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Mild Traumatic Brain Injury clinical trials

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NCT ID: NCT05337774 Terminated - Clinical trials for Mild Traumatic Brain Injury

Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury

Start date: June 7, 2021
Phase: Phase 1
Study type: Interventional

The main objective of this interdisciplinary study is to develop an understanding of the molecular imaging features of blast-related mild traumatic brain injury (mTBI) in military personnel, while helping to establish assessment tools that may be of use in diagnosis, determining prognosis, and in future therapeutic clinical trials. Additionally, the objective is to evaluate feasibility of [18F]PI-2620 in the assessment TBI.

NCT ID: NCT04226365 Terminated - Clinical trials for Mild Traumatic Brain Injury

Pediatric Concussion Outcomes

PeCon
Start date: February 15, 2020
Phase: Phase 4
Study type: Interventional

This is a randomized, placebo-controlled, double-blinded trial in which subjects with a post concussive headache meeting inclusion criterion will be assigned to one of two treatment groups: placebo or nortriptyline. Each group will be evaluated at week 0 and again each week for the next 4 weeks of treatment with a concussion survey that rates their symptoms. At the end of 4 weeks the study will be unblinded. It is hypothesized that the addition of nortriptyline to the standard headache treatments will result in more rapid decrease of symptom score than with placebo.

NCT ID: NCT03529799 Terminated - Clinical trials for Mild Traumatic Brain Injury

Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)

Start date: April 20, 2018
Phase: N/A
Study type: Interventional

This study aims to determine the validity and safety of disparity driven vergence using a portable goggle system (I-PAS) using a pseudorandom ternary sequence of frequencies for testing.

NCT ID: NCT03417492 Terminated - Clinical trials for Traumatic Brain Injury

Cerebrovascular Reactivity in American Football Players

Start date: March 1, 2018
Phase: Phase 1
Study type: Interventional

Investigators will measure cerebrovascular reactivity (CVR) using functional near-infrared spectroscopy (fNIRS) and magnetic resonance imaging (MRI) during the chronic phase after repetitive mild traumatic brain injury (rmTBI) as a biomarker of traumatic cerebrovascular injury (TCVI). We hypothesize that CVR will be decreased in patients with rmTBI and that these decreases will correlate with clinical outcomes. Furthermore, we predict that 5 week administration of a phosphodiesterase 5 (PDE5) inhibitor, sildenafil citrate, will augment CVR in patients with a history rmTBI.

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: NCT02849002 Terminated - Clinical trials for Mild Traumatic Brain Injury

Un-blinded Data Collection Study of Concussion Using the BrainPulse(TM)

Start date: July 14, 2016
Phase:
Study type: Observational

The primary objective of this study is to collect un-blinded BrainPulse recordings from youth and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to improve a concussion detection algorithm previously developed by Jan Medical, Inc. Subjects will be followed for 21 days after the initial injury with BrainPulse recordings to study the subject's recovery process. The symptomatic evaluation, physical examination, and BrainPulse recordings will be entered in a database to assess clinical outcome and device utilization.BrainPulse(TM)

NCT ID: NCT02257749 Terminated - Clinical trials for Mild Traumatic Brain Injury

Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion

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

The purpose of this randomized control trial study is to determine if an active rehabilitation (low intensity exercise program) in combination with a comprehensive education intervention (standard care) is more effective than the comprehensive education intervention alone in reducing post-concussion symptoms and improving participation in daily activities in youth who have persistent post-concussion symptoms.

NCT ID: NCT02252315 Terminated - Clinical trials for Mild Traumatic Brain Injury

Written Versus Verbal Education for Mild Traumatic Brain Injury

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

Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or alteration in mental status induced by an external mechanical force to the head. Education about symptoms and reassurance of a prompt recovery usually results in full recovery. However, a subgroup appears to have persistent symptoms and disability. This study will recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable patient characteristics that can delay or prevent full recovery. A secondary aim is to determine if providing education in writing or in-person makes a difference.

NCT ID: NCT02070588 Terminated - Clinical trials for Traumatic Brain Injury

Advanced MRI Applications for Mild Traumatic Brain Injury

TBI
Start date: February 2014
Phase: N/A
Study type: Interventional

This feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and magnetic resonance images (MRI), data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (approximately 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications. Correlations exist over the sub-acute period in clinical neurological and MR data (images, image reads, and RAW data), which may indicate temporal evolution patterns. The intent of this study is to broadly generate potential biomarkers of temporal evolution of mTBI detectable in MR images and data ("MR mTBI biomarkers").