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Traumatic Brain Injury clinical trials

View clinical trials related to Traumatic Brain Injury.

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NCT ID: NCT02938130 Recruiting - Cerebral Palsy Clinical Trials

The Impact of Community-based Wellness Programs on The Triple Aim

Start date: October 2016
Phase: N/A
Study type: Interventional

People with disabilities experience a staggering incidence of secondary conditions that can result in death or negatively impact their health, participation in the community, and quality of life. Many of these chronic secondary conditions are preventable. The Institute for Healthcare Improvement has advocated for optimizing care through programs that simultaneously improve health and the patient experience of care, while reducing cost, called the "Triple Aim." Studies have shown that the Triple Aim can be achieved through programs that facilitate community integration; however the U.S. healthcare system lacks a paradigm of care for individuals with disabilities that promotes community integration. In order to identify potential models of healthcare delivery for individuals with disabilities that are effective in achieving the Triple Aim, we will conduct a rigorous research project to evaluate the impact of two different models of care on the Triple Aim: 1) a community-based care management program delivered by a non-profit organization through waiver funds, and 2) the Program for All-inclusive Care for the Elderly (PACE) applied to younger individuals with disabilities between ages 55-64.

NCT ID: NCT02931474 Withdrawn - Clinical trials for Traumatic Brain Injury

Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia

Start date: October 6, 2016
Phase: Phase 2
Study type: Interventional

Background: People who have had a traumatic brain injury (TBI) often have trouble sleeping. TBI may also alter hormones, which can cause poor sleep. Researchers believe that a form of growth hormone releasing hormone (GHRH) might improve sleep in service members and veterans who have had a TBI. Objective: To see if GHRH can improve sleep in people who have had a TBI. Eligibility: Active duty service members or veterans (active duty in the past 10 years) ages 18-45 who have had a TBI in the past 6 months to 10 years. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Getting ACTH (a hormone) through an intravenous catheter (thin plastic tube) Interview about their mood and alcohol and drug use Questionnaires about their TBI, mood, and sleep Participants will have 2 overnight study visits a couple weeks apart. These will include: Physical exam Urine sample Two intravenous catheters placed. Blood samples will be taken throughout the night. Two shots under the skin of the belly. The shots will be GHRH on one visit and placebo on the other. Spending the night in the sleep lab. Their brain waves will be recorded with electrodes placed on the scalp. A questionnaire in the morning about their sleep Participants will be called a few days after each overnight visit. They will be asked about how they are feeling and to rate their sleep.

NCT ID: NCT02911675 Withdrawn - Clinical trials for Traumatic Brain Injury

Assessing the Accuracy and the Impact of Standard-practice Ventricular Drainage on Intracranial Pressure Measurements Following Traumatic Brain Injury

Dual ICP
Start date: December 1, 2018
Phase:
Study type: Observational [Patient Registry]

Traumatic brain injury (TBI) is a leading cause of death following injury in civilian populations and is a major cause of death and disability in combat casualties. While primary brain injury cannot be reversed, the management of severe TBI focuses on the mitigation of secondary injury mechanisms which occur as part of the downstream effects of the primary damage to the brain. Many secondary injury mechanisms are manifested clinically as elevated intracranial pressure (ICP) and cerebral perfusion pressure (CCP). This level and duration of elevated ICP is strongly associated with poor long term patient outcome. Currently, there are two invasive techniques that are used at our facility for monitoring ICP and CPP. The first method requires the placement of an intra-parenchymal fiberoptic pressure monitor (IPM), also known as a camino, into the brain tissue that measures and displays ICP continuously. The second method requires placement of an extracranial ventricular drain (EVD) which both measures ICP when it is closed or clamped and also allows for therapeutic drainage of cerebral spinal fluid (CFS) to reduce pressure within the skull when it is open. While clinical practices vary greatly across institutions, current clinical practice at our institution when using the EVD for ICP management is to allow continuous therapeutic CSF drainage and to manually close the drain for ICP assessment on an hourly basis. However, in a retrospective of study of TBI patients at our institution with simultaneous IPM and EVD placement, a spike in ICP was noted to correspond with the clamping of the EVD which often remained elevated for 15-30 minutes before returning to baseline. Due to the strong association between poor patient outcome and elevated ICP, this finding is alarming. These findings have important implications for procedures to not only treat elevated ICP, but also prevent potentially harmful intermittent elevations in ICP. Therefore, this study seeks to prospectively investigate the association between EVD clamping and elevated ICP. Specifically, this study has 2 main objectives: 1. Evaluate the need for an optimized device that can simultaneously measure intracranial pressure and drain CSF without requiring potentially harmful clamping. 2. Provide data in support of retaining or modifying current clinical practices regarding intermittent versus continuous monitoring during periods of therapeutic drainage of CSF.

NCT ID: NCT02901262 Completed - Clinical trials for Traumatic Brain Injury

Continuous Quantified EEG in NeuroIntensive Care

CrazyEEG
Start date: January 2016
Phase:
Study type: Observational [Patient Registry]

To evaluate the ability of NICU (NeuroIntensive Care Unit) staff to interpret, before and after a training period, symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG (continuous electroencephalography/quantitative electroencephalography) tracings.

NCT ID: NCT02899468 Completed - Clinical trials for Traumatic Brain Injury

Evaluation of a Novel Integrative and Intensive Virtual Rehabilitation Program for Service Members Post TBI

Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the feasibility and effectiveness of a novel virtual reality (VR) therapeutic rehabilitative device (BrightBrainerTM) to treat patients with traumatic brain injury (TBI). These patients, service members with TBI, can be both with and without upper limb dysfunction and use uni- and bimanual virtual reality (VR) exercises to improve cognitive and motor function, as well as mood.

NCT ID: NCT02891941 Terminated - Clinical trials for Traumatic Brain Injury

Neuroimaging & Plasma Markers for Predicting Outcomes After Mild Traumatic Brain Injury

Start date: June 2013
Phase: N/A
Study type: Observational [Patient Registry]

This exploratory study aims to identify the most promising biomarkers that alone or in combination might predict development of mood disorders [i.e., major depression (MD], cognitive disorders [i.e., executive function deficits (EFD)], and functional impairment following repetitive/mild traumatic brain injury (MTBI).

NCT ID: NCT02891421 Completed - Clinical trials for Traumatic Brain Injury

Therapeutic Horsemanship in Veterans

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

The project partnered with U.S. military veterans with a premier accredited therapeutic riding center for six weeks. The veterans interacted with horses by grooming and learning about them, as well as riding them for one hour per week during which they gained a variety of skills. We hoped the veterans would experience a reduction in Post Traumatic Stress Disorder (PTSD) symptoms, depression, and loneliness, while improving their social and emotional health and self-efficacy.

NCT ID: NCT02889289 Completed - Clinical trials for Traumatic Brain Injury

Using the Xbox Kinect for Chronic TBI

Start date: May 2015
Phase: N/A
Study type: Interventional

This study will evaluate the potential for improving balance for a single individual with a history of traumatic brain injury (TBI). The participant will engage in supervised therapy using commercial games on the Xbox Kinect. This study will also evaluate the viability of improving cardiovascular fitness using this intervention as well. The investigators hypothesize that balance improvements will occur and that using the Xbox Kinect is a viable way of improving cardiovascular fitness.

NCT ID: NCT02867137 Completed - Clinical trials for Traumatic Brain Injury

Biomarkers in Prehospital Rule-out of Intracranial Lesions in TBI Patients

PreTBI I
Start date: February 15, 2017
Phase:
Study type: Observational

The PreTBI I study will investigate whether prehospital blood samples drawn already in the ambulance can rule-out intracranial lesions in patients suffering head trauma. The study aims to improve triage and treatment of patients suffering mild head trauma, who are considered low-risk patients. These patients do not always benefit from hospitalization, but are nevertheless admitted on precaution, as clinical assesment can be difficult. Hypotheses: 1. A prehospital measurement of serum S100B ≤ 0,10 microgram/L in mild TBI patients rules out traumatic intracranial lesion with a sensitivity >97%. 2. A prehospital measurement of serum GFAP (glial acidic fibrillary protein) in mild TBI patients rules out traumatic intracranial lesion with sensitivity >97% and results in lower false positive rate than S100B. 3. Prehospital measurements of both GFAP and S100B results in lower false positive rates than in-hospital measurements.

NCT ID: NCT02861547 Recruiting - Clinical trials for Traumatic Brain Injury

Development and Validation of a Prognostic Score for Early Death in Head Injury Patients.

SCORE TC
Start date: May 2015
Phase: N/A
Study type: Observational

Traumatic brain injury (TBI) is a serious condition with high morbidity and mortality. The Glasgow score alone, assessed at the initial phase, is not enough to determine the prognosis. The aim of this study is to define and to evaluate a prognostic score for early death based on clinical and CT-scan findings in an observational retrospective derivation cohort of patients hospitalized for traumatic brain injury. This cohort will allow us to carry out a uni- and then multi-variate analysis so as to create a prognostic score for early death. We will subsequently test this score in a prospective validation cohort.