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Traumatic Brain Injury - ClinicalTrials.gov

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Last Updated: 18 May 2022

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Neural Basis of Decision Making Deficits in Traumatic Brain Injury

Objectives: Quantify differences in results on a decision-making task for TBI patients and healthy volunteers; determine whether baseline data of mesocorticolimbic network structure and function predict subsequent decision-making success in both TBI patients and healthy volunteers; and Determine if facilitatory transcranial direct current stimulation, which is a mesocorticolimbic network region vitally involved in decision-making following TBI; and Determine whether decision-making after TBI; Endpoints: Primary Endpoint: Both Experiment 1 and 2's primary outcome measure is their results in a computerized decision-making task. Multimodal data fusion modeling will be used to determine the correlation between baseline mesocorticolimbic network functionality and decision-making task results in a unified state-space framework, as well as the ability of these network capabilities to predict inter-individual variations in the effects of tDCS on decision-making task success.

Source link: https://clinicaltrials.gov/ct2/show/NCT02169310


Problem Solving Training for Care Partners of Adults With Traumatic Brain Injury

During Inpatient Rehabilitation Care partners of adults with Traumatic Brain Injury, adults with TBI experience significant burden and emotional pain, as well as a need for more resources and skills to deal with the transition from hospital to home, according to North TX's Module Project: Problem Solving Training for Adults with Traumatic Brain Injuries. During inpatient recovery, the investigators will assess the likelihood and effectiveness of Problem Solving Training for care partners to reduce burden and depressive symptoms, as well as better cope in the crucial transition from inpatient rehabilitation to the community. paraphrasedoutput:14 Hence, there is a strong need to ensure health and care partners of adults with TBI with the necessary skills to navigate this difficult transition from hospital to home, as shown by self-management training for adults with TBI. Aims 1: To determine the possibility of delivering Problem Solving Training to care partners of individuals with TBI inpatient rehabilitation, see the following objectives. Specific Aim 2: To determine the success of care partners of individuals with TBI-specific education relative to TBI-specific education alone for improving the outcomes of care partners of individuals with TBI. PST+ Education vs Education alone during an inpatient rehabilitation stay for people with TBI. Method: The investigators will perform a controlled trial of PST + Education vs. Education alone. Description of Intervention: The intervention team's care partners will be provided with PST and TBI-specific instruction. Aim 1: Assessments: The investigators will track number of PST sessions completed, if a minimum of 3 sessions were completed, as well as care partner satisfaction, as well as care partner satisfaction. At 1-month and 6-months post-discharge, the investigators will compare differences in PST+Education, depressive symptoms, and communication skills, including alcohol use, at Aim 2 and beyond. If there are group differences, the investigators will perform formal statistical analysis to find potential confounding variables resulting from initial group differences and adjust for these variables appropriately. When appropriate, the investigators will use intent-to-treat techniques to determine the differences in each outcome measure between PST Intervention vs. Education groups at a one-month follow-up using t-tests or Mann Whitney U tests as appropriate. The investigators will use baseline data from all participants and qualitative factor analysis to determine second-order factors in our study as a way to reduce data and analyze total scores within the second-order factors. The investigators' previous research conducted PST to 77 care partners of adults with TBI who had TBI via telephone beginning one week post-discharge. The investigators' previous research design had about ten sessions, with eight sessions as a goal. PST+ Education is expected to be more beneficial than Education alone in reducing caregiver burden and depressive symptoms and increasing positive coping among care partners, according to the investigators. However, there are no studies establishing whether PST delivery to care partners is appropriate and effective during inpatient rehabilitation.

Source link: https://clinicaltrials.gov/ct2/show/NCT03739450


Effects of Rapid-Resisted Exercise on Ambulatory Adults With Traumatic Brain Injury

TBI-related motor, neurobehavioral, and brain imaging findings will be compared by healthy volunteers and ambulatory adults with traumatic brain injury TBI; and two research the effects of rapid, reciprocal arm and leg exercises with an elliptical trainer on high-level motor coordination and balance, as well as cognitive and cognitive functioning in people with TBI. Compared to a similar period of time when they were not participating in training, we suspect that even highly functioning adults with TBI will have lower scores on all measures than controls; exercise will result in significant improvements in motor control and stability, and cognitive and cognitive function; and neurobehavioral and cognitive function can also improve. The study will include 80 adults with TBI, 20 with TBI, and 20 healthy volunteers. Healthy controls are determined by a single evaluation that incorporates motor, neuropsychological, and brain imaging tests. Participants with TBI will perform three visits with the same motor, neuropsychological, and brain imaging assessments as the healthy controls. With a strong emphasis on maintaining a fast pace, the exercise unit will be an elliptical trainer that exercises the legs and arms. Measures: With 3D motion capture & EMG, the Smart Balance Measurement System, and the High Level Mobility Assessment Tool Hi-MAT, users' success on challenging motor and balance tasks will be evaluated. Cortical linkage will be determined using resting state functional connectivity magnetic resonance imaging MRI and Diffusion Tensor Imaging DTI, which assesses white matter tracts. With fMRI, cortical activation patterns during imagined walking can be quantified.

Source link: https://clinicaltrials.gov/ct2/show/NCT01175993


Correction of Platelet Dysfunction Following Traumatic Brain Injury in Geriatric Patients

Platelets become dysfunctional and are no longer able to support platelet formation following traumatic Brain Injury, even without platelet inhibitor drugs. Patients with platelet dysfunction following brain injury are expected to transfuse platelets in patients with platelet dysfunction following brain injury. The Carolinas Medical Center's clinical research is to transfuse platelets in patients with platelet dysfunction following brain injury. The new research is looking at the effects of transfusion on platelet dysfunction and patient outcomes. Hence, the ability of cytochrome c to correct deficit in ex vivo platelets from patients with Traumatic Brain Injury will be investigated.

Source link: https://clinicaltrials.gov/ct2/show/NCT03182946


Retraining Neural Pathways Improves Cognitive Skills After A Mild Traumatic Brain Injury

The results from a pilot study of 4 mTBI subjects will be extended to a much larger sample of mTBI subjects. This report will compare PATH preparation, featuring dim gray stripes moving left or right to launch the parvocells in the ventral stream, with sham education, displaying vibrant stationary colors tilted left or right to ignite the parvocells in the ventral stream, with an N-Back Working Memory task to activate dorsal lateral Cortex. Following a mTBI, we believe that PATH training improves working memory, processing speed, and attention more than Sham or N-Back WM training. Following both PATH and Sham training, memory exercises will be followed by cognitive exercises to enhance cognitive skills, improving cognitive function, and a complementary program consisting of 15 minutes of working memory practice, each with the correct sequence of digits, from 5 digits up to 10 digits will be completed in 15 minutes. Two months after intervention neurotraining, determining whether cognitive improvements are maintained over time can be determined by assessing whether mTBI subjects improve on cognitive control and neuropsychological measures of cognitive function. 1 In addition, characterize individual differences in cognitive function in mTBI patients, as well as 2 Determine the role of individual differences at initial assessment and in change following training for different subpopulations.

Source link: https://clinicaltrials.gov/ct2/show/NCT03655782


Evaluation and Diagnosis of Potential Research Subjects With Traumatic Brain Injury (TBI)

This screening and registry procedure is intended to facilitate subject recruitment for the Center for Neuroscience and Regenerative Medicine sponsored clinical trials on traumatic brain injury in the National Institutes of Health and other CNRM sites. Other approved CNRM protocols may continue to recruit participants directly into their respective studies and may refer to this research. The aim of this project is to establish a subject recruitment database that will hold preliminary data on research subjects that are interested in and potentially eligible for current and future CNRM sponsored research protocols. The effectiveness of the recruitment methods used in this research will be determined to determine the most effective outreach strategies and recruitment methods for the enrollment of TBI or post-concussive study participants. Plan Details This paper describes an initial research visit conducted in one of two ways: at the NIH Clinical Center or at the participating site. Subjects enrolled acutely and/or at a participating site may also be able to complete an additional visit to the NIH CC after their initial visit. The subject will be referred to appropriate CNRM protocols for further protocol-specific screening prior to enrollment, or advised that he is not eligible for any other ongoing CNRM research at this time, based on the data gathered during the initial study visit.

Source link: https://clinicaltrials.gov/ct2/show/NCT01287156


Evaluation, Pathogenesis, and Outcome of Subjects With or Suspected Traumatic Brain Injury

Population One thousand male and female adult subjects with a history of recent head injury with or suspected non-penetrating acute TBI will be included. Purpose This is a prospective review of patients with acute and/or suspected non-penetrating acute traumatic brain injury. Patients presenting to the emergency department or trauma service at participating hospitals with a history of recent head injury will be followed during their hospital stay and after discharge using radiological, hematological, clinical, and functional outcome measures. If subjects consented to this option on the informed consent, data gathered under this research may be shared anonymously with other researchers without identifiers. According to this protocol, data and samples collected under this protocol and other protocols that enable data exchange will be combined for secondary analysis under this protocol.

Source link: https://clinicaltrials.gov/ct2/show/NCT01132937


Effect of Hyperbaric Oxygen on Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury

A total of 100 people will be randomly assigned to either an intervention arm: 50 participants were exposed to > 99. 9% oxygen at 2. 5 atmosphere absolute for 60 minutes in 40 minutes over 40 treatments, or sham-treatment arm: 50 participants were exposed to an oxygen and pressure composition similar to breathing atmospheric air for 60 minutes for 60 minutes over 40 treatments. This research is designed to determine whether hyperbaric oxygen enhances neuropsychological stability and reduces symptoms in adults with persistent post-concussive disease following mild traumatic brain injury.

Source link: https://clinicaltrials.gov/ct2/show/NCT05173818


Effect of Aerobic Exercise Training on Cardiorespiratory Fitness in Patients With Traumatic Brain Injury

The aim of this exploratory study is to provide clinical trials and trials on the use of aerobic exercise training as an adjunct to improving cardiorespiratory endurance in patients with traumatic brain injury. We predict that 1 AET will raise both cardiovascular endurance and fatigue severity 2nd mood at first in response to AET, but that mood reactivity will decline at some point during the procedure, but that overall cognitive performance will improve with AET. Outcome Measures AET-induced change in cardiorespiratory fitness as measured by peak oxygen consumption is the key success metric and will be determined by pulmonary gas exchange analysis during treadmill exercise tolerance testing. A submaximal, continuous work rate test will also be used to determine the cardiorespiratory system's ability to satisfy the energy needs of jobs during time VO2 on-kinetics. The Fatigue Severity Scale FSS is the most commonly used measurement device for the fatigue outcome variable. The Medical Outcomes Study 36-Item Short Form MMM-76SF, Becks Depression Inventory BDI, The Pittsburgh Sleep Quality Index PQI, the International Physical Activity Questionnaire IPAQ, and the Profile of Mood States Short Form POMS-SF. The time variable for mood change is the week of onset for significant improvement in mood reactivity, according to the author.

Source link: https://clinicaltrials.gov/ct2/show/NCT01294332


Safety and Cognitive Effects of Acute Intermittent Hypoxia-Induced Neuroplasticity in Traumatic Brain Injury

The aim of this research is to determine if Acute Intermittent Hypoxia is safe to administer to medically stable chronic traumatic brain injury patients. Is AIH safe to give to TBI patients? These little AIH episodes that occurred for five days in a row can be safely tolerated without pathological consequences, according to recent research in humans with chronic spinal cord injury and stroke. According to the cumulative results, repetitive AIH can be safely used to determine whether it can improve neurobehavioral health in TBI patients without adverse side effects. We will deliver mild AIH to 16 patients on four separate days over the course of two to four weeks, beginning with normal oxygen levels and then gradually decreasing the oxygen levels over the next three sessions in this research. Our main goal is to determine whether it is safe to give mild AIH to chronic TBI patients with persistent functional impairments but who are clinically stable. We'll find out whether mild AIH administration has any post-session or cumulative effects post-study on memory and cognition, cortical stimulation, as determined by single-pulse Transcranial Magnetic Stimulation, or whether pre-study brain architecture or functional connectivity as determined by quantitative and resting-state functional magnetic resonance imaging predicts response to AIH as a secondary objective in this review. If no adverse effects were found in this review, no adverse effects of mild AIH were reported in this study, clinical trials using mild AIH alone or in conjunction with neurobehavioral therapy may determine whether AIH promotes functional growth after TBI.

Source link: https://clinicaltrials.gov/ct2/show/NCT04890639

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions