitive measures for the apparent positive changes seen to date.

In the United States, an estimated 190,000 individuals develop persistent symptoms each year following a concussion (mTBI). mTBI has been called the “signature injury” of the wars in Iraq and Afghanistan, with up to 80% of battle injuries attributable to concussive shock waves from an improvised explosive device (IED). Persisting symptoms after mTBI can cause debilitating conditions that may include sleep disturbance, anxiety and/or depression, foggy thinking, headaches, dizziness and behavioral issues. It’s generally accepted that Post-Traumatic Stress Disorder (PTSD) often co-occurs with persisting mTBI.

“Once we realized the prevalence of mTBI amongst servicemen, it became our duty to help these soldiers transition back to a functional and healthy brain potential” said Lee Gerdes, Cereset® Founder and CEO. “Cereset® is designed to alleviate the symptoms and negative effects of brain trauma, so individuals no longer feel stuck in a high-stress neurological environment, long after the battlefield. We’re pleased that the study is yielding positive results and that our technology is aiding the men and women who take on the selfless responsibilities of defending our country to be fully prepared for the next steps in their lives.”

Cereset Research technology has been used in clinical trials at Wake Forest School of Medicine under the direction of Doctor Charles Tegeler, Professor of Neurology. Doctor Tegeler’s findings with PTSD and athletes with persisting-post concussion symptoms were instrumental in securing a $2.8M grant from the Office of the Assistant Secretary of Defense for Health/Traumatic Brain Injury Research Program, under Award No. W81XWH-17-2-0057. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.

Wake Forest School of Medicine is collaborating in this research through Doctor Tegeler’s involvement as a Co-Investigator. Lee Gerdes, Cereset®/Brain State is the project’s Principal Investigator; Doctor Michael Roy is Principal Investigator at USUHS; and Doctor Wesley Cole is Principal Investigator at WAMC.

For more information on how to participate in the trial please visit cereset.com/research and clinicaltrials.gov/ct2/show/NCT03649958

About Cereset®
Founded in 2003 by Lee Gerdes, Cereset® is the global technology leader in helping your brain relax and reset itself, enabling individuals to achieve higher levels of well-being and balance. The company’s patented BrainEcho® technology uses auditory tones to reflect brain frequencies to create new neural pathways that reset the brain. Cereset® legacy technology has been licensed to over 200 affiliate centers in more than 18 countries to successfully empower more than 150,000 clients in North America and Europe. To schedule an appointment at a Cereset® office, or to learn more, visit cereset.com and watch vimeo.com/wearecereset/what-is-cereset

*Disclosure: Please be advised*
(1) "The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick MD 21702 5014 is the awarding and administering acquisition office" and;
(2) “This work was supported by the Office of the Assistant Secretary of Defense for Health Affairs through the Psychological Health/Traumatic Brain Injury Research Program under Award No. W81XWH-17-2 0057. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense."
(3) “In conducting research using animals, the investigator(s) adheres to the laws of the United States and regulations of the Department of Agriculture."
(4) “In the conduct of research utilizing recombinant DNA, the investigator adhered to NIH Guidelines for research involving recombinant DNA molecules."
(5) "In the conduct of research involving hazardous organisms or toxins, the investigator adhered to the CDC-NIH Guide for Biosafety in Microbiological and Biomedical Laboratories."

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Lee Gerdes, CEO
Cereset
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