“Concussion pill” on horizon as World Brain Day marked

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File image. © Mike Bain

A combination of Cannabidiol (CBD) and an anesthetic is showing promise in reducing post-injury brain cell inflammation, headache, pain and other symptoms associated with concussion.

A pre-clinical pilot study by researchers at the University of Miami into a combination of CBD (a cannabinoid derivative of hemp) with an NMDA antagonist (an anesthetic used in animals and humans) for the treatment of traumatic brain injury and concussion showed that the combination therapy improved the cognitive functions of animals, compared with those treated with a single vehicle. In addition, there were no adverse effects from either the combination therapy or the individual components.

Scythian Biosciences gave $16 million to the Miamis’ Miller School of Medicine for the five-year study, with researchers believing the combination could reduce post-injury brain cell inflammation, headache, pain and other symptoms associated with concussion.

The study findings were released only days before World Brain Day, which has been marked annually on July 22 by the World Federation of Neurology (WFN). About 120 organisations around the world participate in this awareness-raising initiative, which is devoted to a different topic each year. This year’s theme is “Clean Air for Brain Health”; recent estimates put the annual number of deaths attributable to polluted air at 9 million worldwide.

Dr. Gillian Hotz
Dr. Gillian Hotz

Neurological surgery professor Gillian A. Hotz, lead investigator of the Miller study, said there needed to be more systematic research to study the neuroprotective properties of CBD, and to improve treatment for those sustaining mild-to-moderate TBI (traumatic brain injury) and concussion.

She said the next phase of research would involve a small human pilot study, likely administering the compounds in pill form to a control group and two groups of TBI patients, acute and chronic. Researchers will use nine outcome fields — cognitive, behavioral, psychosocial, sleep, pain, sensorimotor, cardiovascular, inflammatory biomarkers, and neuroimaging studies — to evaluate the drug’s efficacy. Once the study is completed, the data will be analyzed and any safety concerns will be addressed.

If the treatment is deemed safe and effective, the third phase of the research will be to begin a full-scale clinical trial over the next three years. With FDA oversight, data will reveal whether the compound is an effective therapeutic treatment for those suffering from different severities of TBI and concussion.

Traumatic brain injury is a major cause of death and disability in the United States, contributing to about 30 percent of all injury deaths and impacting about two million children and teenagers annually, according to the Centers for Disease Control and Prevention. Most of these individuals face short-term effects such as headaches and dizziness, while others are at increased risk for longer-term chronic medical problems, including disorders of attention, memory, anxiety, depression and dementia.

Holz is director of the KiDZ Neuroscience Center at The Miami Project and the University of Miami Sports Medicine Institute concussion program. Her team had developed a concussion protocol including education and training for doctors and trainers in an effort to provide a solution to the growing concern of managing concussions in sports. But one thing has eluded the team: “A clinically proven medication to treat concussion. Whether or not this study leads to a pill that could treat concussion, this type of research will pave the way for UM and other researchers to better manage concussion.”

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