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Closed-Loop Deep Brain Stimulation Successfully Modulates Hippocampal Activity in an Animal Model

time of injury (Figure). A favorable outcome was determined by stratifying patients according to the severity of their initial injury so that patientswith a less severe initial injury had to have a better recovery than those with amore severe injury to have a favorable outcome.A total of 882 patientswere randomized between April 2010 and October 2013. The progesterone and placebo groupswere balanced in terms of demographics and injury severity; 53.5% of patients had an initial GCS score of 5 to 8, with the remainder divided between a GCS score of 4 (severe injury) and a GCS score of 9 to 12 (moderate injury). Favorable outcomes were achieved in 51.0% of progesterone-treated patients and 55.5%of placebo patients. A secondary analysis in which a favorable outcome was simply considered to be an Extended Glasgow Outcome Scale score $5 (equating to moderate disability or better) provided similar results. There was also no significant difference in mortality between the 2 groups. Additionally, adverse events were similar between the groups with the exception of phlebitis and thrombophlebitis (considered a nonserious adverse event) occurring significantly more often in the progesterone group. Thus, although progesterone maintains a good safety profile, it does not appear to have an effect on functional outcome when administered to patients with acute TBI. Despite data frommultiple animal studies, 2 human trials preceding it, and a high-quality study design, the PROTECT III trial was not able to establish a role for progesterone in the treatment of TBI. The authors cite the heterogeneity of injuries, patient pre-existing conditions, and the characteristics of individual patients as potential confounding factors. Although these negative results are disappointing, the study paves the way for the investigation of future compounds.