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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT04068883 Completed - Concussion, Mild Clinical Trials

Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar

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

The purpose of the study is to monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football and soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the efficacy of device to reduce alterations in brain structure relative to amount and magnitude of sustained head impacts. Finally, to show that DTI efficacy and safety results can be prospectively confirmed in a multi-school investigation. Test the null hypotheses of no difference between collar users and non-collar users changes from baseline to end of season for: - Primary: Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL. - Secondary: Alterations in pre-defined DTI metrics is explained by the number of hits, the hit intensity, and the intensity per head impact over the season non-collar users. In addition, secondary analytics on data derived from injury surveillance (musculoskeletal, concussion and symptom/severity scores), behavioral (Trail Making, Postural Sway, Flanker, Task-switching, Near Point Convergence, ADHD and King Devick) or imaging (DTI, fMRI, T1, T2, and MRS) will be evaluated.

NCT ID: NCT04057989 Completed - Analgesia Clinical Trials

Retrospective Evaluation of Ketamine Effectiveness for the Treatment of Acute Battlefield Related Pain

Start date: August 2014
Phase:
Study type: Observational

Using a retrospective review of records, we will conduct a multivariate analysis to examine the relationship between exposure to ketamine, as an analgesic agent in combat related trauma care, the use of additional opioid pain medications, and patient reported pain levels.

NCT ID: NCT04056312 Completed - Clinical trials for Traumatic Brain Injury

Modified Story Memory Technique (mSMT) in Persons With TBI

Start date: June 29, 2016
Phase: N/A
Study type: Interventional

The current RCT is designed to: 1. test the efficacy of the group based mSMT in persons with TBI on NPE, the current gold-standard for measuring memory functioning 2. assess the effectiveness of the group mSMT on more global measures of everyday life, including an objective measure shown through our previous work to be sensitive to memory changes following the mSMT, as well as additional questionnaires to be completed by both the participant and a significant other 3. evaluate the changes in brain functioning following treatment with the mSMT via fMRI and 4. evaluate the long-term effects of the treatment protocol. To accomplish these goals investigators will conduct a double-blind, placebo-controlled, RCT, applying the group mSMT to a sample of 60 participants with moderate to severe TBI (30 treatment; 30 control).

NCT ID: NCT04044456 Completed - Clinical trials for Mild Traumatic Brain Injury

Combining Attention and Metacognitive Training to Improve Goal Directed Behavior in Veterans With TBI

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Veterans with mild traumatic brain injury continue to deal with symptoms that interfere with their ability to engage in productive activities. In combination with other psychosocial difficulties, impairments are found in cognition, such as attention and executive function. Few interventions are available to treat attention in Veterans with mTBI. Of the interventions available, none rigorously train attention combined with strategy training. This project will innovatively combine a strategy training called Goal Management Training with computerized attention training to improve tests of problem solving, attention and functional tasks compared to a control group.

NCT ID: NCT04043429 Completed - Clinical trials for Brain Injuries, Traumatic

Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects

Start date: January 2003
Phase: Phase 2
Study type: Interventional

Visual field defects (VFD) are a frequent effect of cerebral lesions especially after posterior cerebral artery stroke. The present study was conducted to compare effects of vision restoration training (VRT) and compensation training (Visual Exploration Training, VET) on visual field performance.

NCT ID: NCT04035655 Completed - Stroke Clinical Trials

Sub-study of the NEURODOC Project : Neurophysiological Evaluation of a Routine Care Open Label tDCS Session

Neurodoc
Start date: October 2015
Phase: N/A
Study type: Interventional

Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some Minimally Conscious State (MCS) patients, and in some Vegetative State (VS) patients. However the mechanisms by which tDCS improves consciousness are poorly understood and the electrophysiological effects of such a stimulation have never been studied in disorders of consciousness patients. In this study, the investigators will use detailed clinical examinations and electrophysiological assessments (quantitative high-density EEG and event-related potentials) to assess the effect of a open-label single session of left dorsolateral prefrontal cortex tDCS stimulation administered as routine care.

NCT ID: NCT04034771 Completed - Clinical trials for TBI (Traumatic Brain Injury)

The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol

Start date: January 1, 2018
Phase: Phase 3
Study type: Interventional

This study assess the effect of administration of exogenous melatonin as adjuvant to propofol on the level of sedation and consequently the rate of propofol infusion.

NCT ID: NCT04032509 Completed - Clinical trials for Mild Traumatic Brain Injury

A Study of Biomarkers of Mild Traumatic BRAIN Injury

BRAINI
Start date: August 10, 2019
Phase:
Study type: Observational

Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

NCT ID: NCT04026581 Completed - Cerebral Palsy Clinical Trials

Real World Testing of a Brain-Computer Interface

Start date: June 5, 2019
Phase:
Study type: Observational

The goal of this project is to test a new AAC-BCI device comparing gel and dry electrode headgear used for communication while providing clinical care. Innovative resources will be employed to support the standard of care without considering limitations based on service billing codes. Clinical services will include AAC assessment, AAC-BCI device and treatment to individuals with minimal movement due to amyotrophic lateral sclerosis (ALS), brain stem strokes, severe cerebral palsy, traumatic brain injury (TBI) and their family support person. This is a descriptive study designed to measure and monitor the communication performance of individuals using the AAC-BCI, any other AAC strategies, their user satisfaction and perceptions of communication effectiveness, and the satisfaction of the family support persons.

NCT ID: NCT04018989 Completed - Stroke Clinical Trials

Validation of the FOUR Coma Scale in Russia.

FOUR-RUS
Start date: July 20, 2019
Phase:
Study type: Observational

The purpose of this study is to examine the validity of the Russian version of the FOUR Full Outline of UnResponsiveness (hereafter FOUR) scale in adult ICU patients with an acute cerebral insufficiency clinic (hereinafter referred to as OTSN). Compare the accuracy and predictive significance of FOUR when used by an ICU specialist, a neurologist, nursing staff, during bedside and telemedicine Examinations.