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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT01691378 Completed - Clinical trials for Traumatic Brain Injury

Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury

WtoH
Start date: January 2012
Phase: N/A
Study type: Interventional

The purpose of this project is to provide further evidence regarding a groundbreaking psychological treatment for suicide prevention in individuals with moderate to severe traumatic brain injury (TBI), Window to Hope (WtoH). The study will be one of the first five randomized clinical trials (RCTs) internationally to evaluate a psychological treatment for affective distress after TBI and the first conducted in the United States (U.S.) to specifically address suicide risk as an outcome. The current project aims to adapt WtoH for U.S. military personnel/Veterans (expert Consensus Conference, participant total up to 15), implement the intervention in a Veterans Affairs Medical Center (VAMC) (Pilot Groups 1-4, participant total up to 12), and replicate the results from the original trial in this novel context with a larger sample size (n=70 completed protocols [up to 90 recruited]. Deliverables are expected to include an intervention suitable for both dissemination and larger Phase III trials.

NCT ID: NCT01688869 Completed - Clinical trials for Brain Injury, Traumatic

Mild Traumatic Brain Injury Registry

mTBI
Start date: April 2012
Phase:
Study type: Observational

The purpose of the study is to gather information about patients with mild traumatic brain injury in order to develop guidelines for evaluation and treatment.

NCT ID: NCT01687153 Completed - Clinical trials for Mild Cognitive Impairment

A Study of Brain Aging in Vietnam War Veterans

DOD-ADNI
Start date: October 2012
Phase:
Study type: Observational

Traumatic brain injury (TBI) and post traumatic stress disorder (PTSD) are common combat related problems and may be associated with a greater risk of Alzheimer's disease (AD). The purpose of this study is to examine the possible connections between TBI and PTSD, and the signs and symptoms of AD on Veterans as they age. The information collected will help to learn more about how these injuries may affect Veterans of the Vietnam War as they grow older, as well as Veterans of the current wars in Iraq and Afghanistan, who also have these types of combat related injuries.

NCT ID: NCT01681589 Completed - Clinical trials for Traumatic Brain Injury

Relationship Between Attention and Emotional Regulation Post-Traumatic Brain Injury (TBI)

Start date: August 2012
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to investigate the relationship between attention and emotional function post-Traumatic Brain Injury (TBI) in an effort to better understand the cognitive mechanisms of emotional processing in patients with TBI, and explore novel treatment strategies to improve emotional regulation using with transcranial direct current stimulation (tDCS) to modulate activity in the dysfunctional prefrontal-limbic circuits.

NCT ID: NCT01670526 Completed - Clinical trials for Traumatic Brain Injury

Rivastigmine Patch in Veterans With Cognitive Impairment Following TBI

RIVET
Start date: December 2012
Phase: Phase 3
Study type: Interventional

Difficulties with intellectual functioning, particularly memory functions, are common and source of long-term disability after Traumatic Brain Injury (TBI). However, there is very little information about pharmacologic (i.e., medication) treatments targeting these deficits. There are growing data showing brain abnormalities in acetylcholine, the chemical system that manages memory, in TBI. These findings provide the rationale for the use of cholinesterase inhibitors, medications that modulate this system, in TBI patients. As the prevalence of TBI among Veterans of recent military conflicts increases, becoming a "signature injury" of the Iraq and Afghanistan conflicts, it is of utmost importance to the Veterans Health Administration to collect scientific data on the efficacy of pharmacological treatments for intellectual difficulties in TBI patients. This study will evaluate the effects of the cholinesterase inhibitor rivastigmine transdermal patch in Veterans with TBI and posttraumatic memory problems. Results will provide much needed data that will help treat Veterans with TBI.

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: 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