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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT04688255 Recruiting - Clinical trials for Brain Injuries, Traumatic

Mobile Subthreshold Exercise Program for Concussion--R01

MSTEP-R01
Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Approximately 1.9 million youth sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) such as headache, dizziness, and difficulty focusing that continue for weeks or months. PPCS results in greater utilization of sub-specialty care and can impact immediate and long-term social development, cognitive function and academic success. Previous recommendations for treating PPCS have focused on cognitive and physical rest, but more recently guidelines have shifted based on new research suggesting the benefit of rehabilitative exercise for PPCS. The rationale behind using exercise to treat youth with concussion is that gradually increasing physical activity facilitates return to full function. Rehabilitative exercise has since become one of the most common approaches to treating youth with PPCS, but access is challenging since most programs require weekly centralized visits with a concussion specialist. To bridge this gap, the investigators developed a telehealth-delivered approach to treat PPCS, utilizing physical activity trackers (Fitbits) and weekly video conferences with trained research staff. They then conducted a series of pilot studies with this approach, finding excellent feasibility, acceptability, and evidence for more rapid declines in concussive symptoms compared to controls. The investigators also found preliminary evidence that mechanisms behind this intervention may stem from both physiologic processes due to increased moderate-to-vigorous physical activity (MVPA) and psychologic processes such as reducing fear- avoidance of concussive symptoms. They now propose a fully-powered randomized controlled trial (RCT) to asses the efficacy of the "Mobile Subthreshold Exercise Program" (M-STEP) for treating youth with PPCS.

NCT ID: NCT04666766 Recruiting - Clinical trials for Brain Injuries, Traumatic

Detecting Traumatic Intracranial Hemorrhage With Microwaves and Biomarkers

MBI01
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

This study will evaluate if traumatic intracranial hemorrhage can be safely ruled out by using a microwave scanner (MD100) in conjunction with a combination of different brain biomarkers analyzed in serum.

NCT ID: NCT04642443 Recruiting - Clinical trials for Traumatic Brain Injury

Evaluate the SENSE Device's Ability to Monitor and Detect Intracranial Hemorrhage

Start date: December 23, 2020
Phase: N/A
Study type: Interventional

This study is a two-stage, pivotal, prospective, non-randomized, multi-center, within patient comparison of the SENSE device and the standard diagnostic test, head CT scan in patients with a diagnosis of primary spontaneous ICH or traumatic intracranial bleeding for the detection and monitoring of intracranial hemorrhages.

NCT ID: NCT04610697 Recruiting - Depression Clinical Trials

Cognitive Remediation in Forensic Mental Health Care

CRFMHC
Start date: February 10, 2020
Phase: N/A
Study type: Interventional

Forensic patients often display cognitive deficits, particularly in the domain of executive functions, that represent a challenge to forensic rehabilitation. One empirically-validated method to train executive functions is cognitive remediation, which consists of cognitive exercises combined with coaching. This trial investigates whether cognitive remediation can improve cognitive, functional, and clinical outcomes in forensic inpatients.

NCT ID: NCT04603443 Recruiting - Clinical trials for Traumatic Brain Injury

SmART-TBI: Supplementation With Amino Acid Rehabilitative Therapy in TBI

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

The most persistent and disabling postconcussive symptoms following mild traumatic brain injury (mTBI) are sleep disturbances and cognitive dysfunction, with few tractable interventions currently available. Here, a novel therapy will be tested consisting of dietary supplementation with branched chain amino acids (BCAA), based on the study team's previous preclinical work showing restoration of glutamate neurotransmitter balance in sleep and memory circuits. Supplementation with Amino acid Rehabilitative Therapy in TBI (SmART-TBI) is a randomized, placebo-controlled, double-blinded, exploratory clinical trial of BCAA intended to establish the feasibility, acceptability, and limited efficacy of long-term BCAA to improve sleep and cognition in Veterans with mTBI. These results will inform the optimal study design of a future, full-scale randomized controlled trial, including the identification of the proper dose and duration of BCAA to improve sleep and the potential subpopulations of Veterans with mTBI that may benefit the most.

NCT ID: NCT04597879 Recruiting - Trauma Clinical Trials

Impact of Severe Brain Injury on Neuro-vascular and Endothelial Regulation of Peripheral Microcirculation.

MicroTC
Start date: August 1, 2021
Phase:
Study type: Observational

Severe brain injury (SBI) is one of the world's leading causes of death and disability in young adults, but its peripheral vascular consequences in humans are poorly understood. This prospective, monocentric, pathophysiological study aims to investigate differences in vasoreactivity in the anterior aspect of the contralateral forearm at the most injured cerebral hemisphere between patients with severe head trauma and patients with severe trauma without associated brain injury matched on sex and age (+/- 5 years).

NCT ID: NCT04588311 Recruiting - Clinical trials for Traumatic Brain Injury

ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients

EPO-TRAUMA
Start date: November 9, 2020
Phase: Phase 3
Study type: Interventional

The EPO-TRAUMA study is a prospective, multi-centre, double-blind, phase III, randomised controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients. 2500 mechanically ventilated ICU patients admitted with a primary trauma diagnosis presenting to the ICU will be recruited into the study from participating study centres in Australia, New Zealand, Europe, and Saudi Arabia.

NCT ID: NCT04576715 Recruiting - Clinical trials for Mild Traumatic Brain Injury

TBI Evaluation and Management (TEaM)

TEaM
Start date: August 19, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate a multi-disciplinary, multi-setting intervention with the goal of improving outcomes for children who have experienced a mild traumatic brain injury (mTBI). The project aims to improve and support mTBI diagnosis and management, and improve critical decision making by clinicians during their interaction with the injured child, their family, and their school.

NCT ID: NCT04573413 Recruiting - Clinical trials for Traumatic Brain Injury

Repetitive Transcranial Magnetic Stimulation in Traumatic Brain Injury

Smart trace
Start date: March 30, 2021
Phase: N/A
Study type: Interventional

Randomized Controlled Trial (RCT) aiming at assessing the efficacy of a novel rehabilitation protocol, based on repetitive transcranial magnetic stimulation (r- TMS) in combination with a conventional cognitive treatment (CCT). The protocol will be statistically compared to the same CTT administered without the r-TMS in a sample of traumatic brain injury patients (age between 18 and 80 years) with left hemispatial Neglect.

NCT ID: NCT04565119 Recruiting - Clinical trials for TBI (Traumatic Brain Injury)

Biomarkers in the Brain Oxygen Optimization in Severe Traumatic Brain Injury Trial

BioBOOST
Start date: December 20, 2020
Phase:
Study type: Observational

BioBOOST is a multicenter, observational study of the effect of derangements in brain physiologic parameters on brain injury biomarker levels in patients with severe traumatic brain injury.