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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT01640158 Completed - Clinical trials for Traumatic Brain Injury

Broad-spectrum Cognitive Remediation: Effects of a Brain Plasticity-based Program in Mild Traumatic Brain Injury

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

The primary objective of this study is to evaluate the effects of plasticity-based, adaptive cognitive remediation on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with persistent post-concussive symptoms (PPCS) following a mild traumatic brain injury (mTBI, also referred to as a concussion, or blast exposure), as compared to a computer-based control.

NCT ID: NCT01633268 Recruiting - Clinical trials for Traumatic Brain Injury

Estimating Brain Biomechanics Using MRI

Start date: July 4, 2012
Phase:
Study type: Observational

Objective: In this study we will develop and apply imaging techniques to perform the first three-dimensional (3-D) measurements of brain biomechanics during mild head movement in healthy human subjects. Biomechanics is the application of mechanics, or the physical principles in action when force is applied to an object, to the anatomical structure and/or function of organisms. Such techniques will be invaluable for building computational models of brain biomechanics, understanding variability of brain biomechanics across individual characteristics, such as age and sex, and determining brain sub-structures at risk for damage when movement of the head is accelerated, such as during a traumatic event. Study Population: Measurements will be performed on 90 healthy men and women aged 18-65. Design: We will build upon the model pioneered by our collaborator, Dr. Philip Bayly. The model places a human subject in a magnetic resonance (MR) scanner with one of two head support units that allows a specific range of motion. Each head support is latched such that it can be released by the subject, and results in either a rotation of the head of approximately 30 degrees or a flexion-extension of the head of approximately 4 degrees. Although both supports are weighted so that the motion is repeatable if the subject is relaxed, the subject can easily counteract the weight. The resulting acceleration/deceleration is small (in the range of normal activities, such as turning one's head during swimming) and has been validated and used in other human investigations of brain biomechanics. The subject repeats the motion multiple times during the MR scan under their own volition and desired pace to measure motion of the head and brain. Outcome measures: This project is a pilot study evaluating the potential of extracting three-dimensional estimates of brain deformation, such as strain measurements, using MR imaging. A primary outcome of this project will be a fast MR acquisition sequence for measuring 3-D brain deformation. The sequence will be evaluated by applying the protocol to human subjects, followed by preliminary quantification of the reproducibility and stability of deformation measurements.

NCT ID: NCT01625962 Completed - PTSD Clinical Trials

Brain Indices of Risk for Posttraumatic Stress Disorder (PTSD) After Mild Traumatic Brain Injury (mTBI)

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

This is a prospective, longitudinal cohort study to evaluate the associations between indices of brain structure and function (measured at baseline, as soon as possible after injury) and course of post-traumatic stress disorder (PTSD) symptoms. Subjects will be service members who have sustained mild traumatic brain injury (classified as either "impact-induced mTBI" or "blast-induced mTBI"; n = 100 completers) or an extracranial injury (ECI) with no evidence of traumatic brain injury (TBI) (n = 100 completers). Subjects will complete an assessment battery at baseline and 6 months later that includes (1) structural magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) derived from a 3-Tesla magnet; (2) event-related brain potentials (ERPs) derived from brain electrical activity; (3) neurocognitive tests; and (4) neurological soft signs (NSS). Specific indices of brain structure and function derived from these assessments are hypothesized to demonstrate a significant relationship with course of PTSD symptoms, which will be measured at baseline, 3 months, and 6 months.

NCT ID: NCT01625416 Completed - Depression Clinical Trials

Trauma Survivors Outcomes and Support Study IV

TSOS IV
Start date: July 2012
Phase: N/A
Study type: Interventional

After traumatic injuries some people have difficulty returning to the routine of their everyday activities and may experience physical and emotional pain. The purpose of this study is to identify new ways of providing support for physically injured trauma survivors. All study procedures are designed to work around patient needs and be as flexible as possible in order to best fit into patients' post-injury recovery. Patients who are eligible for the study are randomly assigned to receive care as usual, or the "new method of treatment," with the study Trauma Support Specialist (TSS). This TSS will be in contact with the patient for the next three months; they may visit the patient at the hospital or at outpatient medical appointments. The TSS will also be available to talk with the patient over the telephone. Overall, the TSS will be working with the patient to help with difficulties returning to his or her routine and overcoming physical and emotional pain experienced after the injury. We believe that patients who receive the "new method of treatment," will be more able to return to daily routines and/or cope with the emotional stress that can occur after an injury. Intervention technology innovations including mHealth applications and web-based links will be included in the investigation.

NCT ID: NCT01618786 Completed - Clinical trials for Traumatic Brain Injury

Flooring for Injury Prevention Trial

FLIP
Start date: September 1, 2013
Phase: N/A
Study type: Interventional

This study will evaluate the efficacy of novel compliant flooring in reducing injuries due to falls in a long-term care facility, determine the cost effectiveness of this intervention, and assess perceptions about compliant flooring among staff, residents, and families. The investigators hypothesize that compliant flooring will (1) reduce the incidence of injuries due to falls in long-term care residents; (2) represent an overall cost-savings when material and implementation costs are considered relative to direct and indirect costs associated with injuries due to falls; and (3) be received positively by staff, residents, and their family members.

NCT ID: NCT01611194 Completed - Clinical trials for Post-Concussion Syndrome

mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms

BIMA
Start date: September 11, 2012
Phase: Phase 2
Study type: Interventional

Purpose of this study is to investigate the mechanisms of action of hyperbaric oxygen therapy for persistent post-concussive symptoms after mild tramatic brain injury

NCT ID: NCT01606111 Terminated - Clinical trials for Traumatic Brain Injury

The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery

CAPTAIN
Start date: September 2013
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to investigate safety and efficacy of Cerebrolysin as add-on therapy to standard care in patients with acute traumatic brain injury (TBI). The study duration for each patient is 180 days.

NCT ID: NCT01596569 Completed - Clinical trials for Traumatic Brain Injury

Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury

COST-TBI
Start date: May 2012
Phase: N/A
Study type: Interventional

This study investigates the efficacy of a novel neurorehabilitation program combining noninvasive brain stimulation (transcranial magnetic stimulation or TMS) and cognitive therapy, on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).

NCT ID: NCT01589172 Completed - Clinical trials for Traumatic Brain Injury

Evaluating the Use of Thromboelastography to Diagnose Coagulopathy After Traumatic Brain Injury

Start date: May 1, 2012
Phase:
Study type: Observational

The investigators will obtain thromboelastography (TEG) on pediatric patients admitted to the Rady Children's Hospital ICU after traumatic brain injury on admission to our ICU and after 24 hours of care. The investigators hypothesize that TEG will identify abnormalities of coagulation that are not identified by traditional coagulation studies, i.e. prothrombin time (PT), activated partial thromboplastin time (aPTT), and international normalized ratio (INR).

NCT ID: NCT01588691 Completed - Clinical trials for Traumatic Brain Injury

Traumatic Brain Injury Peripheral Nerve Study

TBI
Start date: December 2011
Phase: Phase 1
Study type: Interventional

Peripheral nerve stimulation for the treatment of sequelae due to traumatic brain injury. This study will specifically examine patients with mild traumatic brain injury (TBI) who have persistent cognitive impairments lasting one year or longer. Neuropsychological testing will occur to confirm the diagnosis.