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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT05048966 Recruiting - Dementia Clinical Trials

Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons

Start date: December 8, 2022
Phase: N/A
Study type: Interventional

Approximately 5.3 million people live with a long-term disability resulting from a traumatic brain injury (TBI) and between 5-8% of those older than 60 suffer from Alzheimer's disease or other forms of dementia (ADRD). Consequences of these conditions can result in dramatic and persistent changes in functioning, impacting not only the patients, but also loved ones who become informal support persons. Many existing services help the family in the moment, but do not address long-term wellness. Thus, the purpose of this research study is to compare the effect of two different types of group wellness treatments for individuals with chronic mild TBI, moderate to severe TBI, and ADRD and their support persons.

NCT ID: NCT05038930 Recruiting - Clinical trials for Subarachnoid Hemorrhage

Mobilising Patients With Severe Brain Injury in Intensive Care

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

Introduction Patients with severe brain injury are often restricted to bed rest during the early period of brain injury which may lead to unwanted secondary complications. There is lack of evidence of when to initiate the first mobilisation. The Sara Combilizer® is an easy and efficient tool for mobilising patients with severe injuries, including brain injury. Through a randomised cross-over trial the investigators will investigate the impact of early mobilisation on patients with severe acquired brain injury caused by traumatic brain injury, subarachnoid brain injury or intracranial haematoma. The investigators hypothesise that mobilisation using the Sara Combilizer® does not affect partial oxygenation of brain tissue.

NCT ID: NCT05033444 Recruiting - Clinical trials for Traumatic Brain Injury (TBI)

A First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers

Start date: September 17, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of different dose levels of PRV-002 in Health Volunteers

NCT ID: NCT05022940 Recruiting - Clinical trials for Traumatic Brain Injury

Functional Evolution of Traumatic Brain Injured Adults During Rehabilitation and Social Participation

Start date: June 1, 2017
Phase:
Study type: Observational

The research project aims to better understand the multiple factors related to the clinical evolution and the social participation of traumatic brain injured (TBI). The project will provide better understanding of the patients' evolution during rehabilitation after TBI in terms of adaptation and social participation, assess the effect of rehabilitation and study social participation outcomes and quality of life of TBI patients one-year post-rehabilitation. Project benefits include improvement of clinical practices and support in decision-making. The objectives of this research project are: Part 1: To provide a picture of the evolution, in terms of social adaptation and participation of patients during rehabilitation after a TBI. Part 2: To study social participation outcomes and quality of life of TBI individuals one year after the end of their rehabilitation.

NCT ID: NCT05009511 Recruiting - Clinical trials for Major Depressive Disorder

MRI Markers of Feedback Timing During Learning in Individuals With TBI With and Without Clinical Depression

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

The goal of this proposal is to examine the influence of feedback timing on learning and brain function in individuals with moderate-to-severe traumatic brain injury (TBI), with and without depression.

NCT ID: NCT05008419 Recruiting - Clinical trials for Traumatic Brain Injury

Narrative Discourse Treatment Development

Start date: November 27, 2023
Phase: N/A
Study type: Interventional

Discourse impairments are breakdowns in meaningful communication beyond the level of single sentences and have a functional impact on the lives of Veterans with TBI, disrupting return to work, communication re integration, socialization, and quality of life. The few prior attempts to treat discourse impairments have been small case studies and resulted in no change or limited gains. The proposed study evaluates the feasibility of a novel narrative discourse treatment that builds upon these prior attempts by addressing breakdowns in both story content and story organization using a theoretically-driven approach. If feasible, as demonstrated by tolerability and acceptability to participants, and later shown to be effective, the proposed discourse treatment has the potential to improve daily communication, which provides a gateway for Veterans with TBI to increase meaningful participation and improve functioning in major life domains.

NCT ID: NCT04995068 Recruiting - Clinical trials for Traumatic Brain Injury

Score Predicting Lesion Development on CT Following Mild TBI

SELECT-TBI
Start date: March 1, 2021
Phase:
Study type: Observational

Mild traumatic brain injury (mTBI) is one of the most common reasons behind emergency department (ED) visits. A small portion of mTBI patients will develop an intracranial lesion that might require neurosurgical intervention. Several guidelines have been developed to help direct these patients for head Computerized Tomography (CT) scanning, but they lack specificity, mainly focus on ruling out lesions, and do not estimate the risk of lesion development. The aim of this retrospective observational study is to create a risk stratification score that predicts the likelihood of intracranial lesion development, lesion progression, and need for neurosurgical management in patients with mTBI presenting to the ED. Eligible patients are adults (≥ 15 years) with mTBI (defined as admission Glasgow Coma Scale (GCS) 13-15) who presented to the ED within 24 hours of injury to any ED in Stockholm, Sweden between 2010-2020. Reasons for ED visit and Internal Classification of Disease (ICD) codes will be used to screen for patients. Machine-learning models will be applied. The primary outcome will be a traumatic lesion on head CT, defined as a cerebral contusion, subdural haematoma, epidural haematoma, subarachnoid haemorrhage, intraventricular haemorrhage, diffuse axonal injury, skull fracture, traumatic infarction or sinus thrombosis. The secondary outcomes will be any clinically significant lesion, defined as an intracranial finding that led to neurosurgical intervention, discontinuation or reversal of anticoagulant or antiplatelet medication, hospital admission > 48 hours due to the TBI, or death.

NCT ID: NCT04982731 Recruiting - Clinical trials for MTBI - Mild Traumatic Brain Injury

Positive Assurance and mTBI

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

This study will develop and validate a new ED discharge educational video that provides positive assurance about mild traumatic brain injury (mTBI) recovery for patients with mTBI.

NCT ID: NCT04982562 Recruiting - Clinical trials for Post-Concussion Syndrome

Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mild Traumatic Brain Injury

SPIN
Start date: June 26, 2021
Phase: N/A
Study type: Interventional

We aimed to conduct a prospective longitudinal interventionnal monocentric study to assess the ability of seven tesla MRI to detect diffuses axonal lesions in patients presenting a post concussional syndrom (PCS) at seven days about a mild traumatic brain injury (MTBI). Our first objective was to evaluate the diagnostic performance of seven tesla MRI runned at seven days after MTBI among patients presenting a PCS.

NCT ID: NCT04977843 Recruiting - Clinical trials for Traumatic Brain Injury

Effect of E-BAL on Severity of VAP Assessed Through CPIS on the Patients of Traumatic Brain Injury in Neurocritical Care, Also Effect on Days of Ventilation and ICU Stay.

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

Severe traumatic brain injury (STBI) is a leading cause of disability, mortality, and economic burden worldwide. The impact of severe traumatic brain injury (STBI) on the economy of developing countries like Pakistan is distressing. Pakistan has a large proportion of the young adult population in the World. Motorbike is the most common locomotive vehicle. These young ones are in the economically productive part of their lives. Their loss is an economical set back not only for their families but also for the Nation. Patients with STBI need standardized management in Neuro-critical care unit (NCCU). Although the setup and maintenance cost of an effective NCCU is one of the major burden on the budget of any public sector hospital, but the young survivor in turn can be productive for the Nation. During mechanical ventilation, severe traumatic brain injury patients frequently develop ventilator-associated pneumonia (VAP). Ventilator-associated pneumonia can be evaluated using Clinical pulmonary infection score (CPIS). CPIS is considered as an important clinical indicator of pneumonia in NCCU. Bronchoalveolar Lavage (BAL) is a minimally invasive procedure done with instillation of normal saline into subsegments of the lung followed by suction and collection of the instilled fluid for analysis with flexible bronchoscope. Patients with moderate and severe traumatic brain injury usually present with altered conscious level, and most of them already have aspiration of vomitus, debris and secretions which increase the risk of VAP in them. Bronchoalveolar lavage can be helpful in preventing this dreadful VAP by clearing the airways. The aim of this study is to find out the effect of early Bronchoalveolar Lavage on severity of development of VAP assessed through clinical pulmonary infection score (CPIS) in TBI patients.