Long-term survival of participants in the CENTAUR trial of sodium phenylbutyrate-taurursodiol in amyotrophic lateral sclerosis.

An orally administered, fixed-dose coformulation of sodium phenylbutyrate-taurursodiol (PB-TURSO) significantly slowed functional decline in a randomized, placebo-controlled, phase 2 trial in ALS (CENTAUR). Herein we report results of a long-term survival analysis of participants in CENTAUR. In CENTAUR, adults with ALS were randomized 2:1 to PB-TURSO or placebo. Participants completing the 6-month (24-week) randomized phase were eligible to receive PB-TURSO in the open-label extension. An all-cause mortality analysis (35-month maximum follow-up post-randomization) incorporated all randomized participants. Participants and site investigators were blinded to treatment assignments through the duration of follow-up of this analysis. Vital status was obtained for 135 of 137 participants originally randomized in CENTAUR. Median overall survival was 25.0 months among participants originally randomized to PB-TURSO and 18.5 months among those originally randomized to placebo (hazard ratio, 0.56; 95% confidence interval, 0.34-0.92; P = .023). Initiation of PB-TURSO treatment at baseline resulted in a 6.5-month longer median survival as compared with placebo. Combined with results from CENTAUR, these results suggest that PB-TURSO has both functional and survival benefits in ALS.

Patient Profiles of Criminal Behavior in the Context of Traumatic Brain Injury.

Traumatic brain injury (TBI) can lead to significant post-traumatic disturbances in mood and behavior, with the frontal lobes playing a key role in emotional and behavioral regulation. Injury to the frontal lobe can result in disinhibition and aggression which can result in police intervention and/or incarceration. We highlight four adult cases with a history of severe TBI with frontal lobe injuries and the presence of post-TBI criminal behaviors. There is evidence to support an anatomical basis for aggressive behaviors, yet there are other risk factors to be considered. Behaviors must be investigated thoroughly by obtaining adequate pre- and post-TBI psychiatric and psychosocial histories. By having a comprehensive understanding of aggression while appreciating the complex relationship between TBI, aggression, and premorbid risk factors, clinicians can more adequately treat patients with TBI, with the aim of potentially preventing criminal behaviors and recidivism.

Efficacy of legal judgments for defendants with traumatic brain injury.

BACKGROUND: Literature has compared the frequency of aggressive behaviors of the TBI population and the non-TBI population, suggesting that the TBI population is predisposed to aggressive tendencies because the injury enables impulsivity, loss of self-control, and the inability to modify behaviors. These behavior changes have consequently, been found to lead to criminal involvement. In fact, the majority of the prison population has sustained at least one TBI in their lifetime compared to the prevalence of brain injuries in the general population. However, there is little research investigating the perceptions of criminality and guilt of these individuals. METHODS: Two experiments were conducted that investigated the perceptions of morality, level of guilt, and appropriate sentencing of crimes committed by defendants with different severities of TBI (i.e., mild, severe, and no TBI). Participants were asked to read scenarios about crimes being committed by the defendant. Experiment 1 used a 1-between (crime), 1-within (TBI) mixed design ANOVA testing three dependent variables (morality, guilt, and sentencing). Using a more in vivo jury approach, Experiment 2 used a 3 (TBI)×2 (crime) independent groups factorial design testing the three dependent measures. RESULTS: Overall, defendants with TBI were found less guilty of their crime, perceived as behaving morally to the crime, and receiving a milder punishment relative to the no-TBI defendants. CONCLUSIONS: In the courtroom, the defense attorney should educate the judge and/or the jury on the effects brain injuries have on the cognition, behavior, and emotions of an individual. Thus, this education will ensure the best verdict is being reached.

Efficacy of self-perception after traumatic brain injury.

BACKGROUND: Anosognosia is a lack of awareness of personal deficits that is commonly observed in people with a traumatic brain injury (TBI). OBJECTIVE: The purpose of this paper is to examine whether self-appraisal of executive functioning differs for students with and without TBI. METHODS: Students who had survived a TBI and those who had never had a TBI filled out the Behavior Rating Inventory of Executive Functioning from three different perspectives. Each participant was paired with an observer who was familiar with the person's behavior. Self-appraisal ratings, observer ratings of the participant, and reflective appraisal of how the participant thought the observer would rate them were compared. RESULTS: For the students without TBI, reflective appraisal was significantly correlated with self-appraisal but observer appraisal was not. For students with TBI, neither reflected appraisal nor observer appraisal correlated with self-appraisal. Both TBI and non-TBI participants overestimated their problems on measures of Inhibition, Shifting, Emotional Control, Initiation, and Planning/Organizing. TBI participants underestimated their problems on measures of Working Memory, Organization, and Task Monitoring relative to the non-TBI group. CONCLUSIONS: Students with TBI do not accurately perceive how others perceive their behavior.