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 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.
What is Traumatic Brain Injury?
Traumatic brain injury (TBI) occurs when a sudden physical assault on the head causes damage to the brain. The damage can be focal, confined to one area of the brain, or diffuse, involving more than one area of the brain. TBI can result from a closed head injury or a penetrating head injury. A closed head injury occurs when the head suddenly and violently hits an object, but the object does not break through the skull. A penetrating head injury occurs when an object pierces the skull and enters the brain tissue.
Why is the study being done?
The purpose of this study is to evaluate whether HBO can improve the symptoms of Traumatic Brain Injury. This research is being done because we are trying to identify whether HBO will increase blood flow in the brain and improve cognitive function.
Do I qualify for the hyperbaric study?
You may qualify for the clinical trial if you meet the following Inclusion criteria:
What is involved in the study?
Treatment will be evaluated after each set of 40 HBO sessions. Treatment will stop if no improvement is seen on the SPECT scan, cognitive assessment, physical evaluation, or you decide to stop. Follow-up SPECT scan and cognitive assessments at 3 months post-treatment may be requested.
How long will I be on the study?
If the SPECT scan and cognitive assessment show improvement after each set of 40 HBO sessions, you may be in the study for up to 120 HBO sessions (at a maximum of 5 sessions per week) or until you decide to stop. It is anticipated that most TBI will show signs of improvement after 40 HBO sessions. A final SPECT scan and cognitive assessment at 3 months post-treatment may be requested.
What are the potential costs?
Total estimated self-pay patient cost is approximately $75,000 if all 120 hyperbaric treatments and the follow-up exams are completed. Insurance does not cover this treatment.
Taking part in this study may result in added costs to you.
Financial assistance may be available if you qualify. Financial assistance is need-based. A financial counselor is available to assess whether you qualify for financial assistance. All assets as well as gross family income will be evaluated. The clinical research staff can assist you in setting up an appointment with the financial counselor.
What are the benefits of participating in the study?
If you agree to take part in this study, there may or may not be a direct medical benefit to you. We hope the information learned from this study will benefit TBI patients in the future.
What are the potential risks of the study?
Under proper supervision, the risks of HBO are minimal. The most common side effect is ear pain, and patients are monitored closely for this issue. Rarely (less likely, but serious), oxygen toxicity (high concentration of oxygen that can damage cells), pulmonary barotrauma (lung injury caused by pressure) and vision change may be experienced.
*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.