Traumatic brain injury (TBI) is one of the leading, undiagnosed brain injuries in the United States. Victims experience symptoms of confusion, loss of memory, slurred speech and seizures. Those living with TBI struggle with its devastating effects for days, months, years or even for the rest of their lives. Regardless of age, anyone can suffer a detrimental brain injury, including professional athletes, motorcyclists, children involved in team sports, military personnel and even senior citizens.
The scope of traumatic brain injury is far-reaching and the effects are substantial. TBI occurs when a sudden physical assault on the head causes damage to the brain. The damage can be focal, confined to one part of the brain, or diffuse, involving more than one area of the brain.
An estimated 1.7 million people sustain a traumatic brain injury annually in the United States. While 52,000 people die, 275,000 are hospitalized and 1.4 million (nearly 80%) are treated and released from an emergency department. Traumatic brain injury is a contributing factor to nearly a third (30.5%) of all injury-related deaths in the United States.
The Centers for Disease Control and Prevention estimate the following:
A vast number of articles and research studies have been published about the debilitating effects of traumatic brain injury. One theme is consistent—there is a major epidemic occurring relating to TBI, however, few treatment options are available.
In 2014, Jupiter Medical Center received FDA approval to open a clinical research trial that aims to combat the devastating effects of TBI. Under the leadership of Barry Miskin, MD, Principal Investigator, and Lee Fox, MD, Sub-Investigator, the clinical trial is a way to determine if hyperbaric oxygenation could be a leading-edge treatment option for brain injury patients.
Over the past decade, there have been clinical studies undertaken to evaluate the use of HBOT in the treatment of TBI. The research at Jupiter Medical Center is designed to test the overarching hypothesis that patients with traumatic brain injury treated with HBOT will show improvement in function and an increased blood flow, as evidenced by a single-photon emission computed tomography (SPECT) scan. Improvement is evidenced by an increased number of pixels on SPECT scans and increased brain metabolism. Improvement may also be identified via cognitive assessments administered by the Jupiter Medical Center Research Department.
Jupiter Medical Center has a long-established HBOT program on the hospital campus that utilizes a Monoplace, the largest, single-person pure oxygen chamber available. The program is supervised by a trained and experienced HBOT team of physicians and nurses.
Clinical Trial JMC-TBI-001
Under the guidance of the Food and Drug Administration (FDA), Jupiter Medical Center’s new clinical trial will test the use of HBOT to determine if oxygenation can stimulate the healing process of brain injuries. The research team will carefully screen each patient for preexisting characteristics and administer HBOT using a highly standardized protocol. To be eligible for the trial, patients must be 18 years of age or older and have experienced brain injury, including loss of consciousness.
The protocol includes patients receiving a total of 40 to 120 HBOT treatments based on the severity of their brain injury. These treatments are intense, with 1.5 ATA (atmospheres absolute) administered five times per week.
Phases I and II of the clinical trial will include 100 patients to establish efficacy through data.
Phase III will take place upon successful completion of Phases I and II. This trial will be conducted nationally with 1,000 patients, and it will incorporate changes learned in the previous trials to provide a greater statistical significance of efficacy. This larger trial will include partners such as universities and hospitals throughout the country.
*Source: Centers for Disease Control and Prevention (CDC), National Center for Injury Prevention and Control. Guide to Writing About Traumatic Brain Injury in News and Social Media.Atlanta (GA): Centers for Disease Control and Prevention; 2015.