Treatment of Social Competence After Traumatic Brain Injury
Traumatic Brain InjuryThe aim of this study is to determine the effectiveness of holistic group treatment program (called Group Interactive Structured Treatment, or GIST) to improve social communication skills for individuals with Traumatic Brain Injury. Hypothesis: Compared to an alternative intervention, those receiving the GIST intervention will show improved social competence, improved quality of life, and stronger group cohesion.
Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers
Traumatic Brain InjuryStrokeThe primary objective of this study is to evaluate the safety and tolerability of different dose levels of glyburide for injection, administered as a bolus dose followed by a 3-day continuous infusion. The secondary objectives are to assess the pharmacokinetics (PK) of glyburide and blood glucose and serum insulin pharmacodynamic (PD) responses to glyburide.
A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide
Traumatic Brain InjuryTrial to determine if seizure prophylaxis with IV LCM in NSICU patients experiencing mental status changes due to severe traumatic brain injury (sTBI) will result in improved short- and long-term outcomes and better immediate adverse effects when compared to the current standard of care anticonvulsant (IV fPHT) and will be at least as effective as IV fPHT in preventing clinical and sub-clinical seizure activity.
Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury...
Brain InjuriesThe SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.
Mindfulness-Based Cognitive Therapy Intervention to Treat Depression in Individuals With a Traumatic...
DepressionTraumatic Brain InjuryThe purpose of this study is to determine whether mindfulness-based cognitive therapy is effective in reducing depression symptoms in individuals who have experienced a traumatic brain injury. The investigators hypothesize that participants who are given the ten-week intervention will have fewer depression symptoms than the participants in the control group, and this improvement will be maintained at the three-month follow-up assessment.
Safety Study of NNZ-2566 in Healthy Female Subjects
Brain InjuriesTraumaticThe purpose of this study is to obtain evidence of the safety of NNZ-2566 in healthy female volunteers and to determine the pharmacokinetics (PK) of NNZ-2566 in healthy female volunteers.
Safety and Feasibility of Minocycline in the Treatment of Traumatic Brain Injury (TBI)
Traumatic Brain InjuryThe purpose of this study is: To assess the safety and feasibility of minocycline administration after TBI in a dose escalation study at two different doses over 7 days. To assess the pharmacokinetic characteristics of two different dosing regimens of minocycline in TBI patients, the effect on biochemical markers of neuroprotective mechanisms, and effect on neurobehavioral and functional outcome. To begin initial assessment of the efficacy of minocycline as a therapeutic agent for severe human TBI.
Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury...
AnemiaTraumatic Brain InjuryThe purpose of this study is to determine the effect of early administration of recombinant human erythropoietin on long-term neurological outcome after severe traumatic brain injury.
Study of Modafinil to Treat Fatigue in Persons With Traumatic Brain Injury
FatigueThe purpose of this study is to determine whether Modafinil is effective in: (1) reducing fatigue and excessive daytime sleepiness (EDS) in individuals with Traumatic Brain Injury (TBI); and (2) improving cognitive function and quality of life in individuals with TBI.
Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain...
Traumatic Brain InjuryNightly administration of a unique, sublingual (under the tongue) formulation of tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve sleep and next-day functioning in CP (cerebral palsy) patients. It is hypothesized that this improvement in sleep efficiency (i.e.,fewer wake episodes, longer time asleep, etc.) with resulting improvement in quality-of-life (i.e.,improvements in next-day functioning, cognition and movement) may also be seen in a similar patient population, i.e., children with traumatic brain injury (TBI).