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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT03937947 Recruiting - Clinical trials for Traumatic Brain Injury

Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study

TARDIS
Start date: September 28, 2019
Phase:
Study type: Observational

Whilst deep vein thrombosis (DVT) is common following traumatic brain injury (TBI), optimal timing and safety of pharmacological prophylaxis is uncertain. Paradoxically the harm associated with the occurrence of is also unclear. This study is an observational pilot that aims to define the incidence of proximal DVT in patients with moderate to severe TBI. It seeks prospectively to determine if there is an association between DVT and outcome. It also seeks to explore possible associations between the occurrence of DVT and the incidence of lung injury and/or ventilator associated pneumonia.

NCT ID: NCT03932500 Recruiting - Clinical trials for Brain Injuries, Traumatic

Outcomes of Traumatic Brain Injury and External Validation of CRASH Prognostic Model

Start date: March 22, 2018
Phase:
Study type: Observational

As per World Health Organization (WHO) 2015 report, road injury is the tenth cause of mortality in the world. - 90% of these occur in Low and Middle-Income countries (LMICs) - Amongst Injuries, Traumatic Brain Injuries is the leading cause of morbidity and mortality. - Clinicians have to answer about the prognosis of the injured patient to the anxious near ones on arrival as well as throughout the course of treatment - A multicenter randomized control trial (CRASH)published a prediction model for traumatic brain injury patients - This model was based on data from High Income countries and not from Low and Middle-Income Countries - Hence to fill this gap we aim to study the outcome of patients with Traumatic Brain Injury and also validate the CRASH trial prediction model in traumatic brain injury patient - It is a Prospective Observational Study for a duration of 18 months and the sample size is 500 patients. - Acute Traumatic Brain injury patients >18 years of age admitted in Emergency surgery room. - Patients with chronic head injury and Patients who have been declared brain dead and whose organs have been retrieved are excluded. - Variable are Age, Glasgow coma score, Pupils reaction to light, Major extra cranial injuries, CT Finding. - Outcome of the study is mortality at 14th day and morbidity and mortality after 6 months of head injury.

NCT ID: NCT03907254 Recruiting - Clinical trials for Traumatic Brain Injury

Biopsychosocial Effect of Service Dog Training on Post-traumatic Stress (PTS) and Post Concussive Symptoms

Start date: March 5, 2019
Phase: N/A
Study type: Interventional

Preliminary clinical evidence suggests that Service Members with symptoms of post-traumatic stress disorder (PTSD) or Post Traumatic Stress (PTS) who participate in the Service Dog Training Program (SDTP) report improved physical and psychological outcomes, including those with overlapping symptoms associated with traumatic brain injury (TBI) and post-concussion symptoms (PCS). This study intends to examine the psychological, social, and biological effects of learning how to train a future service dog combined with standard of care for individuals with symptoms of Post-Traumatic Stress (PTS), including those with overlapping TBI and persistent Post-Concussive Symptoms (PCS). Biological, social, and behavioral measures will be collected throughout study participation.

NCT ID: NCT03899532 Recruiting - Clinical trials for Traumatic Brain Injury

Remote Ischemic Conditioning in Traumatic Brain Injury

MOTION
Start date: September 24, 2019
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) is a leading cause of death among trauma patients accounting for one-third of all trauma mortalities. Patients who survive the initial trauma are liable to secondary insults from the ensuing inflammatory state in the brain. Treatment goals are aimed at reducing secondary injury. Maintaining adequate brain perfusion, limiting cerebral edema, and optimizing oxygen delivery are part of established treatment protocols. Numerous therapeutics have been evaluated as potential treatment for TBI with very limited success and there is no medication that alters survival. Various novel therapeutic options have been investigated to prevent the secondary brain injury. Remote Ischemic Conditioning (RIC) is one of these therapies. RIC involves decreasing blood flow to a normal tissue usually the arm by inflating the blood pressure cuff 30mmHg over the systolic blood pressure. The decreased blood flow or ischemia is maintained for 5 minutes followed by releasing the pressure and re-perfusion of the arm. This cycle is usually repeated 4 times. RIC has been shown to improve outcomes in patients with heart attacks, strokes, elective neurosurgeries. A prospective observational study and a randomized clinical trial has shown the protective effect of RIC in TBI patients. Additionally, multiple studies in animals have shown that RIC is neuroprotective after TBI. RIC is non-invasive and harmless except for a little discomfort in the arm. The aim of the study is to evaluate the impact of RIC on long term outcomes in patients with TBI.

NCT ID: NCT03889483 Recruiting - Clinical trials for Traumatic Brain Injury

Neurophysiological Measurements Using the NeuroCatchâ„¢ Platform in Pediatric Concussion

Start date: November 30, 2018
Phase: N/A
Study type: Interventional

EEG signals have been collected and studied since the early 1990's as a way of assessing brain function at a gross level. As early as the 1930's a derivative of the raw EEG signal - event-related potentials (ERPs) - have been computed. The current research is primarily focused on three ERP components: the N100, P300 and N400. Each of the three ERPs have been studied in the academic laboratory for multiple decades. Through this research, a strong understanding has been developed regarding what can affect these components (e.g. task set, emotional state, etc.). However, these signals within various pediatric populations (e.g., those with persistent mTBI symptoms or multiple concussions) are not well characterized. Being able to safely and effectively employ the NeuroCatchâ„¢ Platform in a post-concussive pediatric cohort could provide researchers with the potential to elucidate the persistence of objective measures of impairment, patterns of recovery, and chronicity of problems due to mTBI in children. Secondly, understanding the degree to which these neurophysiological components fluctuate over time is crucial to the understanding of brain functioning. However, for this type of technology to be useful in quantifying brain health in this population,the degree to which a post-concussive pediatric brain naturally fluctuates in its processing capability must be quantified. NeuroCatchâ„¢ Platform has the ability to measure changes in several domains of brain function. These cognitive processes are foundational blocks for some of the highest cognitive processes: information integration and executive functioning.

NCT ID: NCT03882554 Recruiting - Clinical trials for Mild to Moderate Traumatic Brain Injury

PoNS Clinical Experience Program (TBI)

Start date: June 30, 2018
Phase: N/A
Study type: Interventional

- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.

NCT ID: NCT03882502 Recruiting - Aphasia Clinical Trials

Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia

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

The aim of this study is to investigate whether a tDCS-accompanied intensive naming therapy leads to a performance improvement in patients with chronic aphasia induced by a moderate TBI

NCT ID: NCT03881202 Recruiting - Clinical trials for Mild to Moderate Traumatic Brain Injury

PoNS Clinical Experience Program (TBI)

Start date: June 30, 2018
Phase: N/A
Study type: Interventional

- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.

NCT ID: NCT03881176 Recruiting - Clinical trials for Mild to Moderate Traumatic Brain Injury

PoNS Clinical Experience Program (TBI)

Start date: September 21, 2018
Phase: N/A
Study type: Interventional

- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.

NCT ID: NCT03874416 Recruiting - Clinical trials for Moderate to Severe Traumatic Brain Injury

Cognitive Rehabilitation of Working Memory After Moderate to Severe Traumatic Brain Injury

REHAB-MDT
Start date: January 25, 2021
Phase: N/A
Study type: Interventional

The study aims to demonstrate improvement of daily life functioning and improvement of cognitive tests in post traumatic brain injury (TBI) patients suffering from working memory deficit, by a 3-month specific cognitive rehabilitation program, in comparison with patients with usual non-specific rehabilitation of same duration. As secondary objectives, the study aims to: - demonstrate improvement of specific neuropsychological tests of working memory; - demonstrate improvement of non-specific tasks involving working memory; - assess the evolution in not-targeted domains by the specific rehabilitation, which would give evidence of a global cognitive stimulation effect; - demonstrate improvement of social integration ability and quality of life; - demonstrate persistence of effects at 3 months and 6 months after the end of treatment; - demonstrate the acceptability, the tolerance and the feasibility of rehabilitation.