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Brain Injuries clinical trials

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NCT ID: NCT04951453 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Systemic Nitrosative/Oxidative Stress in Patients With Acute Brain Injury

NOX
Start date: August 18, 2021
Phase:
Study type: Observational

Acute brain injury due to traumatic brain injury (TBI), intracerebral haemorrhage (ICH), and aneurysmal subarachnoid haemorrhage (SAH) carries a high morbidity and mortality, in part due to the development of secondary brain injury. The mechanisms behind secondary brain injury are incompletely understood, but oxidative/nitrosative stress and disturbances in the metabolism of the vasodilator nitric oxide (NO) are believed to be involved. The aim of the present study is to characterise systemic changes in markers of oxidative/nitrosative stress and NO metabolism in the early phase after acute brain injury, and to examine their relationship to clinical course, neurological outcome, and mortality.

NCT ID: NCT04949607 Completed - Clinical trials for Brain Injuries, Traumatic

Traumatic Brain Injury and the Gut Microbiome

Start date: July 28, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether administration of a prebiotic, inulin, can improve the symptom complex associated with traumatic brain injury and whether inulin administration can alter the bacteria that live in the gut.

NCT ID: NCT04945213 Recruiting - Clinical trials for Brain Injury Traumatic Severe

Biperiden Trial for Epilepsy Prevention

BIPERIDEN
Start date: January 10, 2023
Phase: Phase 3
Study type: Interventional

One of the most important neurological consequences following Traumatic Brain Injury (TBI) is the development of post traumatic epilepsy (PTE). Nevertheless, there is still no effective therapeutic intervention to reduce the occurrence of PTE. In previous studies with animals models of epilepsy, the biperiden decreased the incidence and intensity of spontaneous epileptic seizures besides delaying their appearance. The aim of this study is the evaluation of biperiden as antiepileptogenic drug to prevent PTE and also the determination of side effects, evaluating its cost-effectiveness in patients with moderate and severe TBI.

NCT ID: NCT04943835 Completed - Clinical trials for Acquired Brain Injury

Validity of a Test of Functional Cognition in Persons With Acquired Brain Injury

Start date: January 12, 2017
Phase:
Study type: Observational

The purpose of this study is to test the validity of the Weekly Calendar Planning Activity (WCPA), a test of functional cognition in persons with acquired brain injury. We will formally examine the utility, baseline profile and validity of the WCPA with adults ages 21 and above with acquired brain injury for both the WCPA 17 and WCPA 10 versions.

NCT ID: NCT04939688 Recruiting - Clinical trials for Head Injuries, Closed

Concordance Between Ultra-low Dose (ULD) and Standard Dose CT Scans in the Search for Traumatic Brain Injury

ULD-CRANE
Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The aim of this research is to evaluate the diagnostic concordance of ultra low-dose and standard dose reconstructed computed tomography acquisitions using the ADMIRE algorithm to search for intracranial lesions - both hemorrhagic and bone lesions - in trauma patients at the emergency department. The study will also evaluate the diagnostic performance of the two protocols, as well as the speed of image reading. For the first time, acquisitions ≤ 10 mGy (lower value than reported in the literature) will be performed with top-of-the-range scanners available in the emergency room to search for intracranial lesions. These scanners are equipped with the latest generation of ADMIRE iterative algorithms.

NCT ID: NCT04936360 Completed - Brain Injuries Clinical Trials

Evaluating the Care Burden of Caregivers of Patients With Brain Injury and Determining the Influencing Factors

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

Acquired brain injury is a general term including trauma due to head injury or postsurgical damage, vascular accident such as stroke or subarachnoid hemorrhage, toxic or metabolic cause such as hypoglycemia, cerebral anoxia, and infection or inflammation. However acquired brain injury leaves survivors with a considerable burden of physical, cognitive, emotional,behavioural and psychosocial limitations,these individuals often require healthcare, supervision, and support from professional or informal caregivers in some or all of their lives. Therefore, this study have two primary aims: (1) to conclude the level of caregiver's life satisfaction and strain; and (2) to determine the factors predicting strain among the caregivers. İnvestigators believe this study can add to the literature and create awareness on the current state of caregiver's well-being in this part of the world.

NCT ID: NCT04935866 Recruiting - Anemia Clinical Trials

Optimal Brain Oxygenation in Neurologic Intensive Care Unit : The NeurO2 Study

NeurO2
Start date: May 7, 2021
Phase:
Study type: Observational

The NeurO2 study is a multicenter observational study looking at NIRS monitoring in neurocrocritically ill patients during the acute phase of care following an acute brain injury. The study is nested within the HEMOTION Trial and the SAHaRA Trial

NCT ID: NCT04935697 Recruiting - Clinical trials for Traumatic Brain Injury

Non-invasive Vagal Neurostimulation (nVNS) for Traumatic Brain Injury (TBI)-Induced Acute Respiratory Distress

Start date: August 4, 2021
Phase: N/A
Study type: Interventional

This is a prospective, randomized, two-arm, controlled 30-day investigational pilot trial using the gammaCore Sapphire S non-invasive vagus nerve stimulation (nVNS) device + standard of care (SOC) in newly-hospitalized patients with mild-to-moderate traumatic brain injury (TBI) to prevent the progression towards immunokine storms, systemic inflammatory response syndrome (SIRS), severe respiratory distress, and requirement for invasive mechanical ventilation, and death, when compared to SOC alone (the control arm).

NCT ID: NCT04933448 Recruiting - Clinical trials for Traumatic Brain Injury

Ketogenic Diet Following Moderate to Severe Pediatric Traumatic Brain Injury

Start date: May 16, 2022
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the feasibility and safety of using the ketogenic diet (KD) in children who sustained moderate to severe traumatic brain injury (TBI). The secondary objective is a preliminary evaluation of the outcomes of children who have had the standard of care plus the KD, compared to those with standard of care alone. Outcome measures for the secondary objective will include: need for ventriculoperitoneal shunt, duration of unconsciousness, need for any type of craniotomy, duration of post-traumatic amnesia, acute hospitalization length of stay, and cognitive and motor function at 12 months after injury. If this study demonstrates feasibility and safety, the information related to outcomes will be used to inform the planning of a future, larger, randomized study of the efficacy of the KD in children and adolescents with TBI. Specifically, this information will be used to assist with sample size calculations for this future study.

NCT ID: NCT04932096 Recruiting - Critical Illness Clinical Trials

Sleep Management And Recovery After Traumatic Brain Injury in Kids: Pilot Intervention of Melatonin

SMARTKids
Start date: January 2, 2023
Phase: Phase 2
Study type: Interventional

Sleep wake disturbances compound recovery in over half of pediatric traumatic brain injury survivors, leading to impaired quality of life, and few effective interventions exist to treat this important morbidity. Therefore, this study will conduct a randomized controlled trial evaluating a melatonin intervention started during hospitalization and continued after discharge compared to placebo. The trial will investigate if this intervention is feasible, acceptable, and effective at reducing sleep wake disturbances as measured on the Sleep Disturbances Scale for Children 1-month after hospital discharge. Participants will be randomly assigned to receive the intervention (melatonin) or to the control group (placebo) with a goal of equal numbers of participants in each group and all will receive sleep education. Participants will be followed closely after consent and outcomes will be assessed at hospital discharge, and 1-month. Outcomes will focus on feasibility (ability to recruit patients into the trial) and acceptability (patient safety and satisfaction), but will also assess the effectiveness of the intervention to reduce sleep disturbances after discharge. The investigators will assess sleep using questionnaires and actigraphy (watch-like activity monitors). Exploratory outcomes will include global health outcomes.