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Traumatic Brain Injury clinical trials

View clinical trials related to Traumatic Brain Injury.

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NCT ID: NCT03597763 Completed - Clinical trials for Traumatic Brain Injury

Fatigue Following Moderate and Severe TBI

Start date: March 1, 2018
Phase:
Study type: Observational

The subjective feeling of being periodically fatigued, tired, even exhausted is common in the general population, as well as in a large number of medical conditions, including neurological illness, such as traumatic brain injury (TBI), cerebrovascular accidents (CVA), multiple sclerosis (MS), and poliomyelitis. Fatigue typically results in compensatory behaviors such as spending extended time in bed, daytime napping, and restricted participation in activities of daily living, which in turn can have a profound negative impact on mental and physical health. Although fatigue is common and debilitating, there is a scarcity of knowledge concerning underlying biological, psychological and psychosocial mechanisms in the development and maintenance of persisting fatigue. There is also a general lack of theoretical accounts of potentially shared and etiology-specific mechanisms across conditions. The existence of clinical subgroups and diverse clinical trajectories is not well documented, resulting in a lack of evidence-based treatment opportunities. Diagnosis and management of fatigue is further challenged by difficulties in conceptualizing and defining the phenomenon itself, since fatigue is subjectively experienced and multifaceted. Thus, as fatigue often poses a chronic problem, health professionals in community based rehabilitation settings are faced with helping patients cope with this symptom without a clear understanding of causes or treatment options. The current project aims to map the occurrence of fatigue following moderate to severe TBI and achieve a better theoretical and clinical understanding of the mechanisms which may cause, exacerbate or protect against persisting fatigue following TBI. The study approach acknowledges that fatigue after neurological illness is the result of complex interplays between general individual predispositions and etiology-specific factors. A better understanding of these mechanisms is a prerequisite for personalized treatment and development of empirically based randomized controlled intervention studies. This approach has relevance to other clinical conditions as well. The long-term aim is to ensure accurate diagnosis, improve treatment and rehabilitation, and to contribute to knowledge based clinical decision-making both within specialized and community based rehabilitation settings.

NCT ID: NCT03594734 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Group Lifestyle Balanceā„¢ for Individuals With Traumatic Brain Injury (GLB-TBI)

Start date: January 8, 2019
Phase: N/A
Study type: Interventional

The purpose of this RCT is to examine the efficacy of a Group Lifestyle Balanceā„¢ (GLB) program adapted for people with traumatic brain injury (TBI) on primary (weight) and secondary outcomes at 3, 6, 12, and 18 months from enrollment into the program.

NCT ID: NCT03582228 Completed - Clinical trials for Traumatic Brain Injury

Bridging Recovery Allies in Virtual Environments

BRAVE
Start date: August 6, 2018
Phase: N/A
Study type: Interventional

The Bridging Recovery Allies in Virtual Environments (BRAVE) study aims to evaluate the acceptability and feasibility of implementing a virtual environment (VE) social support group for social communication training among adults with traumatic brain injury (TBI).

NCT ID: NCT03575169 Completed - Clinical trials for Traumatic Brain Injury

The Use of Bispectral Index Monitoring to Assess Depth of Sedation in Patients With Traumatic Brain Injury

BIS-TBI
Start date: July 1, 2019
Phase:
Study type: Observational

An observational study to assess the BIS reported level of sedation of patients with traumatic brain injury in the ICU.

NCT ID: NCT03565549 Completed - Clinical trials for Traumatic Brain Injury

VAGABOND: a Mnemonic to Aid in the Memory Retention of the Canadian CT Head Rule

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

The aim of this study is to assess the effectiveness and usefulness of a simple one word mnemonic in the memory retention of the different components of the Canadian CT Head Rule (CCHR) in senior medical students and interns. The CCHR, a clinical decision rule used by emergency physicians to determine the need of head CT in the context of minor traumatic brain injury (mTBI). A rapid recall of the rule in the clinical setting would be expected to improve its utilization and overcome one of the barriers in its implementation. This would ultimately result in better utilization of resources and reduction in unnecessary exposure to radiation.

NCT ID: NCT03562104 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Swallowing Disorders in Minimally Consciousness Patients (MCS)

TC-DEG
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

This study aimed to characterize swallowing disorders in minimally consciousness patients after brain traumatic injury.

NCT ID: NCT03559114 Recruiting - Clinical trials for Traumatic Brain Injury

PROphylaxis for Venous ThromboEmbolism in Severe Traumatic Brain Injury (PROTEST)

PROTEST
Start date: July 19, 2018
Phase: Phase 3
Study type: Interventional

This is a pilot study, phase III, multi-centre, double blind, randomized controlled trial of patients with traumatic brain injury (TBI).

NCT ID: NCT03554265 Completed - COVID-19 Clinical Trials

Brain and Gut Plasticity in Mild TBI or Post-acute COVID Syndrome Following Growth Hormone Therapy

Start date: August 6, 2018
Phase: Phase 3
Study type: Interventional

Patients with a history of mild traumatic brain injury (mTBI) or post acute sequelae of SARS-CoV-2 (PASC) and abnormal growth hormone secretion, as measured by glucagon stimulation test, will be treated with replacement growth hormone therapy for a period of 6 months (mTBI) or 9 months (PASC). Testing of cognition, exercise, fatigue, brain activation and morphology, body composition and measurements of quality of life will be performed before and after the treatment period. Fecal sampling for characterization of the GI microbiome will occur monthly over the treatment period. Control subjects will be enrolled and will provide fecal samples monthly for 6 months. GI microbiomes will be compared between mTBI patients, PASC patients and controls at baseline as well as over the treatment period.

NCT ID: NCT03549572 Recruiting - Clinical trials for Traumatic Brain Injury

Validity and Feasibility of the CRSR-FAST

CRSR-FAST
Start date: August 28, 2018
Phase:
Study type: Observational

The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings. One limitation of the CRS-R is the lengthy administration time required to obtain a total score. Administration time can vary from approximately 15-30 minutes, depending on the patient's level of responsiveness. For this reason, the CRS-R is rarely administered in the acute hospital setting. Less time-consuming scales and metrics are used to assess conscious awareness in the acute hospital/ICU setting, but they lack specificity and sensitivity and have not been validated, increasing the potential for misdiagnosis. In conjunction with the developers of the Neuroscore (an unpublished, abbreviated version of the CRS-R), we have developed the CRSR-FAST and aim to test its validity, inter- and intra- rater reliability. We anticipate that, compared with the CRS-R, the CRSR-FAST will be less time-consuming to administer and score, but will maintain a high level of sensitivity to detecting signs of consciousness in severely brain injured patients.

NCT ID: NCT03545594 Completed - Clinical trials for Traumatic Brain Injury

Traumatic Brain Injury; Needs and Treatment Options in the Chronic Phase

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

Traumatic brain injury (TBI) is a condition affecting the persons' central nervous system with a need for extensive and highly specialized initial health care provision followed by comprehensive rehabilitation efforts. Frequent and life-long medical, cognitive, emotional and behavioral changes are expected. The community-based services are largely responsible for dealing with the chronic challenges affecting people with TBI. 120 patients >16 years at the time of injury and between 18 and 72 years at inclusion, with clinical TBI diagnosis on acute admission and verified injury-related intracranial abnormalities reporting cognitive, emotional and physical problems more than 2 years after the injury will be included and randomized to a patient-centered in-home program intervention and treatment as usual. The intervention consists of an individualized and goal-oriented intervention will be provided in the persons' home environment, in close collaboration with family members and local health care providers when available. Assessments will be conducted at baseline, at the end of the intervention 4 months after inclusion and one year after inclusion. Primary outcome is participation (Part-O) and TBI specific health related quality of life (Qolibri). Secondary outcomes include goal attainment within individualized targeted outcome areas, depression and anxiety, symptom burden, unmet health care needs and acceptability of intervention as assessed by patient, family member and health professional. The project will contribute to increased understanding of knowledge transfer processes, and dissemination of evidence based practice for TBI. Thus, the project has the potential to improve the current health care for patients with TBI and its delivery.