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Brain Injuries clinical trials

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NCT ID: NCT04496076 Completed - Clinical trials for Traumatic Brain Injury

COVID-19 Brain Injury

Start date: April 2, 2020
Phase:
Study type: Observational

A prospective cohort minimal risk study to determine the impact of the COVID-19 crisis on outcomes of neurologically injured ICU patients.

NCT ID: NCT04495686 Active, not recruiting - Alzheimer Disease Clinical Trials

An Innovative Supportive Care Model for Dementia and Traumatic Brain Injury

Start date: March 3, 2021
Phase: N/A
Study type: Interventional

There are an increasing number of people in the U.S. with Alzheimer's disease and other dementias. Traumatic brain injuries (TBIs) are also common among both civilians and military personnel, and TBIs increase a person's risk for dementia. Providing care for a person with dementia is stressful. Dementia caregivers can experience difficulties including stress, depression, and reduced quality of life. Coordinated dementia care is known to benefit people with dementia and their caregivers. However, many caregivers do not have access to these supportive programs. Our project studies the benefits of telehealth as a new way for caregivers to receive coordinated dementia care services. We will offer 75 caregivers a 12-month caregiver support program delivered using telehealth (for example phones, tablets, computers). Caregivers of both Alzheimer's disease and TBI-related dementia will be included, and the program will be evaluated for effectiveness in both groups as well as in a control group. The information from our study will help improve quality of life for caregivers and individuals with dementia, including military members and Veterans. Our results will also help both civilian and military health professionals develop effective programs to support families living with dementia. Policy makers and organizational leaders can use the information to fund programs that best help families and communities facing dementia and TBI dementia.

NCT ID: NCT04495192 Recruiting - Brain Injuries Clinical Trials

Predictors of Better Outcomes After Severe Acquired Brain Injuries

FP-GCA
Start date: June 9, 2020
Phase:
Study type: Observational [Patient Registry]

Severe Acquired Brain Injury is defined as a traumatic, post-anoxic, vascular or other brain damage that causes coma for at least 24 hours and leads to permanent disability with sensorial, motor, cognitive or compartmental impairment. In this context, an accurate characterization of individual patients' profile in terms of neuronal damage, potential for neuroplasticity, neurofunctional and clinical state could allow to plan tailored rehabilitation and care pathway on the basis of solid prognostic information, also for optimizing resources of the National Health care systems and enhance ethical decisions. Patient profiling should encompass measures and procedures easily available at the bedside, and with affordable time, resource, and money-costs to determine a real impact on National Health systems. The aim of the study is identifying patient profiles in terms of clinical, neurophysiological and genetical aspects with better long-term outcome in order to plan tailored therapeutic interventions.

NCT ID: NCT04490122 Not yet recruiting - Oxidative Stress Clinical Trials

Impact of Mode of Anesthesia on Ischemia Modified Albumin in Patients With Traumatic Brain Injury

Start date: July 23, 2020
Phase:
Study type: Observational

In the current study the investigators intend to evaluate the mode of anesthesia on ischemia modified albumin and outcome in patients with traumatic brain injury undergoing emergency craniotomy

NCT ID: NCT04490005 Completed - Acute Brain Injury Clinical Trials

Outcome pRognostication of Acute Brain Injury With the NeuroloGical Pupil indEx

ORANGE
Start date: November 2, 2020
Phase:
Study type: Observational [Patient Registry]

The use of quantitative, automated, infrared technology for pupillary examination has long been used in ophthalmology and anesthesiology research. Its interest in neurocritical care has progressively grown, in parallel with the advancements in device technology. In this regard, the use of the noninvasive NPi®-200 pupillometer (Neuroptics, Laguna Hills, California, USA) allows the measurement of a series of dynamic pupillary variables (including the percentage pupillary constriction, latency, constriction velocity, and dilation velocity), which can be integrated into an algorithm, to compute the Neurological Pupil index (NPi). The NPi is a proprietary scalar index with values between 0 and 5 (with a 0.1 decimal precision), an NPi value < 3 indicating an abnormal pupillary reactivity. Importantly, the NPi is not influenced by sedation-analgesia, at the doses used in neurocritical care practice, and by mild hypothermia. Preliminary single-center data recently demonstrated that abnormal NPi is associated with worse outcome in patients with traumatic and hemorrhagic ABI, and can be a useful adjunct for ICP monitoring and therapy. There is currently a great need for quantitative tools to predict early prognostication in ABI patients, and the NPi appears of potential great value. We hypothesize that: 1. Abnormal NPi (defined as NPi <3) are strongly predictive of poor GOS-E (1-4) at 6 months after the acute event. 2. NPi=0 is strongly predictive of mortality (GOS 1). 3. Abnormal NPi is predictive of a higher ICP 20 index (number of end-hourly measures of ICP >20 mm Hg divided by the total number of measurements, multiplied by 100) and a greater burden of interventions needed to control ICP (measured by the Therapy Intensity Level scale for ICP management, Therapy Intensity Level (TIL) 4). Methods This international multicentre prospective observational study aims to recruit >400 patients admitted to intensive care units. Duration of the study 18 months, including 12-month of recruitment based on 60 patients/centre plus 6 months GOS-E follow-up.

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: NCT04489082 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

Near-Infrared Laser Stimulation for Various Neurological Conditions

Start date: January 2, 2021
Phase: N/A
Study type: Interventional

The study will evaluate the safety and feasibility of near infrared therapy as an intervention for patients with refractory depression, anxiety, neurodegenerative disease, and traumatic brain injury.

NCT ID: NCT04487275 Recruiting - Clinical trials for Traumatic Brain Injury

MLC901 for Moderate to Severe Traumatic Brain Injury (Specified Drug Code)

MLC901
Start date: August 20, 2018
Phase: Phase 4
Study type: Interventional

Patients with a diagnosis of moderate to severe traumatic brain injury (TBI) will be enrolled. Subjects will be randomly assigned to receive either MLC901 (Specified Drug Code) or placebo capsules three times per day over 6 months. Evaluation of patients will be carried out at baseline as well as at 3-month and 6-month follow-up visits. Modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) will be used to examine patients. Efficacy will be evaluated by comparing these two scores between the 2 groups at follow-up visits.

NCT ID: NCT04485494 Completed - Clinical trials for Traumatic Brain Injury

Blood-based Biomarkers for the Prognosis of Sports Related Concussion

Start date: July 1, 2018
Phase:
Study type: Observational

The diagnosis of sports related concussion still relies heavily on a subjective assessment. In this study the investigators want to assess the prognostic value of blood-based biomarkers with recovery from concussive episodes over specific time points post-injury. Our research aims to (1) assess that the World Rugby's head injury assessment (HIA) can identify that a concussion has taken place by measuring specific biomarkers in the blood and (2) to track these biomarkers over time post-injury as a means to assess player health.

NCT ID: NCT04478812 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Tbit System Precision and Correlation of Different Blood Samples

Start date: September 15, 2024
Phase: N/A
Study type: Interventional

The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™ System by 3 different operators.