View clinical trials related to Brain Injuries, Traumatic.
Filter by:This project addresses the rehabilitation and mental health needs of married combat Veterans post-deployed from Iraq or Afghanistan with a mild traumatic brain injury (mTBI) and/or significant posttraumatic stress (PTS) or combat-related stress (CS) by providing psychoeducation, communication and problem solving skills in a multifamily group (MFG) setting. In this group, Veterans and spouses/cohabiting partners learn customized therapeutic strategies to help compensate for deficits and promote Veteran community integration, interpersonal and emotion regulation skills, and marital satisfaction. The effectiveness of the skills-based MFG will be compared to that of a health education group which offers a supportive environment and basic education without skills training through a randomized clinical trial. As there is currently no family-based intervention for Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans with mTBI offered within the VA spectrum of services, this intervention fills a crucial gap in healthcare for our newest Veterans.
The purpose of this study is to examine the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) combined with Amantadine relative to rTMS Alone and Amantadine Alone for persons in chronic states of seriously impaired consciousness. The hypothesis is that provision of rTMS+Amantadine will provide a safe yet synergistic effect that induces or accelerates functional recovery.
The purpose of this research study is to investigate the effectiveness of a technique designed to improve processing speed (i.e. the amount of time it takes to process information) in a Traumatic Brain Injury (TBI) population. The study is designed to study how well this technique can help people with TBI increase their processing speed and their ability to function better in everyday life.
Background: A traumatic brain injury (TBI) could mean a person is at high risk for other long-lasting problems. These problems could include post-traumatic stress disorder (PTSD), depression, and post-concussive syndrome (PCS). For example, about 700,000 Americans each year who have a TBI later go on to have PTSD also. Depression and PCS are also common in people who had a TBI. Some people will have these problems later. These problems can seriously interfere with a person s life. Some people will not have these problems at all. There are many reasons for this difference. Researchers think the main reason is that people have different genetic and environmental influences. Right now, we only have few kinds of treatments to prevent or treat these problems after a TBI. The few treatments we have often do not work well. It is important to understand what factors make a person at high risk for these problems after a TBI. This could allow researchers and doctors to help address these problems early. Addressing these problems earlier may help a person have better health in the long run. Objectives: - To study the biological changes that happen after mild to moderate TBI which could be linked to the onset of PTSD, depression, and post-concussive syndrome - To study brain mechanisms that could explain risks for getting a psychiatric disorder after mild to moderate TBI. This will be done using a test called functional MRI (fMRI). This test takes images of the brain while a person is doing a simple task. Eligibility: - Men and women who are 18 to 65 years old. - Had a mild to moderate TBI (including concussion) in the last month. Design: - 5 outpatient visits to the NIH Clinical Center over one year. - The first visit is a screening visit to see if you can join the study. This visit must happen within 30 days of the TBI. The visit includes lab work (blood and urine), a history and physical exam done by a physician or nurse practitioner, and a psychiatric interview with a behavioral health nurse. - Visits 2, 3, 4 and 5 happen at one, three, six and twelve months post-injury. At these visits participants may have some or all of the following tests: blood and saliva collection, urine collection, questionnaires and interviews to assess symptoms, a test to see your response to stress (called hydrocortisone challenge), and fMRI brain imaging. - This study does not provide treatment. - This study is not a substitute for seeing a primary care provider. - This study should not replace any therapies you may be taking.
CREACTIVE is a large-scale observational cohort study concerning Traumatic Brain Injury (TBI) care in the ICU setting
This project was designed to determine brain imaging patterns using 2-(1-{6-[(2-fluorine 18-labeled fluoroethyl)methylamino]-2-naphthyl}ethylidene)malononitrile ([F-18]FDDNP) with positron emission tomography (PET) in participants with suspected Chronic Traumatic Encephalopathy (CTE), a progressive degenerative disease of the brain found in people with a history of repetitive traumatic brain injuries (TBIs), characterized by personality, behavioral, and mood disturbances, cognitive impairment, and sometimes motor symptoms. Currently, CTE can only be definitely diagnosed from neuropathological examination of the brain after autopsy. Developing tools to assist in the detection of this condition in living individuals at risk would facilitate research focusing on discovering potential prevention and treatment strategies.
The purpose of this research study is to investigate different types of task training to determine if training improves thinking processes following traumatic brain injury.
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.
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.
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.