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Brain Injuries clinical trials

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NCT ID: NCT01366820 Completed - Brain Injuries Clinical Trials

Study of NNZ-2566 in Patients With Traumatic Brain Injury Under EFIC

INTREPID2566
Start date: February 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether NNZ-2566 is safe and effective in the treatment of Traumatic Brain Injury (TBI).

NCT ID: NCT01363583 Completed - Clinical trials for Traumatic Brain Injury

Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury

Start date: January 2002
Phase: Phase 1
Study type: Interventional

This study is a prospective consecutive double-blinded randomized study on the effect of PGI2, prostacyclin (epoprostenol, Flolan®) versus placebo (saline)in patients with severe traumatic brain injury. All patients with severe traumatic brain injury were eligible for inclusion. Inclusion criteria: verified traumatic brain injury, Glasgow Coma Score (GCS) at intubation and sedation of ≤ 8, age 15-70 years, a first-recorded cerebral perfusion pressure (CPP) of > 10 mm Hg, and arrival within 24 hours after trauma. Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a lactate/pyruvate ratio,as measured by cerebral microdialysis after 24 hours of treatment. A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers, measured by different cytokines.

NCT ID: NCT01354509 Recruiting - Clinical trials for Traumatic Brain Injury

Normothermia Protocol for Traumatic Brain Injury Patients

Start date: May 2011
Phase: N/A
Study type: Observational

Comparison between a normothermia protocol and current protocol (acetaminophen plus blankets) 1. Normothermia Protocol is successful in achieving and maintaining normal temperature in moderate to severe Traumatic Brain Injury (TBI) patients.(using Arctic Sun for 96 hrs from admission to Neuro ICU) 2. Normothermia is translated into improved neurologic Outcome and survival compared to standard of care (Physician management)

NCT ID: NCT01343862 Not yet recruiting - Clinical trials for Traumatic Brain Injury

The Effect of Single Dose D-Cycloserine on Cognitive Outcome in Moderate Traumatic Brain Injury (TBI) Patients

DCS
Start date: August 2011
Phase: Phase 2
Study type: Interventional

In this study of patients with moderate traumatic brain injury with frontal brain contusions patients will be randomized to treatment with a single dose of either D-cycloserine or placebo given 48-72 hours after injury. Patients will undergo intensive neurocognitive testing at 3 and 6 months after injury to assess whether treatment with a single dose of D-cycloserine improves cognitive outcome after moderate brain injury.

NCT ID: NCT01343329 Withdrawn - Clinical trials for Traumatic Brain Injury

Controlling Hyperadrenergic Activity in Neurologic Injury

CHAIN
Start date: July 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Traumatic brain injury (TBI) is frequently associated with a hyperadrenergic state accompanied by elevated levels of plasma catecholamines. In its more severe presentation, the hyperadrenergic state presents as dysautonomia, which is characterized by paroxysmal alteration in vital signs, including tachycardia. The investigators hypothesize that intravenous (IV) esmolol is as effective at controlling heart rate in hyperadrenergic states as oral propranolol, which is the standard of care. Our primary endpoint is efficacy of IV esmolol vs a PRN regimen of intermittent B-blockade in controlling heart rate below a pre-specified level (< 100 bpm) after Traumatic Brain Injury (TBI) or hemorrhagic neurologic injury. Heart rates will be recorded continuously as well as hourly.

NCT ID: NCT01339806 Completed - Clinical trials for Traumatic Brain Injury With Brief Loss of Consciousness

The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury

SCORE
Start date: June 2011
Phase: Phase 4
Study type: Interventional

The objective of this trial is to evaluate the effectiveness of cognitive rehabilitation in OIF/OEF service members with a history of mild traumatic brain injury and persistent (3-24 months post injury) cognitive complaints. This is a prospective, randomized, control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study. Subjects will be evaluated prior to the start of treatment and 3, 6, 12, and 18 weeks following the initiation of the study. The total number of patients to be studied is 160 (maximum), which is approximately 20 patients per month.

NCT ID: NCT01339702 Completed - Clinical trials for Brain Injuries, Traumatic

The EPIC Project: Impact of Implementing the EMS Traumatic Brain Injury Treatment Guidelines

EPIC
Start date: September 2011
Phase:
Study type: Observational

Evaluation of the impact (on survival and other outcomes) of implementing the Brain Trauma Foundation/National Association of EMS Physicians Traumatic Brain Injury (TBI) guidelines in the prehospital EMS systems throughout the state of Arizona.

NCT ID: NCT01338701 Completed - Clinical trials for Traumatic Brain Injury

Exploratory Study to Evaluate 2 Acupuncture Methods for the Treatment of Headaches Associated With TBI

Start date: February 2011
Phase: Phase 2/Phase 3
Study type: Interventional

This study investigates whether acupuncture can help to decrease the number and severity of headaches in people who have Traumatic Brain Injury. The aim of this study is to compare two different types of acupuncture—either Traditional Chinese Acupuncture or ear acupuncture—to a group that receives no acupuncture at all. Acupuncture has been demonstrated to reduce pain, improve health-related quality of life, prevent migraine headaches, and improve tension and chronic daily headaches.

NCT ID: NCT01336413 Completed - Clinical trials for Brain Injuries, Traumatic

Neuroactive Steroids and Traumatic Brain Injury (TBI) in OEF/OIF Veterans

Start date: October 2013
Phase: Phase 2
Study type: Interventional

Purpose: Mild traumatic brain injury (TBI) is extremely common among Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) era Veterans. Mild TBI is frequently accompanied by post-traumatic stress disorder (PTSD) and depression symptoms, co-occurring disorders that contribute to increased disability and decreased quality of life. Neuroactive steroids (NS) represent promising pharmacological candidates for intervention for these diverse symptom domains, since a number of these molecules demonstrate pronounced neuroprotective and neurotrophic properties. The NS pregnenolone (PREG) is a logical therapeutic option, since it enhances learning and memory and also increases myelination in rodent models. Further, decreases in PREG have been associated with depressive symptoms, and PREG is also metabolized to allopregnanolone (ALLO), an anxiolytic downstream NS that is decreased in PTSD. ALLO also enhances neurogenesis in rodents. The investigators thus propose an randomized controlled trial (RCT) in OEF/OIF era Veterans with mild TBI. Methodology: The design of this study will be randomized, placebo-controlled, double-blind. Trial duration will be 10 weeks, consisting of a 2-week placebo lead-in period for all subjects, followed by 8 weeks of treatment with either pregnenolone or placebo. The primary cognitive outcome measure will be executive functioning (as assessed by the Tower of London test), and the primary behavioral outcome measure will be PTSD Cluster D symptoms (as assessed by the Clinician-Administered PTSD Scale, CAPS). The investigators will also determine if PREG administration in OEF/OIF Veterans with mild TBI increases downstream ALLO and/or other GABAergic NS levels, and the investigators will identify the specific metabolism profile of PREG following eight weeks of treatment with this neurosteroid. Anticipated Findings: The investigators hypothesize that treatment with PREG in OEF/OIF era Veterans with mild TBI will significantly improve executive functioning compared to the placebo condition. The investigators also predict that treatment with PREG will decrease Cluster D PTSD symptoms compared to treatment with placebo.

NCT ID: NCT01334528 Completed - Clinical trials for Mild Traumatic Brain Injury

Consistency of Automated Neuropsychological Assessment Metrics (ANAM) Performance in Those With Deployment Acquired Mild Traumatic Brain Injury (TBI)

ANAM
Start date: February 2011
Phase: N/A
Study type: Observational

The purpose of this project is to explore the degree to which performance consistency on neuropsychological measures varies in a sample of Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) Veterans with a history of mild traumatic brain injury (mTBI) with persistent self-reported symptoms.