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Traumatic Brain Injury clinical trials

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NCT ID: NCT01202110 Terminated - Clinical trials for Traumatic Brain Injury

Early Propranolol After Traumatic Brain Injury: Phase II

EPAT: Phase II
Start date: June 2010
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine in patients with traumatic brain injury (TBI) the safe dosing of propranolol. Safety will be measured by episodes of bradycardia (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) that are refractive to Brain Trauma Foundation guidelines for treatment. A no-treatment arm will establish the number of episodes of bradycardia, hypotension and reduced cerebral pressure refractory to treatment that occur without propranolol.

NCT ID: NCT01111682 Terminated - Clinical trials for Traumatic Brain Injury

Hypertonic Saline vs. Mannitol for Elevated Intercranial Pressure

Start date: April 2010
Phase: Phase 3
Study type: Interventional

This study examines the role of osmotic agents in controlling brain swelling in brain injured individuals. Two osmotic agents -- mannitol and hypertonic saline -- are in common use, and they will be compared in the context of a randomized clinical trial. The goal is to determine if these agent differ in their ability to control episodes of brain swelling.

NCT ID: NCT01110187 Terminated - Clinical trials for Traumatic Brain Injury

A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

Start date: May 2010
Phase: N/A
Study type: Interventional

Trial 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.

NCT ID: NCT01105962 Terminated - Clinical trials for Traumatic Brain Injury

Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder

NBIRR-1
Start date: May 2010
Phase: N/A
Study type: Observational

This is an observational research study whose purposes are to see: 1. if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or 80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder). 2. if improvements or worsening of symptoms can be recorded with computerized and written tests for memory and thinking, and with questionnaires about the subject's quality of life and health. 3. determine the long-term outcome of the treatment. 4. confirm, in large numbers of study participants at multiple sites nationwide, the strong positive results obtained in pilot studies

NCT ID: NCT01048138 Terminated - Clinical trials for Traumatic Brain Injury

Use of Biperiden for the Prevention of Post-traumatic Epilepsy

Start date: January 31, 2018
Phase: Phase 3
Study type: Interventional

There is no AED or medication that has been demonstrated to affect the development of post-traumatic epilepsy. Biperiden is a cholinergic antagonist, acting in the muscarinic receptor, that is widely used as an anti Parkinson drug. The investigators data with animal models of epilepsy indicate that anti-muscarinic agents might affect the natural course of the disease in the case of post-traumatic epilepsy.

NCT ID: NCT01028339 Terminated - Clinical trials for Traumatic Brain Injury

Mannitol vs HS to Treat ICHT After Severe TBI : Comparison on PtiO2 and Microdialysis Values

Start date: July 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether hypertonic saline is as much effective as mannitol to treat intracranial hypertension after traumatic brain injury and has at least the same effects on PtiO2 and cerebral metabolism studied through microdialysis.

NCT ID: NCT00983437 Terminated - Clinical trials for Traumatic Brain Injury

Study to Evaluate the Safety, Tolerability, and Efficacy of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

Start date: August 31, 2009
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).

NCT ID: NCT00940615 Terminated - Clinical trials for Traumatic Brain Injury

The Effect of Aerobic Exercise on Mild Traumatic Brain Injury

Start date: September 2009
Phase: N/A
Study type: Interventional

The current project will examine the effects of aerobic exercise on cognition among a group of veterans who have suffered a mild traumatic brain injury.

NCT ID: NCT00918970 Terminated - Clinical trials for Traumatic Brain Injury

Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death

MEANS
Start date: August 2008
Phase: N/A
Study type: Observational

Context: A major lack of organ donors is a serious public health problem. It determines a prolonged delay before a transplant can be performed and thus a significant number of deaths of patients waiting for transplantation. The aim of this project is to reduce the delay of the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit. The diagnosis of brain death is strictly defined by the law and relies either on two consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack of cerebral circulation during a brain angiography performed after suspecting brain death on the clinical exam. However, in usual practice, it is difficult to have all the needed clinical arguments, and their interpretation can be difficult in the pathological context. This may participate in the delay and the lack of patients potentially donors. Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous ECG recording. The investigators could find that a decrease in autonomic nervous system activity, as measured through the ECG, was correlated to the transition to brain death assessed by cerebral angiography. The loss of cardiac variability was always observed between two cerebral angiographies, one before and the second after brain death. This study allowed the investigators to calculate the threshold values of sympathetic and parasympathetic activities to confirm brain death.

NCT ID: NCT00908063 Terminated - Clinical trials for Traumatic Brain Injury

Safety and Tolerability of Oxycyte in Patients With Traumatic Brain Injury (TBI)

STOP-TBI
Start date: October 2009
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of a single administration of Oxycyte in patients with severe non-penetrating traumatic brain injury (TBI). In the first dose level (Cohort 1), 11 patients were randomized 2:1 to receive either 1.0 mL/kg Oxycyte (0.6 g/kg; n=8) or NS (n=3). A total of 8 patients received Oxycyte. The Data Safety Monitoring Board (DSMB) reviewed the safety data for patients in Cohort 1 through Day 14, and approved escalation to the next dose. In Cohort 2, 18 patients will be randomized 2:1 to receive either 2.0 mL/kg Oxycyte (1.2 g/kg; n=12) or NS (n=6). The DSMB will then review the safety data for all patients in Cohort 2 through Day 14 and either approve escalation to the highest dose or remain at the current dose. If remaining at the current dose level (Cohort 2) an additional 50 patients will be randomized 1:1 to Oxycyte (n=25) or NS (n=25) and treated. If escalation occurs to Cohort 3, 18 patients would be randomized 2:1 to Oxycyte (n=12) or NS (n=6) to receive the 3.0 mL/kg dose. The DSMB would again review the safety data and decide whether to treat an additional 50 patients at this dose or to decrease the dose back to 2.0 mL/kg. This group would be randomized 1:1 to receive Oxycyte (n=25) or NS.