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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT04087486 Active, not recruiting - Clinical trials for TBI (Traumatic Brain Injury)

Validation of an Ecological Organization and Problem Solving Test (TEM-PRO) in Vocational Rehabilitation

TEM-PRO
Start date: January 1, 2019
Phase:
Study type: Observational

Standard neuropsychological evaluations after severe TBI (traumatic brain injury) often minimizes the executive deficits, these latter are known to seriously impair return to work. Therefore, we developed an ecological organization and problem-solving test in a vocational setting called the TEM-PRO. The test consists of 4 activities of variable complexity, collection and redaction of information and demands to follow well defined rules.

NCT ID: NCT04077411 Completed - Clinical trials for Severe Traumatic Brain Injury

Approaches and Decisions for Acute Pediatric TBI Trial

ADAPT
Start date: February 20, 2014
Phase:
Study type: Observational

Approaches and Decisions in Acute Pediatric TBI Trial (ADAPT) is an international research study designed to evaluate the impact of interventions on the outcomes of children with severe traumatic brain injury. Pediatric traumatic brain injury (TBI) is the leading killer of children, resulting in more than 7000 deaths and $2 billion in acute care costs each year. Despite this large burden of disease, advances in the field have been limited due to weak evidenced-based guidelines and the limitations of randomized, controlled trials (RCTs) to demonstrate efficacy of single treatment strategies due to wide treatment variability. ADAPT is a practical study design in a novel approach - an observational cohort study designed to evaluate the association of 6 aspects of pediatric TBI care with outcomes using statistical modeling to correct for confounding variables. Completion of this study will provide compelling evidence to change clinical practices, provide evidence for new Level II recommendations for future guidelines and lead to improved research protocols that would limit variability in TBI treatments - helping children immediately through better clinical practices and ultimately through more effective investigation.

NCT ID: NCT04077268 Completed - Clinical trials for Traumatic Brain Injury

Becoming Traumatic Brain Injured Patients at Day 7 of Their Trauma

Start date: July 8, 2019
Phase:
Study type: Observational

To study the future of traumatic brain injured patients at day 7 of their trauma Primary endpoint: Fate, classified as survival with or without sequelae, death. Use of the GOS-E scale to classify survival with or without sequelae. The collection of this scale will be done by telephone contact, 7 days of admission to the emergency room. Secondary judgment criteria: - Compendium of the realization of the CT / time respected between the TCL and the CT / Hospitalization / 2nd CT to realize at 24 hours in the patients treated by TAC or AAP - Application of the recommendations of the French Society of Emergency Medicine 2012: Become 7 days of patients classified according to whether or not the recommendations, . - Become TCL patients under AAP or TAC - Number of reconsultation, rehospitalization, new imaging within 7 days after TCL

NCT ID: NCT04074850 Completed - Quality of Life Clinical Trials

The Long-term Consequences After Traumatic Brain Injury in the Elderly

Start date: August 1, 2019
Phase:
Study type: Observational [Patient Registry]

A better understanding of the injury patterns, injury severity, risk profiles, consequences and impact of Traumatic Brain Injury (TBI) in the elderly population is necessary due to the increasing incidence and prevalence of TBI in this population and its high economic impact on society. Therefore, this study aims at describing the long-term consequences of TBI. In order to achieve that goal, injury patterns, injury severity and risk profiles for TBI in the elderly will be mapped. Moreover, a retrospective assessment of brain damage, co-morbidities and post-traumatic history, and a prospective assessment of cognitive functions and quality of life in a 20 years range after TBI will be performed. Finally, a statistical correlation of TBI and different types of neurodegenerative diseases, and an economic costs analysis will be done. All the obtained results will be used to develop a new prognostic tool for the course of the outcomes of TBI in the elderly population.

NCT ID: NCT04073225 Recruiting - Clinical trials for Traumatic Brain Injury

Optimizing Cognitive, Environmental, and Neuromotor Stimulation in Traumatic Brain Injury

OCEANS-TBI
Start date: January 25, 2020
Phase: N/A
Study type: Interventional

Patients with a history of traumatic brain injury (TBI) are at elevated risk for Alzheimer's disease and related dementias (ADRD). Improvements in TBI treatment may mitigate this risk. Complex motor activities, which combine physical and cognitive demands, have been shown to have well established neurocognitive benefits. This study seeks to address the need for novel TBI interventions optimized for adults with history of TBI by determining the effectiveness of an immersive computer game designed to integrating complex cognitive-motor interventions.

NCT ID: NCT04070092 Suspended - Clinical trials for Traumatic Brain Injury

The Impact of Traumatic Brain Injury in the Elderly

Start date: July 29, 2019
Phase:
Study type: Observational [Patient Registry]

A better understanding of the impact of Traumatic Brain Injury (TBI) in the elderly, in terms of brain damage, cognitive and motor functions, sleep quality and quality of life is necessary due to the increasing incidence and prevalence of TBI in this population and its high economic impact on society. Therefore, this study aims at describing the short-term consequences of TBI by studying injury patterns, injury severity, risk profiles, brain damage, co-morbidities, post-traumatic history, level of dependency, serum-based injury biomarkers, cognitive and motor functions, sleep quality and quality of life 6 months after TBI. All the obtained results will be integrated in a new prognostic tool for the course of the outcomes of TBI in the elderly population.

NCT ID: NCT04068883 Completed - Concussion, Mild Clinical Trials

Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football and soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the efficacy of device to reduce alterations in brain structure relative to amount and magnitude of sustained head impacts. Finally, to show that DTI efficacy and safety results can be prospectively confirmed in a multi-school investigation. Test the null hypotheses of no difference between collar users and non-collar users changes from baseline to end of season for: - Primary: Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL. - Secondary: Alterations in pre-defined DTI metrics is explained by the number of hits, the hit intensity, and the intensity per head impact over the season non-collar users. In addition, secondary analytics on data derived from injury surveillance (musculoskeletal, concussion and symptom/severity scores), behavioral (Trail Making, Postural Sway, Flanker, Task-switching, Near Point Convergence, ADHD and King Devick) or imaging (DTI, fMRI, T1, T2, and MRS) will be evaluated.

NCT ID: NCT04065477 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Improving Time-Based Prospective Memory in TBI

TBPM
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

This research aims to test aspects of a computer-based cognitive rehabilitation program designed to improve thinking skills in individuals with traumatic brain injury (TBI).

NCT ID: NCT04063215 Active, not recruiting - Clinical trials for Traumatic Brain Injury

A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy

Start date: January 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury in adults.

NCT ID: NCT04058379 Active, not recruiting - Trauma, Brain Clinical Trials

Artificial Intelligence Analysis of Initial Scan Evolution of Traumatic Brain Injured Patient to Predict Neurological Outcome

RADIOMIC-TBI
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

We assume that an early iterative automatic CT scan analysis (D0, D1 and D3) by different AI approaches will allow an early differentiation of the tissues evolution after TBI. Our objective is to couple theses scan profiles to a neurological evolution, measured by therapeutic intensity.