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Brain Injuries clinical trials

View clinical trials related to Brain Injuries.

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NCT ID: NCT01992055 Completed - Clinical trials for Acquired Brain Injury

Outcomes Following Neuropsychological Intervention in Acquired Brain Injury Outpatients With Executive Dysfunction

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

This Clinical Trial is a pilot study being conducted to study the impact of a specific cognitive rehabilitation program, Goal Management Training (GMT), in adult patients with executive dysfunction and associated problems in everyday functioning. The intervention program will also include relaxation training and psychoeducation regarding brain injury on everyday functioning, emotional status, and executive functioning. Goal Management Training focuses on teaching individuals strategies to compensate for executive functioning deficits and is based on a theory of goal neglect resulting in disorganized behavior following frontal lobe injury. It emphasizes strategies for self-monitoring and self-evaluation in everyday life. Given its goal-oriented emphasis, focus on individual everyday difficulties, and reports of improvements in self-reported executive failures and mood, GMT appears to be an ideal intervention treatment for individuals with executive and functional deficits. Given the emphasis of goal-oriented rehabilitation on reducing the impact of cognitive impairment on daily functioning, rather than attempting to restore cognitive abilities, a reduction in subjective reports of psychological distress is anticipated. This hypothesis is consistent with existing literature revealing reduced reports of annoyance and executive difficulties on self-report inventories. Improvements on tests of sustained attention and visuospatial problem-solving, as well as small effects on additional measures of planning, are also anticipated.

NCT ID: NCT01990768 Completed - Clinical trials for Traumatic Brain Injury

Prehospital Tranexamic Acid Use for Traumatic Brain Injury

TXA
Start date: May 2015
Phase: Phase 2
Study type: Interventional

Primary aim: To determine the efficacy of two dosing regimens of TXA initiated in the prehospital setting in patients with moderate to severe TBI (GCS score ≤12). Primary hypothesis: The null hypothesis is that random assignment to prehospital administration of TXA in patients with moderate to severe TBI will not change the proportion of patients with a favorable long-term neurologic outcome compared to random assignment to placebo, based on the GOS-E at 6 months. Secondary aims: To determine differences between TXA and placebo in the following outcomes for patients with moderate to severe TBI treated in the prehospital setting with 2 dosing regimens of TXA: - Clinical outcomes: ICH progression, Marshall and Rotterdam CT classification scores, DRS at discharge and 6 months, GOS-E at discharge, 28-day survival, frequency of neurosurgical interventions, and ventilator-free, ICU-free, and hospital-free days. - Safety outcomes: Development of seizures, cerebral ischemic events, myocardial infarction, deep venous thrombosis, and pulmonary thromboembolism. - Mechanistic outcomes: Alterations in fibrinolysis based on fibrinolytic pathway mediators and degree of clot lysis based on TEG. Inclusion: Blunt and penetrating traumatic mechanism consistent with TBI with prehospital GCS ≤ 12 prior to administration of sedative and/or paralytic agents, prehospital SBP ≥ 90 mmHg, prehospital intravenous (IV) access, age ≥ 15yrs (or weight ≥ 50kg if age is unknown), EMS transport destination based on standard local practices determined to be a participating trauma center. Exclusion: Prehospital GCS=3 with no reactive pupil, estimated time from injury to start of study drug bolus dose >2 hours, unknown time of injury, clinical suspicion by EMS of seizure activity, acute MI or stroke or known history, to the extent possible, of seizures, thromboembolic disorders or renal dialysis, CPR by EMS prior to randomization, burns > 20% TBSA, suspected or known prisoners, suspected or known pregnancy, prehospital TXA or other pro-coagulant drug given prior to randomization, subjects who have activated the "opt-out" process when required by the local regulatory board. A multi-center double-blind randomized controlled trial with 3 treatment arms: - Bolus/maintenance: 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours. - Bolus only: 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours. - Placebo: Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours.

NCT ID: NCT01986205 Completed - Clinical trials for Brain Injury, Chronic

Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury

HYBOBI2
Start date: September 6, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after brain injury. This study will enroll 90 individuals with persistent problems 6 months to 10 years after a brain injury. These individuals will be randomized to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive 40 daily hyperbaric chamber sessions. Participants will have a series of tests and questionnaires before they begin their chamber sessions, after they complete 40 sessions, and 6 months after they joined the study. These tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain imaging, a neurological examination, and an eye exam. Participants will also be asked to provide blood for future research. After the 6-month tests are complete, all participants will receive 40 hyperbaric oxygen sessions, then undergo the same tests at 9 months and 12 months.

NCT ID: NCT01975857 Completed - Clinical trials for Traumatic Brain Injury

Mind-Body Rehabilitative Program for Veterans With mTBI (Mild Traumatic Brain Injury)

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

The broad aim of the proposed study is to evaluate the comprehensive benefit of a novel mind-body therapeutic intervention, Mind-Body Bridging (MBB), in Veterans who suffer from mTBI and sleep disturbance co-morbid with PTSD and/or pain at the VA Salt Lake City Health Care System (VASLCHCS). Evidence for comprehensive benefit includes, but is not limited to, the average difference in outcomes between MBB and an active control, sleep education (SED), both integrated with the usual care for mTBI Veterans. The long-term goal of the proposed project is to introduce, implement and establish mind-body intervention programs as a behavioral health intervention modality that would serve as a generally sustainable health care intervention program before, during, and after deployment for military personnel.

NCT ID: NCT01965951 Completed - Stroke Clinical Trials

Remediation of Spatial Neglect Trial

RESPONSE
Start date: July 2013
Phase: N/A
Study type: Interventional

Problems with attention are a common and debilitating consequence of brain injury. Studies show that poor attention is the number one predictor of poor cognitive functioning one year post-injury. This is due to the fact that attention is a necessary component of more complex cognitive functions such as learning & memory, multi-tasking and problem solving. In many cases, individuals may exhibit problems with spatial attention known as 'hemi-spatial neglect syndrome' or simply 'neglect'. Many studies now show that the processing machinery of the brain is plastic and remodeled throughout life by learning and experience, enabling the strengthening of cognitive skills or abilities. Research has shown that brief, daily computerized cognitive training that is sufficiently challenging, goal-directed and adaptive enables intact brain structures to restore balance in attention and compensate for disruptions in cognitive functioning. The study aims to understand how our computer program can affect cognition and attention in those with acquired brain injury.

NCT ID: NCT01956136 Completed - Clinical trials for Traumatic Brain Injury (TBI)

Efficacy and Neural Basis of Music-based Neurological Rehabilitation for Traumatic Brain Injury

MUBI
Start date: March 2014
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) is one of the leading causes of serious, life-long disability among adolescents and young adults. Especially the cognitive, emotional, and motors deficits caused by TBI often impair everyday psychosocial functioning, quality of life and ability to work. The purpose of the study is to determine the long-term effect of music-based rehabilitation on cognitive, motor, emotional, and social recovery after TBI in adolescents and young adults, and to study the neural mechanisms that underlie behavioural recovery and the efficacy of music.

NCT ID: NCT01955785 Completed - Clinical trials for Traumatic Brain Injury

Respiratory Treatment of Patients With Moderate and Severe Traumatic Brain Injury

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

Intracranial pressure (ICP) in patients with traumatic brain injury (TBI) is influenced by several factors of which one is arterial CO2 tension. Patient with TBI are often sedated and mechanically ventilated in order to secure a stable PaCO2. This study compares two ventilation modus; Pressure Controlled Ventilation (PC) and Pressure Regulated Volume Controlled ventilation (PRVC) in order to observe which of the two ventilation strategies results in a more stable ICP and arterial CO2 pressure (PaCO2).

NCT ID: NCT01952288 Completed - Clinical trials for TBI-Traumatic Brain Injury

Simvastatin for mTBI

Start date: September 16, 2013
Phase: Phase 4
Study type: Interventional

Study of simvastatin in Iraq/Afghanistan Veterans with multiple blast exposure and mTBI. The study will measure substances in cerebrospinal fluid (CSF) that are related to dementing disorders.

NCT ID: NCT01948947 Completed - Clinical trials for TBI (Traumatic Brain Injury)

Improving Functions in MTBI Patients With Headache by rTMS

Start date: May 2014
Phase: N/A
Study type: Interventional

Due to recent wars in Afghanistan and Iraq, the number of Veteran suffering from Mild traumatic brain(MTBI) injury and PTSD increases rapidly. Headache is one of the most debilitating clinical symptoms in Veteran with MTBI and the cause of it is still not entirely clear. Recently, the use of non-invasive brain stimulation such as repetitive transcranial magnetic stimulation(rTMS) has yielded favorable clinical outcome in a few intractable chronic central pain conditions including headaches. This study aims to 1) assess the effect of rTMS in relieving headache and improving neurophysiological functions; and 2)explore the neuronal mechanisms associated with MTBI related headache and the analgesic effect of rTMS with function magnetic resonance imaging (fMRI).

NCT ID: NCT01948505 Completed - Clinical trials for Endovascular Patients Undergoing Intracranial Intervention

Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit

Start date: August 2013
Phase: Phase 4
Study type: Interventional

To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain. To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients. To assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.