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Brain Injuries clinical trials

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NCT ID: NCT05380050 Recruiting - PTSD Clinical Trials

Comparing Telehealth to In-person a Combined Metacognitive Training in Veterans With mTBI/PTSD

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

Veterans with mild traumatic brain injury (mTBI) and post-traumatic stress disorder (PTSD) commonly experience cognitive impairments including attention and executive function deficits that interfere with their ability to engage in productive personal and social activities. Of the limited interventions available to address cognition, none rigorously train attention beyond strategy management. This study will evaluate an innovatively combined strategy training known as Goal Management Training plus computerized attention training in Veterans with mTBI/PTSD. Preliminary testing suggests an effectiveness in improving problem solving, attention and functional tasks in a small number of Veterans. Considering these promising results, cost effectiveness, and the demand for access to care from Veterans living in rural areas, a Randomized Controlled Trial will determine and compare the effects of this treatment, administered either in-person or via telehealth, on executive function, attention, other aspects of cognition and real life functional tasks.

NCT ID: NCT05365776 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Graded Exposure Therapy for Fear Avoidance Behaviour After Concussion

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

Concussions are very common. Although many people recover well from concussion, some will have persistent symptoms and difficulties with daily activities. How people cope with their symptoms following concussion powerfully influences their recovery. Fear avoidance behaviour is a particularly unhelpful approach to coping, in which people perceive their pre-injury activities as unnecessarily dangerous and take great care to avoid overexertion and overstimulation. The investigators developed and pilot tested a behavioural therapy, called graded exposure therapy, to reduce fear avoidance behaviour. Our preliminary work suggested that graded exposure therapy was acceptable to patients with concussion and possibly beneficial for their recovery. The GET FAB after concussion study will assess the effectiveness of graded exposure therapy.

NCT ID: NCT05364749 Recruiting - Clinical trials for Traumatic Brain Injury

Selective CT for Anticoagulated Head Injured Patients

Can-SCAHn
Start date: March 17, 2022
Phase:
Study type: Observational

The goal is to derive and a clinical decision rule for safe exclusion of traumatic brain injury without neuroimaging in head-injured ED patients who take anticoagulant medications. The objectives are to: 1. Derive and externally validate a new highly sensitive and maximally specific clinical decision rule for the exclusion of traumatic brain injury in head-injured ED patients who take anticoagulant medications; and, 2. Estimate the sensitivity and specificity of existing head injury clinical decision rules in head-injured ED patients who take anticoagulant medications.

NCT ID: NCT05337618 Recruiting - Clinical trials for Traumatic Brain Injury

Improving Neurotrauma by Depolarization Inhibition With Combination Therapy (INDICT)

INDICT
Start date: December 16, 2022
Phase: Phase 2
Study type: Interventional

This study is a randomized Phase 2 trial to determine the feasibility of real-time electrocorticographic monitoring of spreading depolarizations (SD) to guide implementation of a tier-based protocol of intensive care therapies, aimed at SD suppression, for the management of patients who have undergone acute operative treatment of severe traumatic brain injury.

NCT ID: NCT05326100 Recruiting - Clinical trials for MTBI - Mild Traumatic Brain Injury

Use of Virtual and Augmented Reality Devices in Vestibular Physical Therapy for mTBI

VR4VPT
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Rapidly evolving virtual reality (VR) and augmented reality (AR) technologies are being incorporated by many large-scale industries, and the medical field is no exception. One area that has gained significant attention in recent years is virtual rehabilitation which allows physical therapists to leverage state-of-the-art immersive virtual environments to uniquely address functional deficits in patients who are unresponsive to conventional treatment techniques. Advanced VR and AR technologies are now available in commercially available small-scale, mobile head-mounted displays which can be readily used in outpatient clinic settings and possibly at home. The aim of this study is to determine whether advanced VR- and AR-based physical therapy improves functional status and reduces self-reported symptoms in individuals experiencing vestibular disorders secondary to mild traumatic brain injury (mTBI). Study participants will be randomized into treatment groups: 1) conventional therapy, 2) therapy performed using a large-scale VR system (the Computer Assisted Rehabilitation Environment or CAREN), 3) therapy performed using a mobile AR. Upon completion of treatment, groups will be compared to determine functional outcome improvements with respect to static and dynamic balance as well as reduction of vestibular symptoms.

NCT ID: NCT05323149 Recruiting - Clinical trials for Inflammatory Response

Tranexamic Acid in Traumatic Brain Injury

Start date: May 18, 2022
Phase: Phase 3
Study type: Interventional

In this study, our aim is to investigate the role of tranexamic acid for modulating the inflammation in patients with traumatic brain injury (TBI).

NCT ID: NCT05309005 Recruiting - Stroke Clinical Trials

Virtual Reality and Social Cognition After Acquired Brain Injury

Start date: September 15, 2022
Phase:
Study type: Observational

The study aim is to improve assessment and understanding of social cognitive impairment after acquired brain injury by developing and validating a virtual reality version of The Awareness of Social Inference Test (TASIT). It is expected that the VR version of the test has comparable or better psychometric properties than the video version, and that it has improved relevance to everyday social skills. It is also expected that the VR version taxes cognitive functions more than a desktop version with identical content as the VR version.

NCT ID: NCT05307640 Recruiting - Trauma, Brain Clinical Trials

Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers of Acute Moderate to Severe Traumatic Brain Injuries

CG-Well
Start date: August 16, 2021
Phase: N/A
Study type: Interventional

After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. Periods of care transitions, such as ICU discharge, are most difficult. The majority (93%) of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information or practical skills to either survivors, or to long-term caregivers (>6 months post injury), rather than education, support, and skill-building that the new caregiver may use proactively that will benefit the dyad acutely after injury. The Aims of this proposal are to: (1) Determine feasibility, satisfaction, and data trends of CG-Well; and (2) Understand how baseline psychosocial risk factors affect response to CG-Well compared to an Information, Support, and Referral control group. To accomplish this, I will first enroll 6-10 caregivers and tailor CG-well until each finds the intervention acceptable, appropriate, and feasible. I will then enroll 100 (50/group) dyads and determine satisfaction ratings, recruitment, retention, and treatment fidelity of CG-Well. Additionally, I will determine if caregivers report reductions in depressive symptoms and improvements in life changes as a result of improvements in task difficulty and threat appraisal in CG-Well compared to ISR at six months. Information obtained in Aims 1 and 2 will be used to plan a larger Phase III trial of CG-Well. Completing these Aims and the training plan will improve outcomes of caregivers and downstream outcomes of survivors of msTBI, and provide me with the skillset necessary to become an independent researcher who can develop and test high-impact, high-fidelity, sustainable interventions.

NCT ID: NCT05303259 Recruiting - Brain Injuries Clinical Trials

Effect of Bevacizumab on Asymptomatic Radiotherapy-induced Brain Injury

BRAIN
Start date: November 1, 2021
Phase: Phase 2
Study type: Interventional

To investigate the effect of Bevacizumab on asymptomatic radiotherapy-induced brain injury patients with head and neck cancer.

NCT ID: NCT05302245 Recruiting - Caregivers Clinical Trials

A Longitudinal Examination of Unpaid Caregivers of Acquired Brain Injury (ABI) Survivors in Nova Scotia

CaringForwrd
Start date: October 30, 2020
Phase:
Study type: Observational

The purpose of the present study is to follow unpaid caregivers of ABI survivors in Nova Scotia over time to learn more about their experiences. The study is funded by the Government of Nova Scotia (i.e. Department of Health and Wellness). The present longitudinal cohort study will help increase knowledge about ABI caregivers at a provincial level. Findings will also be used in developing future interventions to help caregivers in this population. The goals of the research study are: 1. To understand the natural experiences of unpaid caregivers over time. More specifically, the investigators hope to learn about the experiences of unpaid caregivers of acquired brain injury survivors in Nova Scotia. 2. To examine the connection between study demographic variables (e.g. the amount of time spent caregiving in hours per week), and psychological outcome variables (e.g. caregiver burden). 3. To learn about the relationship between psychological outcome variables (e.g. psychological distress and savouring). 4. To provide a platform for future studies using the Trials within Cohort (TwiC) study design.