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Brain Injuries clinical trials

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NCT ID: NCT02452541 Active, not recruiting - Clinical trials for Traumatic Brain Injury

TBI-Prognosis Multicenter Prospective Study

Start date: April 2013
Phase: N/A
Study type: Interventional

Severe traumatic brain injury (TBI) is the leading cause of death and disability among people under 45 years of age and a major public health problem. Although management of severe TBI patients has gradually improved with the establishment of intensive care units (ICU) and the development of practice guidelines, mortality is still high - ranging from 30 to 50% - with 30% of survivors suffering from severe neurological sequelae such as neurovegetative states. Families and medical teams are frequently called upon to determine reasonable and appropriate goals of care for brain injured patients. They may have to consider high intensity of care, but also the withdrawal of life-sustaining therapies in accordance with patient wishes. Physicians involved in the care of severe traumatic brain injury have expressed serious concerns about hasty decisions made in the absence of appropriate evidence of unfavourable prognosis. The purpose of the TBI-Prognosis study is to develop a prognostic model by using a multimodal approach of different prognostic indicators and their evolution over time in the acute phase of care. The results of this study will provide better objective information that will facilitate the shared-decision making-process with families and relatives.

NCT ID: NCT02404402 Active, not recruiting - Clinical trials for Traumatic Brain Injury

LED Treatment to Improve Cognition and Promote Recovery in TBI

LED-TBI
Start date: May 1, 2015
Phase: N/A
Study type: Interventional

This study investigates the efficacy of a novel neuromodulation treatment, light emitting diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with traumatic brain injury (TBI).

NCT ID: NCT02391402 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Cognitively Augmented Behavioral Activation for Veterans With Comorbid TBI/PTSD

CABA
Start date: May 4, 2015
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of Cognitively Augmented Behavioral Activation (CABA), a new hybrid treatment for Veterans diagnosed with comorbid mild Traumatic Brain Injury (mTBI) and posttraumatic stress disorder (PTSD). The study's specific goals are to determine whether: 1) CABA reduces PTSD symptoms in Veterans with mTBI/PTSD, 2) CABA reduces cognitive-related functional impairment in Veterans with mTBI/PTSD, 3) CABA results in improvements in depression symptoms, cognitive functioning, and quality of life in Veterans with mTBI/PTSD; and 4) CABA is an acceptable treatment for Veterans with mTBI/PTSD. The overall goal is to develop an evidence-based manualized treatment for comorbid mTBI/PTSD that can be readily implemented in Veterans Health Administration (VHA) treatment settings.

NCT ID: NCT02292589 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Brain Stimulation for Mild Traumatic Brain Injury

tDCS/PPCS
Start date: October 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the early effects of transcranial direct current stimulation (tDCS) in patients with mild traumatic brain injury and persistent post concussion syndrome(PPCS) with cognitive deficits in long term episodic memory and executive function(inhibitory control).

NCT ID: NCT02255799 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Multicenter Evaluation of Memory Remediation After TBI With Donepezil

MEMRI-TBI-D
Start date: September 1, 2013
Phase: Phase 3
Study type: Interventional

This is a four-site, randomized, parallel design, double-blind, placebo-controlled, 10-week trial of donepezil 10 mg daily for verbal memory problems among adults with TBI in the subacute or chronic recovery period. The study will recruit 160 persons with TBI and functionally important memory problems during a four-year period of open recruitment. The study aims are: 1. To evaluate the effects of treatment with donepezil on verbal memory as assessed by the Hopkins Verbal Learning Test-Revised Total Trial 1-3; 2. To evaluate the effects of treatment with donepezil on memory-related activities as measured by the Everyday Memory Questionnaire; 3. To evaluate the effects of donepezil on attention, processing speed, neuropsychiatric symptoms, community participation, quality of life, and caregiver experiences.

NCT ID: NCT02240394 Active, not recruiting - Clinical trials for Traumatic Brain Injury

TCD Detection of Ophthalmic Artery Blood Flow Velocity Prediction Feasibility Study of Intracranial Pressure

Start date: March 2014
Phase: N/A
Study type: Observational

Increased intracranial pressure is a cause of disease progression in patients with brain disease, a common cause of poor prognosis. Intracranial pressure monitoring is the observation of the disease, treatment, evaluation and important way to improve the prognosis. Non-invasive intracranial pressure monitoring can be used to stroke, intracranial hemorrhage, brain trauma, encephalitis and other patients. Ophthalmic artery originated from the internal carotid artery, the optic canal into the orbit, the entire process can be divided into intracranial optic tube segment and orbital segment. investigators' preliminary experiments show that when intracranial pressure, intracranial ophthalmic artery segment velocity increases with increasing velocity difference orbital segment. Accordingly, the investigators speculate, may be judged by the level of intracranial pressure intracranial and orbital velocity difference between the ophthalmic artery segment, and accordingly calculate the specific values of intracranial pressure. The investigators will collect brain trauma surgery, performed invasive intracranial pressure monitoring cases, the use of transcranial Doppler ultrasound velocity and different segments of the ophthalmic artery pulsatility index, the invasive intracranial pressure and comparing the measured values to calculate the the critical value of the ophthalmic artery segment intraorbital and intracranial velocity difference when intracranial pressure, thus fitting Based on projections of mathematical formulas intracranial pressure. This study will provide a non-invasive intracranial pressure monitor new approach.

NCT ID: NCT02076373 Active, not recruiting - Clinical trials for Intraventricular Hemorrhage of Prematurity

Erythropoietin for the Repair of Cerebral Injury in Very Preterm Infants

EpoRepair
Start date: March 2014
Phase: Phase 3
Study type: Interventional

The purpose of this randomized and placebo-controlled EpoRepair trial is to evaluate the effect of intravenously administered recombinant human erythropoietin (Epo) as compared to placebo in preterm infants with brain damage on neurological development until five years od age.

NCT ID: NCT01990963 Active, not recruiting - Severe Brain Trauma Clinical Trials

Brain Densitometric Assessment With Axial Computerized Tomography After Severe Brain Trauma.

Start date: January 2010
Phase: N/A
Study type: Observational

Processing the Digital Imaging and COmmunications in Medicine (DICOM) of tomographic using Mannheim Lung Analyzing software (MALUNA®) , to obtain volumetrical and densitometric data of brain tissue after patients with severe brain trauma

NCT ID: NCT01882244 Active, not recruiting - Brain Injury Clinical Trials

Remotely Deployed TBI Study

RD
Start date: June 2013
Phase: N/A
Study type: Interventional

Injury to the brain can change the core of a person's being, affecting brain functions necessary to accomplish important goals in a complex world. Deficits in attention, working memory, and other aspects of goal-directed cognition affect a broad range of pursuits in everyday life, and are among the most prevalent and long-lasting consequences of brain injuries. The objective of this research is to develop remotely deployed training tools that target the most common, persistent and debilitating cognitive functions affected by traumatic brain injury (TBI); test the potential effects of the intervention and compare these effects to an active comparison intervention; and determine the neurocognitive and functional effects of computer-assisted remote training.

NCT ID: NCT01874847 Active, not recruiting - Clinical trials for Traumatic Brain Injury

PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin

PLAYGAME
Start date: September 2013
Phase: Phase 2/Phase 3
Study type: Interventional

PURPOSE: The long-term goal of this line of research is to develop rational, biologically based evidence for the treatment of post-concussion syndrome (PCS) in children. The objective of this application is to examine the effect of melatonin on the symptoms of PCS and its neurobiology using integrated neurodiagnostic techniques in children. OVERVIEW: PCS is a constellation of clinical symptoms including physical (i.e. headaches), cognitive (i.e. memory), and behavioral disturbances. PCS is associated with significant morbidity in the child and his/her family), and yet there are no evidence-based medical treatments available. This suggests an urgent need to develop novel treatment options to improve outcomes for children suffering from PCS. Melatonin has several relevant mechanisms of action, and neuroprotective effects. Recent research suggests that the explanations for persistent PCS symptoms may be due to alterations in neurotransmissions and neuronal circuitry, particularly involving the dorsolateral prefrontal cortex (DLPFC). Investigators have two specific aims: 1. To determine if treatment with melatonin improves PCS in children following mild traumatic brain injury. Hypothesis: treatment of mTBI children with PCS with 3mg or 10mg of oral melatonin for 28 days will result in a decrease in PCS symptoms as compared with placebo. Effects will be dose-dependent and may be independent of sleep effects. Methods: A randomized double blind, placebo controlled trial (RCT); Outcome measure is a PCS symptom questionnaire. A subsequent RCT will then be performed using the optimal melatonin dose at a second centre. 2. To understand the neurophysiological mechanisms of paediatric PCS and assess any resultant effects of treatment with melatonin. Methods: A case-controlled study within the RCT, using functional MRI and Transcranial Magnetic Stimulation to investigate the neurophysiological properties of paediatric mTBI before and after treatment; Treatment groups from the RCT will be compared with two control groups: i) normal controls and ii) asymptomatic mTBI children. SIGNIFICANCE: This study has the potential to 1) provide a safe and effective treatment for PCS and 2) will provide valuable information about the neurophysiological properties of the brain associated with PCS following mTBI in children and how these change with symptom resolution.