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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT05091970 Active, not recruiting - Clinical trials for Mild Traumatic Brain Injury

Symptom-Targeted Approach to Rehabilitation for Concussion

STAR-C
Start date: November 10, 2021
Phase: N/A
Study type: Interventional

Throughout the course of the wars in Iraq and Afghanistan, more than 250,000 service members sustained traumatic brain injuries, mostly characterized as mild traumatic brain injuries (mTBI) or concussions. While most with mTBI recover over days to weeks, a significant percentage continue to experience post-concussive symptoms such as headaches, cognitive difficulties, and dizziness for months to years. As a result, treatment of post-concussive symptoms after mTBI is of significant importance in the Department of Defense and Veterans healthcare systems. Several studies have shown that cognitive rehabilitation can be effective for individuals with mTBI, including Service Members and Veterans with post concussive symptoms. Cognitive rehabilitation is a type of treatment in which patients work with a therapist to improve everyday memory and thinking skills and develop strategies to reduce the impact of cognitive difficulties in their everyday lives. While these treatments have great potential benefits, protocols studied to date are time intensive, requiring up to 60 hours of treatment. These time demands are impractical for many Service Members and Veterans, and place a time-burden on clinics providing the treatment. The current study proposes to identify key ingredients of an evidence-based cognitive rehabilitation protocol to develop a streamlined version that is feasible and acceptable to Service Members and Veterans. This briefer protocol will increase the number of Service Members and Veterans who can access treatment. To accomplish this goal the investigators will first spend six months analyzing manualized treatments from a successful cognitive rehabilitation intervention developed for Service Members. The investigators will analyze manuals using a framework developed to identify active ingredients in rehabilitation. Based on those results the investigators will develop a manualized streamlined treatment protocol, which the investigators will deliver to 25 Service Members and 50 Veterans over 18 months in person or via telehealth. The investigators will determine feasibility and acceptability of this intervention, and collect preliminary efficacy data. The project addresses access to therapy services and enhanced treatment compliance, a key barrier to participation in cognitive rehabilitation by Veterans and Service Members with TBI. Additionally, although this study focuses on Service Members and Veterans with mTBI, the investigators expect that this streamlined intervention can also be translated to civilian populations with mTBI.

NCT ID: NCT05090007 Recruiting - Clinical trials for MTBI - Mild Traumatic Brain Injury

Imaging of Injury Mechanism and Interaction of Intestinal Bacteria in Children With Mild Traumatic Brain Injury

Start date: October 25, 2021
Phase:
Study type: Observational

Traumatic brain injury (TBI) is the leading cause of disability in children and young adults. Children with moderate to severe TBI are typically at risk of poor functional outcome in terms of neurocognitive impairment and behavior problems. Neurocognitive impairments include deficits in attention and working memory, learning and memory, and executive functioning, whereas behavior problems include anxiety, depression and aggression. Neuroimaging techniques based on multi-modal magnetic resonance image (MRI) can detect the structural and functional brain abnormalities objectively and sensitively. Recent evidence indicates that even after mild TBI, children with risk factors for intracranial pathology are at risk of poor neurocognitive and behavioral outcome.Meanwhile, recently, the concept of "gut-brain axis" has been proposed and hint gut microbiota could shape the brain. Some studies have emphasized that human gut microbiota plays an important role in the pathogenesis and development of TBI. However, how the gut affects the brain in patients with TBI is unclear. Thus, combining analysis of neuroimaging and "gut-brain axis" will provide more information for finding the risk factors and imaging diagnostic markers of brain impairment in TBI. It will also helpful for explaining the underlying mechanisms of brain impairment in TBI, providing an objective basis for clinical diagnosis and prediction of the prognosis.

NCT ID: NCT05086419 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Sub-symptom Threshold Aerobic Exercise After Mild Traumatic Brain Injury

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

This Randomized Controlled Trial (RCT) will explore the effect of sub-symptom threshold aerobic exercise on persistent post-concussion symptoms and exercise intolerance in patients with mild Traumatic Brain Injury (TBI). The hypothesis is that sub-symptom training will reduce the symptom pressure, normalize exercise tolerance, reduce patient-specific activity limitations and improve health-related quality of life. To improve the chances of conducting a high-quality RCT, a feasibility trial will be completed prior to the definitive RCT.

NCT ID: NCT05084352 Recruiting - Clinical trials for Traumatic Brain Injury

Real Time Vital Sign Assessment to Predict Neurological Decline After Traumatic Brain Injury

RAPID-TBI
Start date: March 29, 2021
Phase:
Study type: Observational

This study will look to validate predictive algorithms developed in a previous study where we collected relevant data from trauma registry and after using advanced signal-processing and machine-learning, determined prediction scores regarding neuroworsening and other outcomes following traumatic brain injury.

NCT ID: NCT05081063 Completed - Clinical trials for Traumatic Brain Injury

Low-Titer O Positive Whole Blood Versus Component Therapy for Emergent Transfusion in Trauma Patients

Start date: March 5, 2022
Phase: Phase 3
Study type: Interventional

Adult male patients brought to the emergency department as Level A trauma activations who are receiving emergency blood transfusion. Objectives 1. Evaluate PRBC equivalents transfused in each group in the first 24 hours (Primary outcome) 2. Evaluate total transfusion in each group in the first 24 hours (Secondary Outcome) including breakdown by FFP equivalents, platelet units, and cryoprecipitate 3. Evaluate 6 hour, 24 hour, and hospital mortality (Secondary Outcome) 4. Evaluate ICU outcomes in each group

NCT ID: NCT05075239 Completed - Clinical trials for Statistical Analysis of Traumatic Brain Injury Victims

Morbidity and Mortality in Solo Adult Traumatic Brain Injury Patients in Minia University Hospital

Start date: September 15, 2021
Phase:
Study type: Observational

Tracking post-traumatic brain injury sequale

NCT ID: NCT05065528 Withdrawn - Concussion, Mild Clinical Trials

Mag Con: Efficacy of Oral Mag. in Acute Concussion in Adolescents

Start date: August 30, 2021
Phase: N/A
Study type: Interventional

This randomized trial will compare the clinical efficacy of adding oral magnesium oxide to acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury using the Post-Concussion Symptom Severity Score Index.

NCT ID: NCT05065450 Recruiting - Epilepsy Clinical Trials

Amygdala Memory Enhancement

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The objective is to understand how amygdala activation affects other medial temporal lobe structures to prioritize long-term memories. The project is relevant to disorders of memory and to disorders involving affect and memory, including traumatic brain injury and post-traumatic stress disorder.

NCT ID: NCT05065099 Recruiting - Concussion Clinical Trials

Online Treatment Recovery Assistance for Concussion in Kids

OnTRACK
Start date: February 2022
Phase: N/A
Study type: Interventional

The investigators propose to develop a software platform, OnTRACK (Online Treatment Recovery Assistance for Concussion in Kids), for children and adolescents recovering from concussion or mild traumatic brain injury (mTBI). The platform includes a mobile application (app) for the patients and their care team (parents, teachers, coaches, etc.), a database server, and a decision support dashboard for healthcare providers. The OnTRACK app prompts the patient to report post-concussion symptoms across recovery in two distinct but equally important ways: a weekly cross-recovery graded symptom ratings to track overall recovery progress, and short-term daily dynamic exertional symptom responses to guide tolerable daily activity. Teachers and parents and other authorized members of the patient care team also report patient progress when prompted. Beyond symptom reporting, the app provides access to education in the form of short multimedia clips that cover various topics related to concussion recovery based on the PACE (Progressive Activities of Controlled Exertion) model. Using several large existing datasets on recovery trajectories, the serial symptom reports indicate (a) level of symptom severity, change over time, and whether recovery is following a typical or atypical pattern. The healthcare provider is regularly updated regarding recovery progress and, if an atypical pattern is reported, he/she receives an alert to assess further and consider referral for additional treatment. To guide daily recovery, OnTRACK uses empirically-derived algorithms to determine when the level of symptom exacerbation reaches a certain threshold, delivering an alert to the healthcare provider who can give feedback to the child to manage daily activities and reduce disruptive symptoms. The primary goal of the OnTRACK system is to afford the healthcare provider, patient, and family greater confidence with data-driven decisions upon which to follow evidence-based treatment guidelines and to improve communication between family and provider.

NCT ID: NCT05062148 Withdrawn - Clinical trials for Traumatic Brain Injury

Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery

Start date: September 2021
Phase: N/A
Study type: Interventional

This research is being done to understand the role of different recovery methods in healing time after athletic or sports related concussion.