View clinical trials related to Brain Injuries, Traumatic.
Filter by:The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke, traumatic brain injury (TBI) and/or spinal cord injury (SCI). The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period. Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room. HandyMotion is a sensor-based training system that can connect to the TV set in the hospital room, enabling patients to access their therapy training program to practice rehab-oriented games and exercises ad libitum, at any time of the day.
Protocol Summary The present study was developed to better understand the effects and benefits of individualizing rehabilitative treatments based on subgroup classifications determined by a standardized clinical examination. The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control. The secondary aim is to evaluate the Pre and Post treatment state of the participants via a rapid advanced electroencephalography (EEG) when compared to the active control who will be provided the current standard form of therapy for persistent symptoms. The EEG changes will be compared to the standardized clinical examination findings as well as the RPQ. Sample Size: N= 50 Study Population Participants will be eligible for study participation if they meet the following inclusion criteria: 21-years and older; diagnosed with postconcussion syndrome; and have adequate language skills in English to read and take part in rehabilitation treatment program. Participants will be excluded should: they have an unremarkable or normal clinical examination; have a chronic infectious disease; uncontrolled hypertension; other neurological disorders (not attributed to their primary diagnosis); cancer treatment (other than basal cell carcinoma), craniotomy, or refractory subdural hematoma long-term use of psychoactive medications that would compromise their ability to comprehend and perform study activities; those with pacemakers or elevated cardiovascular risk; ongoing litigation surrounding their injury; have been diagnosed with a moderate or severe brain injury prior to enrolment; post-concussive symptoms persisting beyond 12-months. Study Design The investigators will be conducting a 12-week case-crossover randomized controlled trial. Participants will undergo 6-weeks of care in their respective streams. After 6-weeks, participants will undergo a re-examination. They will then crossover and undertake the alternative treatment for 6-weeks. At the end of 12-weeks, participants will undertake the endpoint examinations. Start Date: May 2023 End Date: September 2025 Primary Objective: The primary aim is to evaluate the response to individualized therapy on recovery, as measured by The Rivermead Post-concussion Symptoms Questionnaire (RPQ) and standardized clinical examination, when compared to an active control.
The use of serum biomarkers in the setting of the emergency department (ED) has been well characterized over the years as an adjunctive tool for the clinician in the setting of complex decision making. In this regard, the serum dosage of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1) has been evaluated in a series of successful multicenter prospective studies as a potentially useful marker of, respectively, glial and neuronal damage in the setting of mild traumatic brain injury (mTBI), which is defined as a brain injury (concussion) secondary to trauma with a GCS (Glasgow coma scale) score of 13-15. It seems that both markers are detectable in serum less than 1 hour after the traumatic event, with highest levels appearing at around 2 hours, and are capable of distinguishing between patients with traumatic brain injury from those without acute brain injury after trauma. Furthermore, they seem to possess a high negative predictive value for detection of intracranial injuries at head CT-scan as well as the need of neurosurgical intervention after head trauma. Mild traumatic brain injury is one of the most frequent chief-complaints for patients presenting to emergency departments worldwide. At present, head CT scan is the gold standard diagnostic test for the identification of potentially life-threatening intra-cranial injuries. Although effective in the identification of serious lesions which might require neurosurgical intervention or in-hospital prolonged observation, the extensive use of head CT scan in mTBI has been questioned due to the potential risks related to radiation exposure, as well as unnecessary deployment of ED resources and increased costs, considering that the prevalence of CT-detected intra-cranial injury in mTBI is around 5-10%. For this reason, a number of international clinical guidelines suggest several Clinical Decision Rules (CDR) and algorithms to guide the clinician in the correct management of these patients, in particular in the difficult feat of identifying those patients who don't need to perform neuroradiological evaluation (CT scan or MRI) in the setting of the ED, without the risk to overlook potentially fatal brain injuries. The adjunctive role of these biomarkers has been well characterized in the setting of mTBI. It seems they correlate well with neurological damage as well as with the presence of CT abnormalities, and it seems that they might perform better than clinical evaluation alone. Nonetheless, according to current international guidelines and several systematic reviews and meta-analysis, patients who present with mTBI and risk factors for bleeding and delayed bleeding (such as known coagulopathy, patients on blood thinners or advanced age), need to perform CT scan plus clinical observation or even serial CT scans when the risk of delayed bleeding is considered to be high according to clinical evaluation of the ED physician and according to local standard-of-care and clinical practice. The execution of serial CT scans can be time consuming, expensive for the health-care services, and might pose a significant radiological risk for patients; furthermore, this risk might be unjustified considering that the prevalence of development of late intra-cranial bleeding in patients with risk factors who perform a second head CT scan during observation in the ED is considered to be around 2%. Nonetheless, in this category of patients, clinical observation and the repetition of a second head CT scan is felt to be the safest course of action for patients in order not to overlook potentially fatal injuries. Ideally, a clinical decision algorithm which takes into consideration a serum biomarker with a high negative predictive value for brain injury might aid the clinician to reduce the number of useless CT scans, therefore reducing the observation time in the ED as well as the exposure to ionizing radiations for the patients, while not increasing the number of missed delayed bleedings. At present, the role of GFAP and UCH-L1 in the risk stratification of patients with risk factors for delayed cerebral bleeding after mTBI has not been evaluated yet.
A study in the use of the Narcotrend depth of anaesthesia monitor to record a) seizures, and b) monitor a level of sedation referred to as 'burst suppression', in sedated patients in the adult and paediatric intensive care. Studies have shown that patients in coma on the intensive care unit may have subclinical in addition to clinical seizures. Subclinical seizures are seizures that do not show any outward signs and may go undetected. The current gold standard of recording seizures in the intensive care unit is by non-invasive, continuous monitoring of the electrical activity of the brain by electroencephalography (cEEG) using cerebral function analysing monitor (CFAM). This is recorded with simultaneous video recording and is performed by Clinical Neurophysiology departments. There has been a steady increase in demand for this service over recent years. Additionally, CFAM / cEEG is labour intensive and expensive. If trends continue, the proportion of hospitals offering CFAM / cEEG will continue to rise, creating increased demand for specialist staff, of which there are a finite number. Depth of anaesthesia monitors are used by anaesthetists to assess the level of anaesthesia in sedated patients using specialised, automated EEG analysis and are now recommended by NICE (DG6) to tailor anaesthetic dose to individual patients. This study aims to investigate the utility of the Narcotrend depth of anaesthesia monitor to monitor for seizures and burst suppression on the adult and paediatric intensive care unit. These monitors are cheaper and more widely available with the scope to be used at every bed space requiring neuro observation on the intensive care unit. The study aims to recruit all patients who are referred for CFAM / cEEG monitoring at Nottingham University Hospitals (NUH) Trust over a 12 month period. These patients will undergo simultaneous recording using CFAM / cEEG and depth of anaesthesia monitoring.
The purpose of the present study is to study the effect of baricitinib administration on outcome of participants with moderate and severe traumatic intracerebral hemorrhage/contusions. A multi-center randomized control trial will be conducted. Participants with a radiological diagnosis of traumatic intracerebral hemorrhage/contusions and an initial GCS score of 5-12 will be screened and enrolled in the first 24 hours after traumatic brain injury.
The goal of this clinical trial is to learn about treatment with fresh frozen plasma (FFP) in individuals with moderate to severe traumatic brain injury. The two main question[s]it aims to answer are: - Is the FFP treatment safe? - Does the FFP treatment impact the 24-hour, 3-month and 6-month outcomes, intensive-care free days, mortality, and hospital brain and physical function at discharge. Patients with moderate to severe TBI will randomly receive either: - Standard of care treatment - Standard of care treatment + 2 units of FFP. Researchers will compare participants receiving standard of care treatment to those receiving experimental fresh frozen plasma (FFP) treatment to see if the FFP is safe and beneficial to participant outcomes.
Traumatic brain injury (TBI) accounts for approximately 2.5 million visits to emergency departments in the United States each year. After decades of research, management strategies for severe TBI (sTBI) patients are still evolving. Optimizing intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are paramount in the management of these patients and placement of these monitors is the current standard-of-care. However, monitoring brain oxygenation (PbtO2) with invasive intraparenchymal monitors is currently under investigation in the management of severe TBI and placement of these monitors is gaining widespread use. This has opened the door for the use of tiered therapy to optimize ICP and PbtO2 simultaneously. Current evidence indicates that correction of ICP, CPP and PbtO2 in sTBI requires optimized analgesia and sedation. Ketamine is one of the few drugs available that has both sedative and analgesic properties and does not commonly compromise respiratory drive like opioids and sedative-hypnotics. However, traditionally, ketamine has been viewed as contraindicated in the setting of TBI due to concerns for elevation in ICP. Yet, new data has cast this long-held assumption into significant doubt. Hence the present pilot study will characterize the neurophysiological response to a single dose of ketamine in critically-ill TBI patient with ICP and PbtO2 monitoring.
The design of the present study will be a multicenter prospective observational protocol. Approximately 100 patients will be recruited over the 24-month period with Acute Brain Injury (trauma brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke), who in their acute phase of intensive care unit require placement of a catheter capable of monitoring intracranial pressure (intra parenchymal catheter or external ventricular shunt). In addition to all the intensive care provided by the most recent guidelines, patients will undergo measurement of optic nerve sheath diameter through ultrasonography. At least, three measurements will be performed within the first 3 hours after admission, within the first 24-48 hours, and at each invasive intracranial pressure value greater than 18 cmH2O. Those patients with intracranial pressure values greater than 35 mmHg. At the first intracranial pressure measurement, patients with eyeball disease or trauma will be excluded. Measurements will be performed following the CLOSED bundle. Analysis of the results will include correlation between the invasive pressure values and the mean value of optic nerve sheath diameter measurements in the two projections (sagittal and transverse). In addition, the correlation of the absolute value of invasive pressure detected with the ratio of the optic nerve sheath diameter measurement to the eyeball diameter measured always ultrasound will be sought.
The goal of this interventional study is to Measure the potential benefits of combined administration of cerebrolysin and amantadine sulfate as an add-on therapy to the standard management of patients admitted to the ICU with traumatic brain injury.
The aim of this study is to increase the effectiveness of clinical monitoring of patients with acute cerebral insufficiency by improving the discriminative ability of the FOUR scale. To study the sensitivity and specificity of the FOUR scale as a clinimetric of chronic disorders of consciousness.