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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT06423469 Completed - Clinical trials for Traumatic Brain Injury

Noninvasive Intracranial Pressure Waveforms Assessment in Traumatic Brain Injury

Start date: February 1, 2020
Phase:
Study type: Observational [Patient Registry]

In clinical practice, hospital admission of patients with altered level of consciousness ranging from drowsiness to decreasing response states or coma is extremely common. This clinical condition demands effective investigation and early treatment. Imaging and laboratory tests have played increasingly relevant roles in supporting clinical research. One of the main causes of coma is intracranial hypertension (IH), with traumatic brain injuries (TBI) and cerebral hemorrhages being the major contributors to its development. IH increases the risk of secondary damage in these populations, and consequently, morbidity and mortality. Clinical studies show that adequate intracranial pressure (ICP) control in TBI patients reduces mortality and increases functionality. Unfortunately, the most accurate way to measure and evaluate the ICP is through a catheter located inside the skull, and its perforation is required for this purpose. Several studies have attempted to identify noninvasive solutions for ICP monitoring; however, to date, none of the techniques gathered sufficient evidence to replace invasive monitors. Recently, an extensometer device has been developed, which only maintains contact with the skull's skin and therefore eliminates the need for its perforation, being able to obtain recordings of cranial dilatation at each heartbeat and consequently reflecting brain compliance. In vivo studies have identified excellent qualitative correlation with catheter ICP recordings. However, this device was evaluated only in a limited number of clinical cohorts and the correlations between the information provided by this device with patients outcomes is still poor. Therefore, this project aims primarily to evaluate the use of this noninvasive brain compliance monitoring system in a cohort of TBI patients.

NCT ID: NCT06306950 Completed - Clinical trials for Severe Traumatic Brain Injury

Prioritization of Cerebral Deoxygenation in Severe Traumatic Brain Injury and Mortality Benefit.

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

Severe traumatic brain injury with a decrease in cerebral oximetry is associated with multiple impaired systemic microcirculations, more morbidities, and a higher mortality rate. When using the brain as an index organ, interventions to improve brain oxygen delivery may have systemic benefits for these patients.

NCT ID: NCT06304012 Completed - Clinical trials for Traumatic Brain Injury

Effect of Oral Enteral Nutrition on Severe Traumatic Brain Injury

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

NCT ID: NCT06156735 Completed - Stroke Clinical Trials

Music Therapy on Cognition in Neurorehabilitation

Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Music therapy has received more attention with its surging application in neuro-rehabilitation overseas. Given the dearth of music therapy and cognitive rehabilitation research conducted in Malaysia, this pilot study intended to investigate the effect of active and passive music therapy interventions versus the standard care condition in cognition among adults with neuro-rehabilitation needs.

NCT ID: NCT06118541 Completed - Clinical trials for Vestibular Rehabilitation

Vestibular Rehabilitation Exercise in Mild Traumatic Brain Injury

Start date: May 20, 2022
Phase: N/A
Study type: Interventional

Traumatic brain injury (TBI) is a leading cause of long-term disability and mortality. The costs associated with hospitalization, rehabilitation, and productivity losses after injury impose a significant socioeconomic and healthcare burden. TBI patients often struggle with symptoms such as dizziness and post-concussion syndrome, preventing them from returning to their previous level of functioning. This leads to negative consequences, including unemployment, psychosocial adjustment difficulties, and decreased quality of life, particularly affecting young working-age individuals. The purpose of this study was to investigate whether vestibular rehabilitation exercises for mild traumatic brain injury (mTBI) patients could improve symptoms of dizziness, post-concussion syndrome, physical balance, anxiety, and quality of life. The study aimed to provide individualized care plans for mTBI patients, reducing symptom burden, lowering healthcare costs, and enhancing their quality of life.

NCT ID: NCT06039098 Completed - Clinical trials for Traumatic Brain Injury

Investigating CBF and ICP Using DCS

ICP-CBF
Start date: January 5, 2023
Phase:
Study type: Observational

We aim to acquire data using DCS on patients who are undergoing invasive ICP and ABP monitoring on ITU as part of their normal treatment. Data will then be correlated to derive various parameters including CBF and BFI. All interventions are entirely non-invasive.

NCT ID: NCT06007807 Completed - Clinical trials for Traumatic Brain Injury

Severe Trauma Registry in Tarragona

IcuTrauma
Start date: January 1, 2015
Phase:
Study type: Observational [Patient Registry]

Severe trauma is one of the leading causes of morbidity, mortality, and disability worldwide. Currently, it is the primary cause of death among individuals under 45 years of age. This disease, considered a "silent pandemic," exhibits heterogeneous physiopathology and unequal geographic distribution in terms of the type of injuries. The prognosis of subjects who have suffered severe trauma is uncertain, especially in patients with traumatic brain injury. The epidemiology of severe trauma has undergone changes in recent years due to the global aging of society, resulting in different populations with older ages and more associated comorbidities. These factors are frequently linked to the use of chronic treatments such as antiplatelet agents or anticoagulants, which could worsen traumatic hemorrhage-the leading preventable cause of death following severe trauma. Despite efforts for primary prevention, such as road safety campaigns and occupational risk prevention, the annual incidence of severe trauma cases worldwide remains high. Enhancing the management of trauma patients would significantly influence the final clinical outcomes. Given the aforementioned, it is of vital importance to understand the local epidemiology of severe trauma for the development of clinical research. This constitutes an effective tool to investigate changes in clinical practices, improve prevention strategies, and determine the global burden of the disease. The hypothesis of the IcuTrauma Project is to create a territorial Registry of adults with severe trauma admitted to the ICU to understand the local epidemiology in Tarragona (Spain). This initiative would facilitate new lines of clinical research aimed at improving outcomes and the quality of care for trauma patients.

NCT ID: NCT05992194 Completed - Clinical trials for Traumatic Brain Injury

Repeatability Assessment of Neurovisual Tasks for the Construction of a New Concussion Monitoring Tool (SPORTICARE)

SPORTiCARE
Start date: August 23, 2023
Phase:
Study type: Observational

Traumatic brain injury (TBI) is a condition that occurs when a mechanical blow to the head causes damage to the brain. The diagnosis of this pathology requires the evaluation of several dimensions, including clinical symptoms, physical signs, cognitive disorders, behavioral and sleep disturbances and state of consciousness. This multidimensional approach provides a comprehensive and accurate assessment of head injury and its severity. The Berlin Consensus of the International Conference on Concussion in Contact Risk Sports held in Berlin in 2016 (McCrory et al., 2017) emphasized that the management of a CTE must be multimodal and multidisciplinary. This expert consensus converged on a tool that is now the most widely used in protocols studying concussion in sports at risk of BTI. This tool, the SCAT 5 (Sports Concussion Assessment Tool), combines symptom assessment, cognitive examination, neurological examination (oculomotricity, balance) and immediate and delayed memory. However, it requires the intervention of a medical expert to assess the clinical signs of the concussed athlete. Hänninen et al (2021) showed that test-retest reproducibility was very good for the clinical symptomatology subscore, but poor or average for the subscores summarizing cognitive tests and balance assessment. Clinicians now need to be able to better assess the severity of damage following head injury, and to monitor the patient's progress. This will improve the management of concussed athletes right up to their eventual return to sporting activity. The ultimate aim of our project is to develop and optimize an easily exportable multimodal concussion assessment tool, based on the use of a virtual reality headset, which will enable us to objectively characterize the state and evolution of a subject after a TCE. This will enable the assessment of neuro-visual functions and compensations in the concussed patient, revealing a higher attentional cost characterized by instability of orthostatic control, higher blink frequency and larger pupil size. The multimodal tool will be built from the results of various tests: - Standardized oculomotor tasks(pro-saccades, anti-saccades, smooth pursuit, memory guided saccades, self paced saccades) - Orthostatic balance control to assess postural compensations and estimate attentional cost during oculomotor tasks. - Pupil dynamics using the Pupil Cycle Time (PCT) test. The aim of this exploratory study is to determine the repeatability of measurements provided by the SPORTiCARE virtual reality headset during different tasks.

NCT ID: NCT05958277 Completed - Clinical trials for Traumatic Brain Injury

Vitamin B12 vs B3 for Nerve Regeneration and Functional Recovery After Pediatric Traumatic Brain Injury

Start date: June 1, 2021
Phase: Phase 3
Study type: Interventional

A traumatic brain injury (TBI) is among the most frequent reasons for neurological impairment in young people. The investigators investigated whether vitamin B12 vs B3 therapy could reduce the severity of traumatic brain injury (TBI) due to their positive effects on axon regrowth following nerve damage. The method utilized was a series of non-random samples. With a 95% confidence interval and a 5% margin of error, a total sample of 300 patients was estimated using Epi Info. Participants in our study comprised both boys and girls with severe TBI ages 6 to 15 years old. Two groups of 300 children were recruited. B3 (16 mg/day) was administered to group 1 and B12 (125-250 mcg/day) was provided to group 2. It is evaluated through follow-ups on a range of tests to evaluate cognitive capacity, sensorimotor activity and staircase test (working and reference memory). Pre-and post-treatment GCS measurements were conducted. Three weeks and a year following the treatment of TBI, children underwent neurobehavioral testing. The measurement of gait analysis was done. The standard error and mean of statistically examined data were shown by paired t-test.

NCT ID: NCT05951335 Completed - Stress Clinical Trials

m-Health Supportive Care Transition Program in Improving Post-Discharged Outcomes

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

This intervention study aims to investigate the effects of the m-Health supportive care transition program on response patterns (transition stress and the burden of caregiving) among traumatic brain injury (TBI) caregivers and patients' readmission rate one month after hospital discharge. Specific objectives: 1. Compare the response patterns (transition stress and the burden of caregiving) of TBI caregivers before and after receiving the program within the group. 2. Compare TBI caregivers' response patterns (transition stress and the burden of caregiving) between the control and intervention groups. 3. Compare patients' readmission rates at one month after hospital discharge between the control and intervention groups TBI caregivers are divided into two groups: the intervention group (who receive the transitional care program) and the control group (who receive the standard care program) according to standard operating procedures applicable in the hospital. If there is a comparison group: Researchers will compare [insert groups] to see if [insert effects]