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Brain Concussion clinical trials

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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: NCT02844946 Completed - Chronic Pain Clinical Trials

One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology

Start date: October 3, 2016
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) is the signature wound of Veterans returning from the recent operations in Iraq and Afghanistan (i.e OIF/OEF/OND), with up to 20 percent experiencing persistent post-concussive symptoms. Among Veterans with mild TBI, the majority also experience significant distress, including depression and post-traumatic stress disorder, as well as persistent pain. Importantly, significant stigma is associated with seeking mental health care among Veterans; and poor management of multiple conditions results in increased morbidity and mortality, increased risk for suicide, and significantly decreased quality of life. Thus the challenge for treatment providers is to provide a unified and acceptable intervention for Veterans with these interdependent systemic comorbid concerns. The aim of this proposal is to develop, refine, and evaluate a 1-day trans-diagnostic (i.e., applies to more than one diagnosis) "life skills workshop" to help Veterans develop skills needed to pursue valued goals in the face of life's challenges.

NCT ID: NCT02819778 Completed - Pediatrics Clinical Trials

Study Assessing Evaluation of the Interest of Serum S100B Protein Determination in the Management of Pediatric Mild Traumatic Brain Injury

PROS100B
Start date: November 2, 2016
Phase: N/A
Study type: Interventional

Mild traumatic brain injury (mTBI) is a very common reason for presentation to pediatric emergency departments. So as not to overlook the risk of complications, which occur at a rate of 0-7%, measures such as cranial computed tomography (CCT-scan) and/or short inpatient observation are prescribed. Ultimately, the majority of these measures could be avoided and a large Australian cohort shows that the risk of brain tumors is 2.44 times higher for children who had a CCT-scan (3.24 for age 1-4 years). Assay of a sensitive biomarker in blood, such as the S100B protein, has the potential to reduce the number of these unnecessary measures.

NCT ID: NCT02812225 Completed - Clinical trials for Mild Traumatic Brain Injury

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

Start date: June 2016
Phase:
Study type: Observational

The multi-center study evaluates BrainPulse recordings from subjects with a suspected or confirmed concussion to improve a concussion detection algorithm. Subjects may also consent for a 5 additional follow-ups over a 21-day period to compare the progression of change in their BrainPulse recordings.

NCT ID: NCT02776462 Completed - Brain Injuries Clinical Trials

Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients

DETECT
Start date: June 2016
Phase:
Study type: Observational

The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED) or concussion clinic.

NCT ID: NCT02771106 Completed - Clinical trials for Traumatic Brain Injury

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

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

Mild TBI subjects will initially be identified by providers in the Hennepin County Medical Center (HCMC) TBI Clinic. The subjects will then undergo objective testing by the developmental optometrist to confirm if they do or do not have vision dysfunction related to the mTBI. At the Center of Magnetic Resonance Research (CMRR) located at the University of Minnesota (U of M), the whole brain will be imaged using resting state and task functional MRI and diffuse tensor imaging (DTI) using a high field 3 Tesla (T) MRI. The subjects will then receive neurovision rehabilitation if they are in the vision dysfunction group. This treatment is standard care. Both groups will then undergo repeat objective vision testing by the developmental optometrist at 3 and 6 months to confirm that vision dysfunction has resolved. Resting state and task fMRI and DTI will be done at the same time to compare functional and structural connectivity changes between the 2 groups.

NCT ID: NCT02757053 Terminated - Brain Injuries Clinical Trials

Screening Brain MRI in High School Football: Does the Guardian Cap Reduce the Risk of Traumatic Brain Injury

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

Screening Brain magnetic resonance imaging (MRI) with Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post season on high school football players. One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only. The investigators will compare outcomes of ImPACT scores and MRI findings between the two groups to see if there is a statistical difference in reduction of injury and to establish what the baseline level of MRI findings related to injury from high school football is as well as what the baseline level of injury is prior to the start of the season.

NCT ID: NCT02754206 Terminated - Brain Concussion Clinical Trials

Cerebral Blood Flow Regulation and Concussions

Start date: January 2016
Phase:
Study type: Observational

The purpose of this study is to understand how biochemical markers in blood, balance disturbances, and cognitive performance are related to brain blood flow changes after a concussion.

NCT ID: NCT02723344 Completed - Clinical trials for Post Traumatic Stress Disorder

Biological Signatures, Probiotic Among Those With mTBI and PTSD

Start date: August 1, 2016
Phase: Phase 1
Study type: Interventional

Exaggerated inflammation in the body and brain is thought to play a role in the vulnerability to and aggravation and perpetuation of adverse consequences among those with co-occurring mild TBI (mTBI) and post-traumatic stress disorder (PTSD). The proposed study begins the process of investigating the use of a natural immunoregulatory/anti-inflammatory probiotic to treat chronic symptoms associated with co-occurring mTBI and PTSD among Veterans. By looking at the impact of probiotic supplementation on biological signatures of increased inflammation, as reflected by the gut microbiota, gut permeability, and biomarkers of peripheral inflammation, this study may lead to the identification of a novel intervention for the treatment of symptoms associated with these frequently co-occurring conditions.

NCT ID: NCT02721537 Completed - Concussion, Mild Clinical Trials

Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes

TRMC-004
Start date: September 2016
Phase: N/A
Study type: Interventional

Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as measured by 31P MRS?