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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT04974060 Recruiting - Clinical trials for Traumatic Brain Injury

Treatment of Spontaneous Hyperventilation With Remifentanil in Traumatic Brain Injury Patients

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

Spontaneous hyperventilation is common in severe traumatic brain injury patients and correlates closely with poor outcomes. How to treat this pathological condition remain unsolved. Remifentanil is a frequently used short-acting opioid, has the potent side-effect of dose-dependent respiratory inhibition. Specifically, it prolongs the expiratory time only and does not influence the respiratory drive. Among the safety range, the investigators will determine an ideal dose of remifentanil to maintain PaCO2 between 35 to 45 mmHg. The investigators will monitor the cerebral blood flow of the middle cerebral artery and the internal carotid artery to validate cerebral perfusion improvement.

NCT ID: NCT04972786 Recruiting - Clinical trials for Traumatic Brain Injury

Noninvasive Modulation of Motivational Brain Regions in Healthy Volunteers

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

21 healthy control participants will be recruited. On Day 1 they will complete reward-guided decision making tasks and questionnaires followed by a functional magnetic resonance imaging (fMRI) scan. On Days 2 and 3 they will receive repetitive transcranial magnetic stimulation (rTMS) targeting a specific part of the brain called the dorsal anterior cingulate cortex (dACC) or sham stimulation, and will then repeat a subset of the same decision making tasks and fMRI sequences. If brain stimulation modifies decision making and dACC activity, it could represent a novel way of treating patients with neural circuit deficits that impede motivated behavior. Of particular relevance to the current trial, this rTMS study will run in parallel with a study of apathy (i.e., diminished motivation) in patients with traumatic brain injury (TBI), with the goal of eventually leading to a patient-centered trial of rTMS treatment for this disruptive neuropsychiatric symptom.

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: 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: 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.

NCT ID: NCT04930146 Recruiting - Clinical trials for Traumatic Brain Injury (TBI)

Functional Recovery Effect of Bloodletting Puncture at Jing-well Points on Acute Brain Injury Patients

Start date: June 8, 2021
Phase: N/A
Study type: Interventional

Traumatic brain injury (Traumatic brain injury, TBI) can be derived from various forms of injury, including blunt trauma, penetrating or acceleration/deceleration force caused by head injury.There are some study data show that acupuncture treatment has a superficial effect on the prognosis of traumatic brain injury and can limit the progression of secondary brain injury, but the effect of early bloodletting at the Jing-points on TBI patients still unknown. In our study, the investigators have proposed a randomized, controlled study design and plan to evaluate the efficacy and safety of Jing-point puncture to improve consciousness and neurological function in patients with TBI. In addition, an objective meridian instrument analysis was added to analyze the energy distribution in the meridian of TBI patients.

NCT ID: NCT04928534 Recruiting - Clinical trials for Chronic Traumatic Encephalopathy

Cohort Study of Blood Biomarkers for TES

Start date: May 1, 2021
Phase:
Study type: Observational

In this study, high-throughput screening and multi-omics (transcriptomics and proteomics) joint analysis technology will be employed to explore potential CTE/TES biomarkers (RNA and protein) in blood and its exosomes. Thereafter, these biomarkers will be combined with the reported TBI biomarkers to create a novel set of CTE/TES molecular diagnostic signatures. The findings may open a new avenue for the clinical diagnosis of the disease and the future research on its therapeutic strategy.