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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT05632627 Recruiting - Clinical trials for Brain Injuries, Traumatic

Cannabinoids and Traumatic Brain Injury: A Randomized, Placebo Controlled Trial

Start date: April 11, 2023
Phase: Phase 2
Study type: Interventional

This is a double-blind, placebo-controlled, parallel group study designed to assess the tolerability and efficacy of fsCBD and bsCBD, compared to a placebo control, to improve cognition and traumatic brain injury-related symptoms. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.

NCT ID: NCT05632302 Completed - Clinical trials for Traumatic Brain Injury

A Non-invasive Intracranial Pressure (nICP) Monitoring System

Start date: January 20, 2020
Phase: N/A
Study type: Interventional

Researchers have developed a probe that contains infrared light sources that can illuminate the deep brain tissue of the frontal lobe. Photodetectors in the probe detect the backscattered light, which is modulated by pulsation of the cerebral arteries. Changes in the extramural arterial pressure affect the morphology of the recorded optical pulse, so analysis of the acquired signal using an appropriate algorithm could enable the calculation of the intracranial pressure noninvasively (nICP), which would be displayed to clinicians continuously. This pilot study is the first evaluation of the device in patients in who the gold standard comparator of invasive ICP was available. The acquisition of pulsatile optical signals was performed for up to 48 hours in each of the 40 patients who were undergoing invasive ICP monitoring as part of their normal medical treatment. Features of the optical signals would be analysed offline. A machine vector support algorithm would be implemented, with the aim of estimating ICP noninvasively and compared to the gold standard of synchronously acquired invasive ICP data.

NCT ID: NCT05629169 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Video Review of the Frequency and Assessment of Head Impacts During the FIFA World Cup 2022TM

Start date: November 20, 2022
Phase:
Study type: Observational

This is an exploratory observational study. Broadcasted video footage is used to review all head impacts during all 64 matches in the football tournament. All head impacts are registered, and simple descriptive statistics are used to create overviews of the head impact characteristics, including video signs of potential concussion, observed contact, location of the head impact, presence and timing of medical assessment, whether there was foul play and sanction, and if the player was substituted.

NCT ID: NCT05628207 Recruiting - Clinical trials for Traumatic Brain Injury

Evaluation of the SCALED (SCaling AcceptabLE cDs)

Start date: May 16, 2023
Phase:
Study type: Observational

This project will adapt a currently deployed Clinical Decision Support (CDS) system to deliver a VTE prevention guideline for adult patients with traumatic brain injury (TBI). We believe this is an ideal PCOR use case given PCORI's continued effort to combat VTE in trauma and our experience previously implementing this guideline. The Our overall goal is to successfully scale, evaluate, and maintain an interoperable TBI CDS across 7 total institutions.

NCT ID: NCT05622786 Terminated - Clinical trials for Traumatic Brain Injury

Effect of High-Intensity Gait Training Using a Treadmill on Locomotion Recovery in Traumatic Brain Injury Patients

Start date: October 7, 2022
Phase: N/A
Study type: Interventional

The project will consist of subjects who have suffered Traumatic Brain Injury (TBI) and who are able to ambulate on treadmill with or without a harness system. This will be a 4-week controlled study consisting of two groups of TBI patients, high-intensity intervention group and low-intensity control group. Both groups will receive physical therapy treatment 3 times per week for 1 hour. The intervention group will undergo 30-minute sessions of high-intensity walking on a treadmill with an overhead harness attached for safety. In addition, they will also get up to 30-minutes of low-intensity physical therapy in order to receive 1 hour of treatment time. The control group will undergo only low-intensity physical therapy activities for 1-hour. Low-intensity physical therapy will include strength exercises, stretches, balance, and low-intensity gait training. All participants in both groups will complete these outcome measures on the first day of the study, after 2 weeks of participation, and again at the end of 4 weeks or on their last day before discharge from Carilion's services. Later on, all participants in both groups will be followed up to complete the same set of outcome measures at the end of 1 month since completion of the protocol. This follow up session will take up to 45 minutes to complete.

NCT ID: NCT05622461 Recruiting - Clinical trials for Traumatic Brain Injury

Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery

Start date: February 13, 2023
Phase: N/A
Study type: Interventional

This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) to examine the efficacy of the R2R-TBI intervention in a randomized control trial. To achieve the second goal, we will employ a between-groups randomized treatment design with repeated measures at baseline, one-month post-randomization, and at a six-month follow-up. The two conditions will be: a) usual medical care plus access to internet resources regarding pediatric brain injury (Internet Resources Comparison group, IRC), and b) usual medical care plus the R2R-TBI intervention (Road-to-Recovery group, R2R-TBI).

NCT ID: NCT05616910 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Inhaled Nitric Oxide for Microvascular Dysfunction in Traumatic Brain Injury

Start date: September 1, 2024
Phase: Phase 2
Study type: Interventional

Traumatic brain injury (TBI) causes acute deficits in cerebral perfusion which may lead to secondary injury and worse outcomes. Inhaled nitric oxide (iNO) is a vasodilator that increases cerebral blood flow and is clinically used for hypoxic respiratory failure in neonates and adults. The investigators will perform a randomized controlled trial of iNO treatment in TBI patients acutely after injury. The investigators will then assess perfusion changes with optic neuromonitoring, blood biomarkers, and 6 month clinical outcomes.

NCT ID: NCT05614570 Completed - Clinical trials for Mild Traumatic Brain Injury

SSVEP Evaluation of Brain Function

Start date: January 1, 2019
Phase:
Study type: Observational

The investigational device used in this clinical investigation, the Nurochek Headset, is a portable electroencephalogram (EEG) headset which delivers a visual stimulus and measures a VEP. The visual stimulus is delivered to the subjects' eyes via light-emitting diodes, and the EEG measures the user's visual-evoked potential. This headset communicates with an application on a smartphone which processes the signals and transmits them to a secure cloud server for analysis and storage of the data. The primary objective of this clinical investigation was to evaluate the performance of the investigation device (NCII) against clinical diagnosis and SCAT 5, in the accurate detection of mild traumatic brain injury (mTBI). The primary endpoint outlined for this study was set at the collection of 100 valid investigational device readings from individuals with concussion The aim of this study was to collect data from 100 readings from individuals with concussion. It was estimate that approximately 10-20% of baselined players would suffer a concussion during the season. There it was estimated there would be a need to baseline 500-1000 individuals in order to achieve the number of concussions required. The initial assumption was that sites would provide players pre-season and make players available for testing post-concussion. In practice, some sites provided player data only post-concussion event (such as medical clinics). Participants were required from sporting clubs, medical clinicals and schools.

NCT ID: NCT05609734 Completed - Clinical trials for Traumatic Brain Injury

No Cases of Delayed Intracranial Hemorrhage (d-ICH) Among Patients With Mild Traumatic Brain Injury (mTBI) on Oral Anticoagulation Therapy

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

Abstract Purpose Patients with anticoagulation therapy has a higher risk of developing traumatic Intracranial Hemorrhage (tICH). Delayed Intracranial Hemorrhage (d-ICH) is a rarer clinical manifestation; however, the incidence varies from 0-9,6 % in other studies. Some studies have also questioned the clinical relevance of d-ICH, since the mortality and the need of neurosurgical intervention is reported to be very low. The aim of this study is to determine the incidence of d-ICH at Sundsvall Regional Hospital. Methods A retrospective observational study of patients with mTBI and oral anticoagulation therapy. Data from medical records and radiology registry in Sundsvall hospital for 29 months during 2018-2020 in Sundsvall identified 249 patients with an initial negative CT scan who performed a follow-up CT scan. Outcome measure was incidence of d-ICH.

NCT ID: NCT05609721 Completed - Brain Injuries Clinical Trials

Mild Traumatic Brain Injury and the Risk for Traumatic Intracranial Hemorrhage

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

Management of traumatic brain injuries causes significant efforts on emergency departments (ED) and overall health care. Patients on antithrombotic treatment with even minor trauma to the head, although without significant clinical findings, represent special challenges because the risk of traumatic intracranial hemorrhage (tICH) with these agents. The aim of this study was to compare the prevalence of tICH in patients on various pre-injury antithrombotic treatment exposed to minor Traumatic Brain injuries (mTBI) in Sundsvall with untreated patients. Secondary aim was to explore different risk factors for tICH. Data from medical records and radiology registry with mTBI in Sundsvall hospital between 2018-2020 in Sundsvall identified 2044 patients. Demographic data, pre-injury medications with antithrombotic treatment, state of consciousness at admission and the results of CT-scans of brain was investigated.