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Brain Concussion clinical trials

View clinical trials related to Brain Concussion.

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NCT ID: NCT03381638 Completed - Clinical trials for Traumatic Brain Injury

Understanding Concussion/Mild Traumatic Brain Injury

Start date: January 1, 2016
Phase:
Study type: Observational

Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice.

NCT ID: NCT03367507 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Sub-maximal Exercise Prescription in Adolescents With Physiological Post-concussion Disorder

Start date: December 10, 2017
Phase: N/A
Study type: Interventional

Although the vast majority of individuals sustaining a sport-related concussion (SRC) will receive medical clearance to return to sport within 7-10 days, approximately 30% of children and adolescents reporting to the emergency department will experience symptoms that last longer than a month. Research has demonstrated that exercise below the threshold that results in increases in symptoms, beyond those experienced at rest, (sub-symptom threshold aerobic exercise) may be beneficial in recovery. However, the optimal amount and intensity of aerobic exercise for an individual to experience the most beneficial outcomes is currently unknown. Unfortunately there are limited Randomized Controlled Trials (RCT's) evaluating the benefits of aerobic exercise in a youth population. The current evidence includes studies with relatively small sample sizes, unreliable measurements of physical activity (self-report), and inherent biases through inadequate blinding. There is a need to develop and validate evidence-informed interventions as a means of treatment for limiting time loss from sport, and school in adolescents who experience persistent symptoms of sports related concussion beyond 10 days.

NCT ID: NCT03345550 Terminated - Clinical trials for Mild Traumatic Brain Injury

OPTIMA-TBI Pilot Study

OPTIMA
Start date: September 12, 2017
Phase: Phase 2
Study type: Interventional

This is a double-blind, randomized controlled trial comparing the effect of omega-3 fatty acid versus placebo on blood biomarkers of brain injury, inflammation and neurogenesis.

NCT ID: NCT03342612 Terminated - Clinical trials for Mild Traumatic Brain Injury

Multimodal Neuroimaging Analysis After Mild Traumatic Brain Injury

CHANGE-TBI
Start date: July 18, 2016
Phase: N/A
Study type: Interventional

Mild Traumatic Brain Injury (mTBI), including concussion, is a real public health problem. Indeed mTBI might induce long-term brain disorders with increased risk of neurodegenerative diseases and the healthcare costs can be significant for both the individual and the society. However mTBI is called the "silent epidemic", because of the lack of research in this field in France as well as in the rest of the world. Most of the time, mTBI is associated with sports injuries, road traffic accidents and falls. The risk of neurodegenerative diseases is significantly increased with the repetition of mTBI, which may have a cumulative effect. In this context, playing football (or 'soccer') is associated with a high risk of concussion and with frequent head-ball contacts which are repeated during the training and matches. Moreover, football is the most popular team sport in the world, with more than 265 million players. The long-term impact of "heading" in football is still debated in the literature. Nevertheless, several studies suggest the possible emergence of early neurocognitive disorders. Otherwise, while mTBI is usually characterized by normal brain images using traditional neuroimaging techniques, microscopic anatomical changes might be detectable by new neuroimaging techniques. According to recent studies, cognitive dysfunctions could be based on these microstructural changes in the gray matter and white matter, secondary to the primary mechanical injury. Studies that have examined the structural changes in the brain white matter in football players are rare and lack of evidence regarding the consequences of accumulated brain impacts explains the lack of preventive measures in this sport. In addition, post-traumatic secondary lesions cause functional alterations of the neurovascular unit and its effect on cerebral perfusion may play a crucial role, which has never been yet explored in humans over the long term. In this research, the investigators will develop a unique multi-modal neuroimaging protocols to assess brain changes after minor head trauma and over the time. Investigators want to perform magnetic resonance imaging (MRI) to assess cerebral blood flow using Arteria Spin Labelling (ASL), structural changes using Diffusion Tensor Imaging (DTI), susceptibility weighted imaging (SWI), and functional changes using BOLD resting-functional MRI.

NCT ID: NCT03319966 Completed - Clinical trials for Mild Traumatic Brain Injury

Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury

Start date: October 18, 2017
Phase:
Study type: Observational

The purpose of this single center, longitudinal, pilot study is to provide evidence for the use of an eye tracking system as an objective tool to identify mild traumatic brain injury (mTBI) related oculomotor dysfunction (OMD) and predict the effectiveness of neurovision rehabilitation (NVR) of OMD. Eye tracking visual stimulus measurements will be compared to objective developmental optometrist (OD) diagnosis and assessments. It will be determined whether an eye tracking system can predict the presence or absence of mTBI related OMD and whether mTBI patients who have OMD based on the eye tracking system will respond positively to NVR.

NCT ID: NCT03313505 Completed - Clinical trials for Mild Traumatic Brain Injury

PROtein S100B for Mild Trauma of the HEad in Emergency Patients

PROMETHEE
Start date: May 14, 2018
Phase:
Study type: Observational

Brain injury is a frequent purpose for consultation in emergency services. Management of brain injury is time and resource consuming, combining clinical monitoring and imaging. The stage prior to the management of the victims of brain injury is stratification of the severity, potential or proven. Severe brain injury requires emergent brain CT-scan, ideally within one hour of the first medical contact. Patients requiring this strategy present with focused neurological deficit, Glasgow score <15 to 2 hours after the trauma, suspicion of open fracture of the skull or dish pan fracture, any signs of fracture of the skull base (hemotympanum, bilateral peri-orbital ecchymosis), otorrhea or rhinorrhea of cerebrospinal fluid, more than one episode of vomiting in adults, and posttraumatic convulsion. Patients benefiting from anticoagulant therapy are included in this category. Victims of brain injury that do not fall into this category are considered less critical. By definition, mild traumatic brain injury : - a trauma of the cephalic extremity : - whose Glasgow score (30 min after the trauma or during the consultation) is 13-15, - associated with one or more of the following: confusion; disorientation; loss of consciousness of 30 min or less; post-traumatic amnesia of less than 24 hours; other transient neurological abnormalities (focal signs, epileptic seizures, non-surgical intracranial lesion). Among these patients, some are considered at risk of developing intracerebral lesions. Nevertheless, it should be noted that the prevalence of hemorrhagic complications is radically different between patients with a Glasgow score of 13 and those with a score of 15. Thus, the recommendations suggest a brain scan without injection of contrast media within 4 to 8 hours for patients with the following characteristics : - a retrograde amnesia of more than 30 minutes, - a loss of consciousness or amnesia associated with: - either a risk mechanism (pedestrian overturned by a motor vehicle, ejection of a vehicle, falling by more than one meter), - or an age> 65 years, - or coagulation disorders, including the use of platelet aggregation therapy. Patients who fall outside this definition are considered low risk of complication and should not benefit of imaging. Data from the scientific literature show that an early brain CT-scan allows identification of post-traumatic lesions in this population. Nevertheless, organizational problems, including the availability of the imaging, radiation, and disruption of surveillance related to patient displacement, are limitations to this strategy. In contrast, the low cost-effectiveness of CT scan is often advocated in patients with mild traumatic brain injury. For example, in the Octopus study, 52 of 1316 patients who received CT scan after mild head trauma had an intracerebral lesion. Among these patients, 39 (3%) had intracerebral lesion related to trauma; for 13 (1%) patients, the link with the trauma was uncertain. In fact, the search of alternatives for a safer, more conservative, more efficient practice, one of the objectives of which is to limit the undue use of cerebral scanning. Thus, many teams have been interested in the use of biological variables to guide the decision to use imagery. Among candidate biomarkers, the S100B protein has been the subject of many evaluations which allow it to be used in current practice. Indeed, the increase of the S100B protein carried out within 3 hours following a mild head trauma makes it possible to identify the patients at risk of intracerebral lesion and to target the indications of imaging. The purpose of the registry is to describe the use, interpretation and performance of the S100B protein in its use at bedside in emergency medicine.

NCT ID: NCT03306563 Completed - Clinical trials for Traumatic Brain Injury

Rapid Biochemical Diagnostics of Traumatic Brain Injury

Start date: December 28, 2017
Phase: N/A
Study type: Interventional

The objective of the study is to confirm the clinical relevance of the novel biomarker for traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected from a) patients with suspected TBI (isolated), b) patients with orthopedic injury, and c) healthy controls. The sponsor will do biochemical investigations for the samples to evaluate the presence, level and structure of the targeted biomarker.

NCT ID: NCT03265912 Completed - Clinical trials for Mild Traumatic Brain Injury

Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment

Start date: January 26, 2017
Phase:
Study type: Observational

mTBI is widely recognized as a major public health concern in the United States and worldwide. mTBI diagnosis remains a clinical challenge as no single test can diagnose every concussion. Recent advances in EEG evoked response potential analysis have led to a novel technique for assessing brain network activation (BNA) patterns. This study purpose is to study this BNA technology in individuals who have sustained a concussion.

NCT ID: NCT03249675 Withdrawn - Concussion, Brain Clinical Trials

Evaluating a Novel Method of EEG Evoked Response Potential Analysis in Concussion Assessment, Young Adults and Adults

Start date: July 5, 2017
Phase:
Study type: Observational

Concussion is widely recognized as a major public health concern in the United States and worldwide. Although many concussions resolve completely and spontaneously, almost 1 in 4 patients will go on to experience post-concussion syndrome (PCS). In the United States, PCS diagnoses have increased 100% from 2010-2015. Concurrently, recent advances in EEG evoked response potential analysis have led to a novel technique for assessing brain network activation (BNA) patterns. The purpose of this study is to explore the use of BNA in individuals who are diagnosed with PCS or have the risk of experiencing PCS due to a recent injury.

NCT ID: NCT03244475 Completed - Clinical trials for Post-traumatic Stress Disorder

Transcranial Electrical Stimulation for mTBI

TESmTBI
Start date: February 1, 2017
Phase: N/A
Study type: Interventional

mTBI is a leading cause of sustained physical, cognitive, emotional, and behavioral deficits in OEF/OIF/OND Veterans and the general public. However, the underlying pathophysiology is not completely understood, and there are few effective treatments for post-concussive symptoms (PCS). In addition, there are substantial overlaps between PCS and PTSD symptoms in mTBI. IASIS is among a class of passive neurofeedback treatments that combine low-intensity pulses for transcranial electrical stimulation (LIP-tES) with EEG monitoring. Nexalin is another tES technique , with FDA approvals for treating insomnia, depression, and anxiety. LIP-tES techniques have shown promising results in alleviating PCS individuals with TBI. However, the neural mechanisms underlying the effects of LIP-tES treatment in TBI are unknown, owing to the dearth of neuroimaging investigations of this therapeutic intervention. Conventional neuroimaging techniques such as MRI and CT have limited sensitivity in detecting physiological abnormalities caused by mTBI, or in assessing the efficacy of mTBI treatments. In acute and chronic phases, CT and MRI are typically negative even in mTBI patients with persistent PCS. In contrast, evidence is mounting in support of resting-state magnetoencephalography (rs-MEG) slow-wave source imaging (delta-band, 1-4 Hz) as a marker for neuronal abnormalities in mTBI. The primary goal of the present application is to use rs-MEG to identify the neural underpinnings of behavioral changes associated with IASIS treatment in Veterans with mTBI. Using a double-blind placebo controlled design, the investigators will study changes in abnormal MEG slow-waves before and after IASIS treatment (relative to a 'sham' treatment group) in Veterans with mTBI. For a subset of participants who may have remaining TBI symptoms at the end of all IASIS treatment sessions, MEG slow-wave changes will be recorded before and after additional Nexalin treatment. In addition, the investigators will examine treatment-related changes in PCS, PTSD symptoms, neuropsychological test performances, and their association with changes in MEG slow-waves. The investigators for the first time will address a fundamental question about the mechanism of slow-waves in brain injury, namely whether slow-wave generation in wakefulness is merely a negative consequence of neuronal injury or if it is a signature of ongoing neuronal rearrangement and healing that occurs at the site of the injury.