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Traumatic Brain Injury clinical trials

View clinical trials related to Traumatic Brain Injury.

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NCT ID: NCT04602806 Completed - Clinical trials for Traumatic Brain Injury

Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) Precision Medicine Phase 2 Option 1

Start date: June 1, 2021
Phase:
Study type: Observational

This study is being conducted to validate early and ultra-early blood-based and novel imaging biomarkers of Diffuse Axonal Injury (DAI), Microvascular Injury (MVI), and neuroinflammation that may serve as predictive and pharmacodynamic biomarkers in a new cohort of moderate-severe TRACK-TBI subjects. The study team will enroll a cohort of moderate to severe TBI subjects (N=50), stratified according to VA/DoD criteria for these injury severities through the existing TRACK-TBI network sites to obtain novel advanced neuroimaging and more frequent biomarker sampling. Subjects will be assessed over 3 months.

NCT ID: NCT04558346 Completed - Clinical trials for Traumatic Brain Injury

Ghrelin (OXE--103) for Acute Concussion Management

Start date: October 20, 2020
Phase: Phase 2
Study type: Interventional

Concussions are the leading form of mild traumatic brain injury. Management of concussions and mild traumatic brain injury is a high priority medical focus, social concern, and research topic. Currently, there are no FDA approved treatments for acute concussion. The current standard of care is rest followed by gradual return to normal activity. The purpose of this study is to show improvement in the way patients feel or function after a concussion. OXE-103 is a protein hormone produced in the laboratory which identical to the hormone ghrelin that is secreted by the stomach. This study will investigate the use of this hormone as treatment for symptoms of acute concussion. The goal of this study is to show improvement in the way study participants feel or function after concussion. An OXE-103 (ghrelin) agonist is already FDA approved for another condition, but not for concussion. For concussion, it is considered investigational. This study will examine, if ghrelin is taken every day for two weeks, if the brain will heal faster and help improve or resolve symptoms. The study will also include a placebo arm and a non-treatment group (for those who wish to participate but do not want to receive any treatment). The OXE-103 and placebo will be self-administered through injections using needles.

NCT ID: NCT04554537 Completed - Clinical trials for Traumatic Brain Injury

Strategic Memory and Reasoning Training for Cognitive Problems

SMART
Start date: May 2016
Phase: N/A
Study type: Interventional

The focus of this study is to test a treatment program (Strategic Memory Advanced Reasoning Training; SMART) that was developed to address specific brain functions found to be crucial for the recovery following traumatic brain injury (TBI). New research has shown that when these very specific brain functions are targeted, such as ability to focus on a task while ignoring irrelevant information, brain changes are more significant. SMART emphasizes top-down processing by targeting focused attention, assimilation of information, and mental flexibility and innovation, all higher-order cognitive functions driven by the frontal lobes. Evidence from other top-down cognitive training programs demonstrates their effectiveness in improving cognitive and daily functioning in individuals reporting a TBI. In addition to improving frontal lobe capacity, SMART has also been shown to increase brain blood flow critical for complex thinking and strengthen white matter integrity. The effectiveness of SMART has been extensively tested with a variety of populations, including healthy adults and adolescents, adolescents with brain injuries, healthy seniors and those at risk for Alzheimers, and veterans and civilians with lingering impairment following TBIs. This will be the first study to test its effectiveness with individuals with mild TBI (MTBI) and posttraumatic stress disorder (PTSD). The SMART program has previously been tested with patients with TBI using an 18-hour training format. When compared to the Brain Health Workshop (BHW), an education-based active learning module, participants in the SMART group (n = 31) demonstrated improvements in gist reasoning, executive function, and memory, generalization of improvement to daily functioning activities and continuation of these gains 6 months posttraining. The training consisted of 15 hours of training conducted over 10 group sessions in the first 5 weeks and a final 3 hours of training at spaced intervals over the next 3 weeks. SMART training has not been tested with patients with PTSD-related neuropsychological impairments. The purpose of the current study is to investigate the efficacy of a shortened training program (9 hours) in improving neurocognitive function in patients with mTBI and/or PTSD.

NCT ID: NCT04553848 Completed - Clinical trials for Traumatic Brain Injury

Augmented Reality and Treadmill Training After Traumatic Brain Injury

Start date: October 19, 2020
Phase: N/A
Study type: Interventional

Up to 40 participants will be enrolled in this study in order to obtain complete data on 30 participants. The investigators will be assessing if Augmented reality in combination with treadmill training is safe and feasible to use in the clinical environment with participants who have chronic TBI and if there is a signal of effect that this intervention may be more beneficial than treadmill training alone or standard of care.

NCT ID: NCT04548180 Completed - Clinical trials for Traumatic Brain Injury

Genome-Wide Assocation Study in Patients With Brain Injury Associated Fatigue and Altered Cognition (BIAFAC)

Start date: June 21, 2021
Phase:
Study type: Observational

The aim of this study is elucidate genetic susceptibility of patients with traumatic brain injury (TBI) and symptoms of Brain Injury Associated Fatigue and Altered Cognition (BIAFAC) using genome-wide association study (GWAS).

NCT ID: NCT04497155 Completed - Clinical trials for Traumatic Brain Injury

Prehospital Norepinephrine and Early Mortality in Traumatic Shock

Start date: January 1, 2013
Phase:
Study type: Observational

The effect of early, prehospital norepinephrine use in patients with traumatic shock on mortality is unknown. Recent existing observational evidence from single system data (US, France, Japan) are conflicting. The investigators hypothesize that prehospital norepinephrine is associated with decreased mortality when used in patients with traumatic shock.

NCT ID: NCT04496076 Completed - Clinical trials for Traumatic Brain Injury

COVID-19 Brain Injury

Start date: April 2, 2020
Phase:
Study type: Observational

A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.

NCT ID: NCT04485494 Completed - Clinical trials for Traumatic Brain Injury

Blood-based Biomarkers for the Prognosis of Sports Related Concussion

Start date: July 1, 2018
Phase:
Study type: Observational

The diagnosis of sports related concussion still relies heavily on a subjective assessment. In this study the investigators want to assess the prognostic value of blood-based biomarkers with recovery from concussive episodes over specific time points post-injury. Our research aims to (1) assess that the World Rugby's head injury assessment (HIA) can identify that a concussion has taken place by measuring specific biomarkers in the blood and (2) to track these biomarkers over time post-injury as a means to assess player health.

NCT ID: NCT04465019 Completed - Clinical trials for Traumatic Brain Injury

Exoskeleton Rehabilitation on TBI

Ekso-TBI
Start date: September 25, 2019
Phase:
Study type: Observational

Background: Traumatic brain injury (TBI) is one of the leading causes of disability in the United States. The EKSO GT Bionics® (EKSO®) is a robotic exoskeleton approved by the Federal Drug Administration (FDA) for rehabilitation following a cerebrovascular accident (CVA or stroke) and recently received approval for use in patients with TBI. The aim of the study was to examine if the use of exoskeleton rehabilitation in patients with TBI will produce beneficial outcomes. Methods: This retrospective chart-review reports the use of the (EKSO®) robotic device in the rehabilitation of patients with TBI compared to patients with CVA. The investigators utilized data from a single, private rehabilitation hospital for patients that received post-CVA or post-TBI robotic exoskeleton intervention. All patients that used the exoskeleton were discharged from the hospital between 01/01/2017 to 04/30/2020. Ninety-four percent (94%) of patients in the CVA groups and 100% of patients in the TBI group were of Hispanic or Latino ethnicity. Gains in total Functional Independence Measure (FIM), walking and cognition, and length of stay in the rehabilitation facility were measured. Results: Patients in the TBI group (n=11) were significantly younger than the patients in the CVA group (n=66; p< 0.05). Both groups spent a similar amount of time active, number of steps taken, and the number of sessions in the exoskeleton. Both groups also started with similar admission FIM scores. The FIM gain in the TBI group was similar to that of the CVA group (37.5 and 32.0 respectively). The length of stay between groups was not different either. Conclusions: The use of exoskeleton rehabilitation in patients with TBI appear to produce similar outcomes as for patients with CVA, prompting further attention of this intervention for this type of injury.

NCT ID: NCT04428970 Completed - Clinical trials for Traumatic Brain Injury

Intracranial Pressure (ICP) Monitoring Following Traumatic Brain Injury (TBI)

Start date: January 1, 2007
Phase:
Study type: Observational

The aim of this retrospective cohort study is to evaluate complications rates, indications, and the utility of follow-up imaging studies of ICP measurement in severe TBI patients.