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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT02868684 Completed - Clinical trials for Posttraumatic Stress Disorder

Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study

Start date: August 2016
Phase:
Study type: Observational

This longitudinal cohort study aims to detect the topographical nature of the white matter microstructure and resting state functional connectivity patterns across the whole brain in the evolution of pathology as a function of time following mild TBI. All consecutively patients with the non-contrast head CT because of acute head trauma from the local emergency department (ED) formed the initial population of this study. Age, sex, education-level matched healthy controls will also be enrolled. The initial scan will performed within 7 days post-injury. Clinical assessment was performed within 24 hours of MR imaging and included a broad neuropsychological and symptom assessments. Follow-up examination will conduct at 1 month, 3 month, 6-12 months.

NCT ID: NCT02868671 Completed - Clinical trials for Mild Traumatic Brain Injury

Acupuncture for Mild Traumatic Brain Injury:A Functional Magnetic Resonance Imaging Study

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

The overall goal of this study is to examine if acupuncture intervention can reduce the post-concussion symptom (PCS), and affective and cognitive complaints among mild traumatic brain injury (TBI). This study also hypothesized that compared to those in the sham acupuncture and waiting list control groups, patients in the real acupuncture group will have fewer symptoms of depression, sleep problems and post-concussion symptoms.

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: 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: NCT02849223 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Transcranial Direct Current Stimulation (TDCS) as an Intervention for Patients With Traumatic Brain Injury

Start date: July 2016
Phase: Phase 2
Study type: Interventional

The primary aim of this study is to assess the magnitude of transcranial direct current stimulation (tDCS) -induced cognitive and functional change in patients with mild traumatic brain injury. This study will also attempt to identify biomarkers associated with treatment response. Last, acceptability and tolerability of procedures will be assessed. To accomplish these aims, a randomized, double-blind, sham-controlled, parallel groups, pilot study will be conducted in which participants are assigned to 24 sessions of tDCS or sham stimulation offered concurrent with working memory training. Neural efficiency will be measured with electroencephalogram (EEG) pre and post-intervention.

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: NCT02838082 Completed - Clinical trials for Traumatic Brain Injury

Optimized Sleep After Brain Injury: Sleep Hygiene Intervention After Traumatic Brain Injury

OSABI
Start date: August 2015
Phase: N/A
Study type: Interventional

OSABI is a pilot study of a sleep hygiene protocol for sleep disruptions associated with TBI during inpatient rehabilitation. Twenty participants will be allocated (by minimization) either into a standard of care protocol or a sleep hygiene protocol for 4 weeks. Sleep efficiency (via actigraphy), post traumatic amnesia (OLOG), agitation (Agitated Behavior Scale) and cognitive function (Confusion Assessment Protocol) will be monitored during the trial period to examine relationships among them.

NCT ID: NCT02836951 Completed - Clinical trials for Traumatic Brain Injury

Rapid Diagnostics for Traumatic Brain Injury (TBI)

Start date: September 2016
Phase:
Study type: Observational

Novel biomarkers of traumatic brain injury (TBI) have been discovered in laboratory animal models. The objective of this study is to find whether similar markers are detectable in the body fluids of human subjects that have sustained a TBI.

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.