Bringing relief to those suffering from PTS and TBI.
What is Gemini?
Gemini is the pilot program One Mind created to support its approach that large research studies combined with our open science principles will greatly accelerate the discovery of better diagnostics, treatments and, someday, cures for diseases and injuries of the brain.
How does the program work?
Gemini has three supported projects that are clinical studies for post-traumatic stress (PTS) and traumatic brain injury (TBI):
TRACK-TBI – a national collaboration between 11 research universities whose Level I Trauma Centers will enroll 3,000 patients in the largest longitudinal study of TBI ever undertaken. The first patient enrolled in February 2014.
TED INITIATIVE – a DoD-funded collaboration between TRACK-TBI, the FDA, the Chronic Effects of Neurotrauma Consortium (CENC), and the Concussion Research Consortium (CRC) for advancing diagnosis and treatment of TBI. Data will be collected to identify and validate effective measures of brain injury and recovery.
CENTER-TBI – a European observational study focused on 60 sites in 20 countries, with the aim to better characterize TBI that will include data collected from nearly 6,000 patients from three strata: patients seen in the ER, patients admitted to hospital and patients admitted to an ICU ward. In addition, a registry of around 25,000 subjects will be established.
These databases will be available, and of particular value to those researching diseases and injuries sharing similar biological characteristics.
What are the results so far?
To date, the TRACK-TBI study sites have enrolled more than 2,150 patients and conducted follow-up visits. This rate of enrollment is unprecedented for TBI clinical studies and we anticipate reaching the total subject enrollment of 3,000 patients.
Not surprisingly, these patients have a wide range of injuries, and assessments are often limited as they are in various stages of recovery along with balance, memory, emotional, financial and other problems as a consequence of their TBI.
With additional funding from One Mind, the TRACK-TBI study teams are now able to provide transportation, adequately reimburse and provide a meal or snack to help get their patients through the long hours that it takes to complete a comprehensive evaluation.
The support from One Mind has already led to an exceptional number of patients getting follow-up MRIs. It is clear that this additional support is making an important difference on the patient follow-up rates, which is fundamental to the success of this research. One Mind will continue working to fill the funding gaps for the TRACK-TBI initiative.
CENTER-TBI began accepting patients in December 2014 and as of February 2017, enrollment rates have been high with over 3,900 patients entered into the Core Data collection and over 17,600 patients entered into the Registry at 65 active study sites across Europe. Data collection is continuing and outcome assessment will end in late 2017.
One Mind has provided support to build the CENTER-TBI data infrastructure, which was not included in the EU funding. In addition, One Mind provided neuro-informatic support to integrate data from multiple countries with different languages at the International Neuro-Informatics Coordinating Facility (INCF) in Stockholm.