Millions of persons every year are affected by traumatic brain injury (TBI), and currently no therapies have shown efficacy in improving outcomes clinically. Recent research has suggested that enriched environments (EE), embryonic neural stem cells (eNSC), and progesterone (PROG) improve functional outcomes after TBI, and further, several investigators have suggested that a polytherapuetic approach may have greater efficacy than a single therapy. The purpose of the current study was to determine if varying combinations of post-injury EE, progesterone therapy, or eNSC transplantation would improve functional outcomes over just a single therapy. A controlled cortical impact was performed in rats to create a lesion in the medial frontal cortex. The rats were then placed in either EE or standard environments and administered 10 mg/kg progesterone or vehicle injections 4 h post-injury and every 12 h for 72 h after the initial injection. Seven days after the surgery, rats were transplanted with either eNSCs or media. Rats were then tested on the open field test, Barnes maze, Morris water maze, and Rotor-Rod tasks. Improved functional outcomes were shown on a majority of the behavioral tasks in animals that received a combination of therapies. This effect was especially prominent with therapies that were combined with EE. Immunohistochemistry showed that the transplanted eNSCs survived, migrated, and displayed neural phenotypes. These data suggest that a poly-therapeutic approach after TBI improves functional recovery to a greater magnitude. Moreover, when polytherapies are combined with EE, the effects on recovery are enhanced, leading to greater recovery of function.

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BACKGROUND Over the last decade the use of electronic nicotine delivery systems (ENDS) has been on the rise, while studies which describe how consumers use these products have been limited. Most studies related to the use of ENDS products have primarily involved study designs focused on use in a central location environment, providing only a snapshot of use behavior at a specific moment in time. The development of accurate and reliable data collection methods, generation of operational definitions for novel endpoints, and expansion of primary endpoints beyond those traditionally used for combustible cigarettes to reflect the additional complexity of ENDS use behavior may allow for a better understanding of how patterns of ENDS use change over time. OBJECTIVE The Product Use and Behavior (PUB) instrument was developed and used to capture the use of Vuse Solo in an ambulatory setting to best replicate real-world use behavior. METHODS A prospective ambulatory clinical study was performed with the PUB instrument. Participants were between the ages of 21 and 60, considered in good health, and were required to be established regular users of ENDS. A novel analytical approach was employed to define sessions of use with ENDS and to better understand use across the sample population. By combining this technology with a novel analytical approach, we were able to define sessions of use with an ENDS product. RESULTS This approach allowed us to determine traditional topography endpoints such as total puffs, mean puff duration, and inter-puff interval while also determining novel session-related endpoints including puffs per session, time between sessions, sessions per day, and session length. CONCLUSIONS Collecting topography data in an ambulatory setting and understanding product use in the context of sessions allows for a more complete understanding of ENDS use patterns. This approach to capturing and analyzing ENDS data provides a better understanding of the potential impact the use of ENDS products on public health. CLINICALTRIAL NCT04226404

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