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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT03054285 Recruiting - Clinical trials for Traumatic Brain Injury

Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?

Start date: July 1, 2017
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to prospectively assess in randomized fashion whether short term anti-seizure prophylaxis in traumatic brain injured patients decreases the incidence of seizures in the early post-injury period. A secondary objective is to evaluate whether there are differences in mortality, hospital length of stay, functional outcome at hospital discharge, hospital cost, discharge status (home, rehabilitation facility, etc.) for patients who receive and do not receive anti-seizure prophylaxis.

NCT ID: NCT03034031 Recruiting - Clinical trials for TBI (Traumatic Brain Injury)

MR Imaging Study of TBI in Children

MISTIC
Start date: June 24, 2018
Phase:
Study type: Observational

This project will combine the data collected from structural and functional MRI scans and neuropsychology performance post-TBI in children. Patients will be followed for a year, in order to examine the brain and cognitive recovery post head injury.

NCT ID: NCT02993549 Recruiting - Clinical trials for Traumatic Brain INjury

TBI Multimodal Monitoring Study

monTBI
Start date: September 16, 2017
Phase:
Study type: Observational

Head injury is a common and devastating condition that can affect people at any stage of their lives. The treatment of severe head injury takes place in intensive care where interventions are designed to protect the brain from further injury and provide the best environment for recovery. A number of different monitors are used after head injury, including a monitor called microdialysis, to measure how the brain is generating energy. Abnormalities in these monitors guide doctors to the right treatments when the brain is at risk of further injury. There are lots of ways that the brain can be injured further after head injury such as raised pressure in the skull from brain swelling, low oxygen levels and low glucose levels. In this study we aim to combine information from all of these monitors to figure out what the underlying problem is and choose the right intervention to treat the problem that is affecting the patient at the time and compare this with previous treatment protocols to see if it improved outcome. Aim: To establish and validate a protocol to treat abnormalities in a microdialysis measure called lactate/pyruvate ratio (LPR) that reflects how cells are generating energy, and compare it with patient cohorts not being monitored using the current protocol.

NCT ID: NCT02990793 Recruiting - Clinical trials for Traumatic Brain Injury

Clinical Trial to Evaluate the Safety and Efficacy of MeRT Treatment in Post-Traumatic Stress Disorder

MeRT-005-B
Start date: April 4, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of individualized, Biometrics-guided Magnetic e-Resonance Therapy (MeRT) treatment of Post-Traumatic Stress Disorder

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: NCT02920788 Recruiting - Clinical trials for Brain Injuries, Traumatic

Mild TBI Assessment & Rehabilitation

MTAR
Start date: March 9, 2017
Phase: N/A
Study type: Interventional

One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with mild TBI and comorbid conditions. When completed, these studies will inform us whether training core attentional self-regulatory control functions via personally-relevant activities will be effective in improving daily life for Veterans with mild TBI and comorbid conditions. The study design will provide a test not only of potential benefits for real life functioning, but also determine to what extent these benefits are related to actual changes in cognitive/behavioral performance and brain networks corresponding to these functions. This project will provide a foundation for future studies to investigate the neural mechanisms that support improvements of cognition and behavior in mTBI.

NCT ID: NCT02916108 Recruiting - Clinical trials for Concussion, Mild Traumatic Brain Injury

Interhemispheric Anterior Delta Desynchronization in Children Who Present to the Emergency Department With Acute Concussion: A Proof of Concept Study

Start date: October 1, 2017
Phase:
Study type: Observational

Approximately 150,000 children present each year to emergency departments (EDs) in the US with concussion and many more are treated by primary care physician, or outpatient specialists. Concussion is defined as a traumatically induced transient disturbance of brain function and involves a complex pathophysiological process. There is a variety of symptoms related to concussion, and the diagnosis of concussion requires the use of symptom-checklist. Since there is a various degree of the severity of those symptoms, the diagnosis is a subjective one and lacks sensitivity. One major problem is that approximately one-third of the children with concussion experience ongoing somatic, cognitive, and psychological or behavioral symptoms, referred to as persistent post-concussion symptoms. A recent study that investigated the validity a 12-point PPCS risk score revealed that it had modest validity (0.71). Moreover, one of the greatest concerns is the child's schedule return to activity. Since the basic mechanism for concussion is acceleration/ deceleration movement of axons, it is likely to be expressed in desynchronization of delta wave activity between anterior hemispheres as seen in pathological problems related to attention and/ or working memory). The aim of this proof-of-concept study is to find-out whether interhemispheric desynchronization of delta waves (IHDD) in the anterior hemispheres can identify acute concussion in children. If the investigators find that IHDD can accurately diagnose acute concussion, a second objective will be to examine whether this index can be a useful tool in the follow up of patients with persistent post-concussion symptoms.

NCT ID: NCT02855034 Recruiting - Clinical trials for Traumatic Brain Injury

Evaluation of Discriminating Power of Two Biomarkers in the Evaluation of Cerebral Lesions Due to Head Injuries in Infants and Children

TCOP100
Start date: May 27, 2016
Phase: N/A
Study type: Interventional

Head injury is a frequent motive of consultation in paediatric emergency units and the first cause of mortality in infants of more than one year old in developped countries. The indication of performing cerebral CT scans currently depends on clinical decision based on recommendations used in adults. In this way, 60 to 90% of scans are normal in children with head injury. CT scan is expensive and irradiating with the risk of increasing the cancer in children. Protein S100B and copeptin are biomarkers which have shown their ability to detect cerebral lesion in children with head injury. (protein S100B and /or in adults protein S100B and copetin). It is the first clinical biological evaluation of severity of head injury based on dosing of copeptin alone or associated with protein S100B. Furthermore, the evaluation of the biomarkers GFAP, NFL, Tau and UCHL-1 is today necessary from a scientific point of view and to optimize the diagnostic and prognostic value of these biomarkers which can be combined. Indeed, these protein biomarkers are biologically linked to the protein S100B and copeptin, and will allow a more specific and more thorough evaluation of the presence of brain damage at the cellular level. More specifically, the measurement of the S-100B and GFAP proteins will allow evaluation of gliovascular damage while those of copeptin, NFL, Tau and UCHL1 proteins will allow evaluation of neuronal damage. The assay of these different biomarkers will also be carried out on a control population, without head injury or neurological or inflammatory pathologies, in order to establish the standards of these biomarkers on a pediatric population of similar age.

NCT ID: NCT02808078 Recruiting - Stroke Clinical Trials

Gait Adaptation for Stroke Patients With Augmented Reality

GASPAR
Start date: June 2016
Phase: N/A
Study type: Interventional

The GASPAR trial is a pragmatic, parallel-arms, single-center, non-blinded, superiority randomized control trial in neurorehabilitation. The main objective is to test whether a 4 weeks gait rehabilitation program that uses augmented reality is superior to a conventional treadmill training program of equivalent intensity. Baseline assessments precede allocation, which consists in blocking randomization (2:1 ratio) with stratification according to the disease etiology. Post-intervention assessments serve to compare the short-term efficacy of the intervention between the two groups. Three months after discharge, follow-up assessments take place to detect potential long-term effects.

NCT ID: NCT02795052 Recruiting - Stroke Clinical Trials

Neurologic Stem Cell Treatment Study

NEST
Start date: June 2016
Phase: N/A
Study type: Interventional

This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http://mdstemcells.com/nest/