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Brain Injuries, Traumatic clinical trials

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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: NCT05340803 Not yet recruiting - Clinical trials for TBI (Traumatic Brain Injury)

Sedation of Ventilated Traumatic Brain Injury Patients With Midazolam Alone Versus Combination With Dexmedetomidine or Magnesium Sulfate; Monitored by Ultrasonograghic Optic Nerve Sheath Diameter

Start date: November 1, 2022
Phase: Phase 3
Study type: Interventional

In TBI, there is a strong correlation between increased ICP and bad outcome. So, appropriate monitoring can be the gold standard in management of TBI. ICP can be measured by invasive and noninvasive methds. One of these noninvasive methods is bedside measurement of optic nerve sheath diameter (ONSD) by ocular ultrasonography

NCT ID: NCT05340114 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Usability Study of CEREBO® - A Novel Non-invasive Intracranial Bleed Detector

Start date: April 25, 2022
Phase: N/A
Study type: Interventional

Traumatic Brain Injury (TBI) is the leading cause of death and disability across the globe. Time from injury to treatment is the most critical factor that determines the patient's recovery. Mild TBI with no apparent symptoms are often left undiagnosed, thus delaying the treatment and hence recovery. CEREBO® is a non-invasive, rapid, near-infrared based, point-of-care device that can detect an intracranial bleed at an early stage.

NCT ID: NCT05337774 Terminated - Clinical trials for Mild Traumatic Brain Injury

Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury

Start date: June 7, 2021
Phase: Phase 1
Study type: Interventional

The main objective of this interdisciplinary study is to develop an understanding of the molecular imaging features of blast-related mild traumatic brain injury (mTBI) in military personnel, while helping to establish assessment tools that may be of use in diagnosis, determining prognosis, and in future therapeutic clinical trials. Additionally, the objective is to evaluate feasibility of [18F]PI-2620 in the assessment TBI.

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: NCT05327829 Not yet recruiting - Clinical trials for TBI (Traumatic Brain Injury)

Stimulating After Recovery From Traumatic Brain Injury

SMART
Start date: June 30, 2024
Phase: Early Phase 1
Study type: Interventional

This is a preliminary, prospective interventional study to investigate the feasibility of using transcutaneous alternating current stimulation (TACS) and transcutaneous noninvasive vagal nerve stimulation (tnVNS) after a traumatic brain injury (TBI) to improve cognitive function and decision-making.

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: NCT05315453 Completed - Clinical trials for Cognitive Impairment

Brief Telehealth Cognitive Rehabilitation Following Mild TBI

On-TRACC
Start date: December 13, 2021
Phase: N/A
Study type: Interventional

In the United States, more than a million people sustain a mild traumatic brain injury (mTBI) every year. Although many recover fully, emerging literature suggests a high number of individuals report chronic, and functionally disabling, cognitive difficulties. Among Veterans, a nationwide survey found that more than 75% of 55,000 Veterans with a history of mTBI reported persistent moderate to severe levels of forgetfulness and poor concentration. Reduced cognitive functioning following mTBI contributes to significant functional impairment, including underemployment, relationship difficulties, and reduced community integration for years post injury. Despite the significant individual and societal impact, evidence to guide interventions and treatment for this population remains limited. Even more limited are validated telehealth options for these symptoms, a critical means by which access to care can be improved, especially during the COVID-19 pandemic. The proposed pilot study will address this gap by evaluating the feasibility, acceptability, and preliminary effectiveness of a brief (5-session) cognitive rehabilitation intervention that was developed for individuals with mTBI and that will be administered over video-based telehealth technology. The development of this intervention was supported by a grant from the Department of Defense, with critical elements identified through surveys completed by clinicians and veterans with a history of mTBI, and also the clinical expertise of the team.

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.