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Craniocerebral Trauma clinical trials

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NCT ID: NCT05788146 Not yet recruiting - Stroke Clinical Trials

A Blended Psychological Intervention for Depression After Acquired Brain Injury

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

1.3 million people in the UK live with an Acquired Brain Injury (ABI) as a result of experiencing a stroke or traumatic brain injury (TBI). Up to 50% of individuals with ABI will experience depression. NICE guidelines recommend Cognitive behaviour therapy (CBT) for depression after ABI. There is growing interest into increasing access to CBT through mHealth technology, including mobile applications. Objective: Phase 1 of the study aims to investigate whether a blended psychological intervention, using a novel smartphone-based application alongside individual therapy sessions is acceptable and feasible for targeting depression after ABI. Phase 2 of the study aims to use qualitative interviews to better understand the participants' experiences of using the mobile app as part of the intervention. Methodology: The researchers aim to recruit 20 individuals with ABI, who are experiencing mild-moderate symptoms of depression. Participants will complete outcome measures and cognitive tasks at the beginning of the study. Participants will then receive a six-week blended psychological intervention; engaging the CBT-based mobile app alongside weekly, 30-minute video or telephone sessions for therapeutic and technology support. Participants will then be asked to complete the same outcome measures as completed at the beginning of the study. Participants will then be invited to take part in a 30-minute interview about their experience of using the mobile app as part of the intervention. Data Analysis: Change scores will be calculated from the data collected as part of phase 1 of the study, to investigate initial efficacy. Recruitment and dropout rates will help determine the feasibility of the blended intervention. In the 2nd phase, qualitative data will be analysed following Ritchie and Lewis (2003)'s Framework Analysis. Findings: Results from this study will help increase understanding into the acceptability and feasibility of using mHealth technology for treating depression following ABI. If effective, it could help to increase access to psychological interventions for individuals living with ABI. We hope to publish findings in a peer reviewed journal.

NCT ID: NCT05663034 Not yet recruiting - Depression Clinical Trials

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

NCT ID: NCT05626465 Not yet recruiting - Abuse, Child Clinical Trials

Biomarker-s of Abusive Head Trauma by Proteomics

Start date: February 2023
Phase:
Study type: Observational

The aim of our study is to highlight biomarker-s of Abusive Head Trauma by proteomics analyses on the serum of child victims of abuse.

NCT ID: NCT05210855 Not yet recruiting - Closed Head Injury Clinical Trials

Comparison of Image Quality Between Ultra-low Dose (ULD) and Standard Dose CT Scans in Detecting Traumatic Brain Injury in the Emergency Room

ULD-CRANE 2
Start date: March 2022
Phase: N/A
Study type: Interventional

Head trauma is a frequent reason for consultation in the emergency room. The CT scan is the reference examination allowing rapid management of the patient. However, CT examinations are among the diagnostic examinations with the highest exposure to ionizing radiation. The study investigators have previously implemented "ultra-low dose" (ULD) acquisitions for several pathologies with an effective dose level similar to that of a standard radiographic examination. These ULD acquisitions are now routinely used in our clinical practice for explorations of the thorax, spine, pelvis and proximal femurs, extremities. This study expands these ULD acquisitions to skull CT for detecting traumatic intracranial lesions. The study investigators hypothesize that it would be possible to search for intracranial lesions in patients with head trauma using ULD protocols, thereby reducing the doses delivered to the patient while maintaining sufficient image quality for the diagnosis.

NCT ID: NCT05195606 Not yet recruiting - Nursing Caries Clinical Trials

The Effect of Auditory and Tactile Stimuli in Traumatic Coma

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

This study focused on examining the effects of auditory and tactile stimuli to reduce sensory deprivation on consciousness, oxygen saturation and mean arterial pressure in traumatic coma patients.

NCT ID: NCT05091125 Not yet recruiting - Clinical trials for Mild Head Trauma With Risk of Complications

Diagnostic Performance of the S100B Protein in the Prognosis of Patients With Mild Head Trauma With Risk of Complications in Patients Over 65 Years Old.

Start date: November 2, 2021
Phase:
Study type: Observational

For patients with mild head trauma, a large number of CT scans are performed. The S100B protein allows, when the dosage is below the threshold, to rule out the diagnosis of brain damage with a negative predictive value of 98%. In patients over 65 years old it was found that the dosage of S100B came back positive more often compared to a younger population. This study proposes to determine the positivity threshold value for S100B dosage in patients over 65 years old. In patients over 65 years suffering from mild head trauma, a head CT will systematically be performed (in accordance with the recommendations) and the S100B will be measured (taken from an additional tube on the blood test carried out in these patients). The results of the TDM will then be compared with the results of the S100B to determine the values of sensitivity, specificity, negative and positive predictive value of different thresholds.

NCT ID: NCT04946747 Not yet recruiting - Concussion Clinical Trials

Detection and Prevention of Concussive Injuries With Smart Technology.

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

Concussions are consequences of inopportune interactions between an impact force and the head that causes the head (and brain) to move too rapidly. This project involves two parts. 1. The outcome of head-impact depends upon the force and the biomechanical properties of the head-and-neck. Modern microelectrical mechanical systems (MEMS) head-impact sensors only measure the physical parameters of external forces. The researchers have developed a next-generation smart MEMS sensor fortified with artificial intelligence (AI) that can help define a personalized concussive threshold. The researchers sensor machine-learns the biomechanical properties of the participant's head-and-neck and accurately determines the likelihood for concussive injuries. The researchers first goal is to field-test the sensor in soccer players. 2. Researchers hypothesize that an increase in neck stiffness should reduce concussive risks. The researchers have developed a training protocol that involves a conditioned response (CR) to increase neck stiffness during a head-impact event and thereby decrease concussion risk. The Researchers have also developed technology to monitor neck stiffness. The smart sensor is fully integrated into the training protocol and monitors the neck stiffness to validate the effectiveness of the training. The second goal is to optimize and finalize our training protocol and conduct a field-test in soccer players.

NCT ID: NCT04574349 Not yet recruiting - Head Injury Trauma Clinical Trials

Decompressive Craniectomy Following Trauma

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

A prospective clinical trial on trauma patients with increased intracranial pressure(ICP) applied for decompressive craniectomy to lower ICP

NCT ID: NCT03970421 Not yet recruiting - Length of Stay Clinical Trials

Severity Factors and Needed Observation Time at ED of Patients Wih Head Injury

HESCTCE
Start date: June 2019
Phase:
Study type: Observational

We know precisely which patients and when they should have an imaging test to evaluate a Head Injury (HI). But in those patients on anticoagulant and / or antiaggregant treatment we do not know the exact incidence of early and late hemorrhagic lesions, and there is no specific recommendation on how long they should remain under observation in the emergency department if no initial lesions are evident. Our goal is to try to answer these two questions.

NCT ID: NCT03721003 Not yet recruiting - Head Injury Trauma Clinical Trials

Intracranial Pressure Monitoring in Sever Traumatic Brain Injury Single Center Experience

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

Intracranial pressure (ICP) is defined as the pressure inside the skull, and therefore, the pressure inside the brain tissue and the cerebrospinal fluid (CSF). The relationship between CSF and intracranial blood volumes is described by the Monroe Kellie doctrine; because the brain is incompressible, when the skull is intact, the sum of the volumes of brain, CSF, and intracranial blood is constant.