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Craniocerebral Trauma clinical trials

View clinical trials related to Craniocerebral Trauma.

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NCT ID: NCT04837066 Recruiting - Concussion, Brain Clinical Trials

Dynamic Vision Testing and Concussion Management

Start date: August 31, 2021
Phase:
Study type: Observational

The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.

NCT ID: NCT04631484 Recruiting - Head Trauma,Closed Clinical Trials

International Trial of Efficacy of Cytoflavin in Head Trauma

MITRA
Start date: October 8, 2020
Phase: Phase 3
Study type: Interventional

The study will access the efficacy and safety of treatment with CITOFLAVIN® in patients with non-penetrating moderately severe traumatic brain injury (TBI). The study recruits patients 18-60 years with TBI, corresponding to the clinical diagnosis of brain contusion, with GCS score 9 -14 at the time of inclusion , with the estimated time of initiation of therapy within 24 hours from the estimated or established time of trauma, with post-traumatic amnesia, confusion or disorientation and absence of indications for neurosurgery or other surgical intervention under general anesthesia. Cytoflavin® (Inosine + Nicotinamide + Riboflavin + Succinic Acid) is a combination drug, which improves cerebral blood flow, activates metabolic processes in the central nervous system, restores impaired consciousness, promotes regression of neurological symptoms and improvement of cognitive functions of the brain.

NCT ID: NCT04562844 Recruiting - Cognition Disorder Clinical Trials

Assessment and Rehabilitation of Social Cognition in People With Traumatic Brain Injury

CogniSo-TC
Start date: September 24, 2020
Phase: N/A
Study type: Interventional

Patients who have suffered moderate to severe traumatic brain injury (TBI) frequently develop behavioural changes, which can have deleterious consequences on interpersonal relationships, social, family and professional reintegration. They are a source of difficulties (burden) for family and friends. Social cognition covers four functions: recognition of social cues; empathy; attribution of intentions to a third party, or theory of mind; and adjustment of social behaviour according to context. This study has two parts: 1/ Evaluation, using a cognitive approach, of the different components of social cognition after moderate to severe traumatic brain injury, and of its repercussions in daily life and on family and friends. 2/ Creation of a specific re-education method for the different modules of social cognition and study of its effectiveness.

NCT ID: NCT04489160 Recruiting - Clinical trials for Traumatic Brain Injury

Complement Inhibition: Attacking the Overshooting Inflammation @Fter Traumatic Brain Injury

CIAO@TBI
Start date: February 25, 2021
Phase: Phase 2
Study type: Interventional

Severe Traumatic Brain Injury (s-TBI) is a major cause of death and disability across all ages. Besides the primary impact, the pathophysiologic process of major secondary brain damage consists of a neuroinflammation response that critically leads to irreversible brain damage in the first days after the trauma. A key catalyst in this inflammatory process is the complement system. Inhibiting the complement system is therefore considered to be a potentially important new treatment for TBI, as has been shown in animal studies. This trial aims to study the safety and efficacy of C1-inhibitor compared to placebo in TBI patients. By temporarily blocking the complement system we hypothesize limitation of secondary brain injury and more favourable clinical outcome for TBI patients due to a decrease in the posttraumatic neuroinflammatory response.

NCT ID: NCT04423198 Recruiting - Clinical trials for Mild Traumatic Brain Injury

HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma

HeadSMART II
Start date: December 31, 2020
Phase:
Study type: Observational

The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in the diagnosis and prognosis of patients with mild traumatic brain injury, by incorporating blood biomarkers, clinical assessments, and tools to measure associated neurocognitive impairments.

NCT ID: NCT04279431 Recruiting - Concussion, Brain Clinical Trials

Follow-up of mTBI Patients Discharged From the ED Using Standard Clinical Triage Including BrainScope One

MEDO
Start date: May 25, 2020
Phase:
Study type: Observational

The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC) algorithm, with focus on SIC negative classification. In addition, to assess functional impairment (concussion) in these patients, results from Brain Function Index (BFI) or Concussion Index (CI) algorithms will be used for analysis.

NCT ID: NCT04230577 Recruiting - Clinical trials for Traumatic Brain Injury

Photobiomodulation to Improve Cognition in TBI, With fMRI

Start date: August 7, 2019
Phase: Early Phase 1
Study type: Interventional

The purpose of this small, research study is to examine effectiveness of an at-home application of an experimental intervention, on thinking and memory in mild-moderate, closed-head, traumatic brain injury cases. The experimental intervention is light-emitting diode (LED) therapy, which is applied to the scalp and through the nose using a head frame device. Participants are expected to complete two, 5-week series of LED treatments, at home, 3 times a week. There will be a 1-month period between the two series. Each home treatment is 20 minutes. Participants will be trained to use the head frame device, in-office. The head frame device falls within the FDA category General Wellness, low-risk devices, and no medical claims are made. A two-hour paper and pencil testing (4 visits) and a one-hour MRI (3 visits) will be administered before and after each treatment series. Participants may be in the study for about 4 months. This study is supported by Vielight, Inc., Hayward, CA/ Toronto, Canada

NCT ID: NCT04212754 Recruiting - Clinical trials for Traumatic Brain Injury

Management and Outcomes Following Emergency Surgery for Traumatic Brain Injury

GNOS
Start date: November 1, 2018
Phase:
Study type: Observational

Primary aim: The primary aim of the study is to compare survival to discharge (or survival to 14 days post-operatively, whichever comes first) following emergency surgery for traumatic brain injury (TBI) across Human Development Index settings. Primary outcome measure: The primary outcome measure will be survival to discharge (or survival to 14 days post-operatively, whichever comes first) Primary comparison: Between country groups defined by human development index. Centre eligibility: Any hospital or clinic worldwide performing emergency surgery for traumatic brain injury is eligible to participate. Patient eligibility: All adult and paediatric patients admitted to the participating institution with a traumatic brain injury for which they receive emergency surgery during the selected 30-day inclusion period are eligible for inclusion in the study. Team: Individual hospital teams with up to four people, collecting data for 30 days. Time period: Local study teams may select any 30-day period from the 1st of November 2018 and the 31st of December 2019 to start their study. Patients operated on who meet the inclusion criteria between 00:01 on day 0 and 23:59 on day 30 of the selected study period will be included. Validation: We will employ a method of data validation in every centre that will give us a quantitative estimate of case ascertainment that is feasible even in low-resource centres.

NCT ID: NCT04205565 Recruiting - Clinical trials for Craniocerebral Injury

Study on Clinical Effectiveness of L-Oxiracetam Injection

Start date: September 30, 2019
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, positive drug/placebo parallel controlled, multicenter, phase III clinical trial of L-oxiracetam injection to improve memory and cognitive Impairment in patients with craniocerebral injury.

NCT ID: NCT04109430 Recruiting - Severe Brain Injury Clinical Trials

Study of PbiO2 Variation by Body Temperature and Capnia in Severe Head Trauma Patients Treated With Targeted Temperature Control

TODAY
Start date: March 1, 2019
Phase:
Study type: Observational

Serious head trauma is a common and pathology and responsible of high morbidity and mortality. The major challenge, from the very first hours, is to limit cerebral ischemia by controlling secondary brain injury factors. These parameters must be integrated early in order to guide the better cerebral resuscitation. Brain monitoring is multimodal:transcranial Doppler, intracranial pressure sensor, cerebral tissue pressure in O2. In the case of refractory intracranial hypertension to well-conducted medical treatment, targeted temperature control showed its efficacy on the control of intracranial pressure. There are few data in the literature on PbtO2 modifications during therapeutic hypothermia. PbtO2 monitoring is now commonly used according to literature data, showing the benefit of the latter but the interpretation of its values during the phase of targeted temperature control is not known. Due to the lack of data on the variation of values of PbtO2 during the hypothermia phase, values falsely comfortable or falsely weak could lead respectively to a lack of support of an episode of tissue hypoxia or the introduction of unjustified aggressive therapeutics.