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Brain Injuries clinical trials

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NCT ID: NCT06375421 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

Pilot and Feasibility of MEMI for Chronic Traumatic Brain Injury

Start date: April 3, 2024
Phase: N/A
Study type: Interventional

This is a pilot and feasibility study for a mobile phone-delivered intervention for memory, called MEMI (memory ecological momentary intervention), that was designed to support adults with chronic traumatic brain injury with their memory. The goal of the study is to examine the feasibility and acceptability of MEMI and to assess preliminary efficacy as to whether technology-delivered spaced memory retrieval opportunities improve memory in people with and without a history of chronic traumatic brain injury.

NCT ID: NCT06314464 Enrolling by invitation - Clinical trials for Mild Traumatic Brain Injury

Portable Mixed Reality-based Platform for Assessment of Progress in Multisensory Rehabilitation Strategies Post-TBI

Praxis
Start date: February 12, 2024
Phase: N/A
Study type: Interventional

The goal of this comparative pilot study is to provide evidence that Praxis, a portable testbed with low-cost wearable sensors and a mixed reality environment, can deliver effective multisensory rehabilitation exercises with military face-validity in a military service member (SM) population after mild Traumatic Brain Injury (mTBI). The main questions this comparative pilot study aims to answer are: - Can the Praxis testbed provide feasible/acceptable 4-week multisensory rehabilitation for SMs with post-acute mTBI? - Can Praxis detect and influence measurable changes in readiness performance during mTBI recovery? Fifteen SMs with post-acute mTBI from the Center for the Intrepid's Special Operations Performance and Recovery (SPaR) Program will participate in the multisensory vestibular rehabilitation regimen. These SMs will go through 4 weeks of multisensory vestibular rehabilitation including: - gaze stabilization - dual-task balance training - spatial navigation - agility training Data from another fifteen SMs, who will not go through the multisensory rehabilitation regimen and will receive supervised cardiovascular exercise, will be used as the control group. Researchers will compare the Praxis and Control group to determine if the Praxis group shows improvement over the control group with respect to the military-relevant behavioral performance outcomes and patient-reported symptom scores after the end of the rehabilitation.

NCT ID: NCT06070025 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

Impact of Pre-Military Life Experiences/Exposures on Active-Duty Service Members' Psychological Health

Start date: January 22, 2023
Phase:
Study type: Observational

The goal of this observational study is to learn about the impact of historic and current Traumatic Brain Injuries on a Marine Battalion. Its main objectives are: - Establish individual mental and physical performance profile and brain health baseline in Infantry Marines - Develop predictive models to identify early signs of mental and/or physical degradation that can help predict "red-line" behavioral events and degradation in brain health. - Gather insights that will lead to developing personalized, evidence-based interventions to restore mental and physical performance. - Increase warfighter self-knowledge and personal awareness to monitor and maximize performance. Participants will wear wear smart watches and analyte sensors to track their real time physiological and sleep measures and complete subjective and psychological measures in a custom research app.

NCT ID: NCT05942638 Enrolling by invitation - Clinical trials for Brain Injuries, Traumatic

Longitudinal Assessment of Post-concussion Driving in Young Adults

LAPDYA
Start date: August 29, 2023
Phase:
Study type: Observational [Patient Registry]

Upwards of 3.8 million concussions occur annually in the United States. Driving is a highly complicated activity that requires visual, motor, and cognitive skills, which are commonly impaired after concussion. Yet, the time course of post-concussion driving impairment has not been characterized. There is a critical need to 1) determine when concussed individuals should return to driving and 2) identify the key concussion assessment predictors of readiness to return to driving. In the absence of formal recommendations, impaired concussed drivers are at risk to themselves and others on the road. The first specific aim is to compare simulated driving between concussed individuals and non-concussed yoked matched controls across five longitudinal timepoints (pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance) and daily naturalistic driving from day 2 to day 9. Driving recommendations must be appropriate and necessitated by concussion impairments, since excessively strict recommendations wrongfully strip concussed patients of their independence and may dissuade individuals from seeking medical care. The second specific aim is to identify widely used concussion assessment outcomes that predict simulated driving performance among concussed individuals throughout concussion recovery. To address these aims, 100 concussed and 100 yoked matched control young adult college athletes will complete a simulated driving assessment and a robust concussion assessment battery at pre-injury baseline, day 2, day 4, asymptomatic, and unrestricted medical clearance. Naturalistic driving (measured with in-car global positioning systems) will be captured from day 2 to day 9 (7 days total). This study will determine the acute and subacute time course of post-concussion driving impairment and determine key predictors of post-concussion driving performance. Results from this innovative approach will have a broad and positive impact that will improve the safety of both concussed individuals and the general population, guide the practices of health professionals, inform the future work of researchers, and substantiate the work of policy-makers by providing evidence-based recommendations for managing post-concussion driving.

NCT ID: NCT05929833 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)

Start date: January 26, 2024
Phase: N/A
Study type: Interventional

Despite racial/ethnic disparities in outcomes for younger adults with traumatic brain injury (TBI), there are no U.S. standards for TBI transitional care for patients discharged home from acute hospital care. To enhance the standard of care, the investigators will examine the efficacy of the existing intervention named BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery), a culturally-tailored, patient- and family-centered TBI transitional care intervention, compared to usual care, among younger adults with TBI and families. The knowledge generated will drive improvements in health equity for younger adults with TBI of various races/ethnicities and families, resulting in improved health of the public.

NCT ID: NCT05917665 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

Early Digital, Analyte and Neurologic Biomarkers of Acute and Chronic Brain Injury and Recovery in CQT Instructors

Start date: June 2024
Phase:
Study type: Observational

Repetitive blast exposure has been shown to lead to more severe neurobehavioral impairments versus a single exposure. Blast-induced Traumatic Brain Injury (TBI) can lead to short- and long-term adverse outcomes Even mild brain injuries can impair neurocognitive performance, and repeated injuries can amplify negative outcomes. Service members with repeated exposure to low-level blasts as a necessary part of their job or training display altered neural activity during a memory task that is paralleled by a reduction in accuracy on neurocognitive memory tasks. As a result, it is important to monitor service members that are exposed to multiple blast-generated mTBIs to allow the earliest identification of acute or chronic brain and body insult and provide individualized measures of time to recovery. While TBI is clinically diagnosable, the methods of diagnosis have up to now been typically expensive and immobile, and treatments and interventions sparse. The investigators will conduct a longitudinal assessment of mTBI brain biomarkers by collecting repeated measures of FDA approved mTBI brain injury biomarkers, correlated with sound and blast exposure, as well as continuous monitoring through smart watches (activity, sleep, biometrics, calorie expenditure, balance) and analyte data through analyte sensors (glucose, lactate, ketones). Study data will be organized into categories and presented to participants daily within the application and will be securely stored within the application. At the completion of the study, participants will be provided with the study data digitally within the mobile application and study data will also be provided to the credentialed unit medical provider to enable it to be ported to the participants' electronic medical record. This study will create a continuous record of blast overpressure and sound exposures and correlate those to the participants health state over the course of several 9-week courses. This will enable an assessment of individualized susceptibility to brain injury as well as providing novel data on time to recovery. The investigators hope to develop dynamic and accurate risk profiles that are individual and will lead to further understanding of how to protect participants from mTBI (mild TBI) events.

NCT ID: NCT05911139 Enrolling by invitation - Anesthesia Clinical Trials

Influence of General Anesthesia on the Dynamic Changes in Brain Damage Markers During and After Craniosynostosis Operations in Infancy

TAnBrainDam
Start date: October 1, 2022
Phase:
Study type: Observational [Patient Registry]

The issue of anesthetics neurotoxicity is one of the most discussed topics in pediatric anesthesiology, thus it opens the question of the safety of commonly used anesthetics in the pediatric patient. Preclinical studies have shown that anesthetics can have a toxic effect on the maturing brain of pups and cause cognitive impairment. In human medicine, the influence of anesthetics is studied by monitoring the psychomotor development of children who have undergone surgery under general anesthesia. Some work deals with laboratory evidence of brain damage due to general anesthesia, but none of the work deals with the observation of markers of brain damage in infants. The aim of this work is to examine the dynamics of changes in the concentrations of selected markers of brain damage in craniosynostosis operations under general anesthesia in infants in order to optimize perioperative management and the correct timing of surgery.

NCT ID: NCT05864677 Enrolling by invitation - Critical Illness Clinical Trials

Cerebrolysin in Prevention of Postoperative Delirium in Cardiac Surgery

Cereb-POD
Start date: January 15, 2023
Phase: N/A
Study type: Interventional

Postoperative delirium (POD) and postoperative neuropsychological dysfunction are frequently noted in critically ill patients undergoing elective or emergency surgery and treated in the intensive care unit (ICU). Delirium is a serious complication that prolongs hospital stay and contributes to poor outcomes and increased risk of death. The pathomechanisms of delirium are still not very well recognized and there are several theories that seem to explain it. The most important pathomechanisms of delirium are associated with cerebral ischaemia, disorders in acetylcholinergic system, disorders in neuronal plasticity and oxidative stress. Cerebrolysin, a mixture of various peptides obtained from the structural proteins of the pig's brain, possesses strong antioxidative and neuronal protective properties. Cerebrolysin is recommended to treat patients with dementia, after cerebral ischemia and after brain trauma. It has been documented that Cerebrolysin reduces the severity of secondary brain damage after ischemia, improving neuronal plasticity and then cognitive function, and reducing severity of oxidative stress. Based on these properties it can be speculated that Cerebrolysin may reduce the risk of postoperative delirium in patients undergoing elective surgery, which are associated with a high risk of postoperative delirium.

NCT ID: NCT05825027 Enrolling by invitation - Clinical trials for Mild Traumatic Brain Injury

Risk Stratification in Children With Concussion

RSiCC
Start date: May 23, 2023
Phase:
Study type: Observational

This project will measure concussion symptoms, biological markers, and academic and social factors across the first year postconcussion to develop a model that enables early identification of and symptom management for children at higher risk for persistent postconcussive symptoms. Findings will provide novel insights into the longer-term effects of concussion on children's physical, psychological, and social well-being and support the development of personalized healthcare and school-based plans to reduce disparities in children's ability to return-to-learn and -play and improve postconcussion quality of life.

NCT ID: NCT05823766 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)

Start date: March 1, 2022
Phase:
Study type: Observational

The overarching goal of this study is to improve understanding of the long-range natural history of TBI and post-traumatic epilepsy (PTE) by extending follow-up of a previously enrolled cohort (TRACK-TBI) beyond the first 12 months after injury.