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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT02647996 Completed - Clinical trials for Disorder of Consciousness

Functional Connectivity Measurement After Severe Traumatic Brain Injury

Connectivite
Start date: March 2015
Phase:
Study type: Observational

To compare functional connectivity after severe traumatic brain injury (TBI) between a group of post-comatose TBI with restored consciousness and a group of post-comatose TBI with persistant disorder of consciousness at admission in rehabilitation

NCT ID: NCT02646176 Completed - Brain Injuries Clinical Trials

Comparative Effectiveness of Rehabilitation Interventions for Traumatic Brain Injury

TBI-CER
Start date: October 2008
Phase:
Study type: Observational

Traumatic brain injury (TBI) is increasingly recognized as a significant public health issue, but the most effective rehabilitation methods have yet to be identified. The Institute of Medicine and the Agency for Healthcare Quality and Research sponsored systematic reviews of evidence for comparative effectiveness of rehabilitation interventions for TBI. Both reviews concluded that substantially more research is needed to identify interventions best suited for different individuals. The practice-based evidence (PBE) approach employed to create the data used in the proposed study was a research method recommended to provide greater clarity, along with use of patient-centered outcomes obtained over a longer period of time than used in previous studies. The following specific aims will be addressed in the proposed study: 1. Determine the comparative effectiveness of different therapeutic approaches used in inpatient TBI rehabilitation after statistically adjusting for patient need and ability to benefit from various approaches. Investigators hypothesize: 1.1. Patients who receive a greater proportion of therapy time in Advanced Training (versus Standard of Care) will achieve better outcomes than similar patients who receive a lesser proportion of treatment time in Advanced Training. 1.2. Patients with the greatest initial levels of disability will experience larger effects from Advanced Training therapeutic approaches in comparison to the effects experienced by patients with less disability at admission. 1.3. Patients who receive a greater proportion of therapy in contextualized treatment (versus decontextualized) will achieve better outcomes than similar patients who receive a lesser proportion of time in contextualized treatment. 2. Determine the comparative effectiveness of difference in the delivery of inpatient rehabilitation therapies, after statistically adjusting for patient need and ability to benefit. Investigators hypothesize: 2.1 The level of effort that patients are able to apply in treatment moderates the effectiveness of time in treatment. 2.2 Family involvement in treatment is associated with better outcomes. Data will be drawn from the database established for the TBI Practice-Based Evidence Study (TBI-PBE Study). Data on 2130 persons who received inpatient TBI rehabilitation at any of 10 sites (9 in US, 1 in Canada) were obtained for the study. Detailed longitudinal data were collected prospectively on rehabilitation therapies (with point of care data completed for every clinical encounter), course of recovery, person and injury characteristics and outcomes during and after rehabilitation. Advanced analytic methods (e.g. propensity scores, generalized linear mixed models) will be used to compare the effects of different rehabilitation interventions on outcomes at discharge and during the 9 months following rehabilitation.

NCT ID: NCT02645552 Not yet recruiting - Clinical trials for Brain Injuries, Traumatic

Pre-hospital Administration of Tranexamic Acid for Moderate and Severe Traumatic Brain Injury

Start date: January 2016
Phase: Phase 3
Study type: Interventional

This study is a prospective single-centre randomized trial to compare the effect of tranexamic acid versus placebo in the pre-hospital management of patients with moderate and severe traumatic brain injury.

NCT ID: NCT02639923 Completed - Clinical trials for Brain Injuries, Traumatic

The Clinical Relevance of Micro RNAs in Mild Traumatic Brain Injury

mRNA
Start date: January 2016
Phase:
Study type: Observational

The aim of this study is to investigate the early serum measurement (<6h after injury) of mRNA miR Let-7i, miR-16 and miR-92 in patients with MHI and intracranial traumatic lesions (CCT pos.) as compared to those in patients with MHI without intracranial traumatic lesions (CCT neg.). S100B serum levels will be measured in both groups. The usual risk factors for the occurrence of an intracranial hematoma (diagnostic algorithm) will be recorded. Additionally, a group of healthy individuals will serve as a control group.

NCT ID: NCT02634944 Completed - Clinical trials for Mild Traumatic Brain Injury

The Use of the VOMS Tool With Military Personnel to Track mTBI Recovery and RTD Status

Start date: March 16, 2018
Phase: N/A
Study type: Interventional

The purpose of the proposed project is to determine if the VOMS is an effective screening tool to identify and track recovery of vestibular and ocular motor impairment and symptoms following mTBI, that corpsman-level medical personnel can successfully implement in combat and non-combat environments. A second purpose of the project is to determine if impairment and symptoms on the VOMS is more pronounced following blast compared to blunt mTBI.

NCT ID: NCT02629588 Completed - Brain Injuries Clinical Trials

Effectiveness of Sensory Stimulation for Person in a Coma or Persistent Vegetative State After Traumatic Brain Injury

Start date: January 2015
Phase: N/A
Study type: Observational

Appraised the empirical evidence of effectiveness of sensory stimulation to improve arousal and alertness for persons in a coma or persistent vegetative state after traumatic brain injury (TBI). Databases were searched and nine articles met inclusion criteria.

NCT ID: NCT02623218 Completed - Clinical trials for Traumatic Brain Injury

Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury

TREAT-TBI
Start date: November 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effects of acupuncture on cerebral blood flow (CBF) and blood biomarkers during the acute 10-day window following traumatic brain injury, to determine if those changes correlate with changes in biomarkers of brain health, neuropsychological testing, and symptomatic presentation.

NCT ID: NCT02618226 Completed - Clinical trials for Traumatic Brain Injury

Optic Nerve Ultrasound in Severe Traumatic Injury

ONUS-TBI
Start date: January 2016
Phase:
Study type: Observational

Prospective study of diagnostic accuracy of optic nerve sheath diameter measurement (index study) in traumatic brain injury with simultaneous invasive intracranial pressure monitoring as the reference standard.

NCT ID: NCT02615535 Completed - Clinical trials for Traumatic Brain Injury

Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury

Start date: December 2015
Phase: N/A
Study type: Interventional

Spaulding Rehabilitation Hospital is conducting a research study evaluating the effectiveness of the brain-training product, MUSE, an EEG-guided neurofeedback device designed to assist in cultivating a relaxed, attentive state of mind during meditation. The investigators study aims to evaluate whether such a tool could be useful in treating persistent traumatic brain injury symptoms such as inattention, impulsivity, irritability, or dysregulated mood.

NCT ID: NCT02613936 Completed - Depression Clinical Trials

Transcranial Direct Current Stimulation for the Treatment of Deficits After Traumatic Brain Injury

Start date: September 2015
Phase: N/A
Study type: Interventional

Patients with mild-moderate traumatic brain injury (TBI) sustained between 3 months and 5 years ago with prolonged postconcussive symptoms will be recruited. On Day 1 of the study they will undergo neuropsychological (NP) testing. They will then undergo 10 days of Left dorsolateral prefrontal (DLPFC) anodal transcranial direct current stimulation (TDCS) (active or sham) combined with cognitive training. On day 10 NP testing will be obtained again. On Day 30, NP testing will be repeated a 3rd time. At 6 months and 1 year, quality of life, depression, and post concussive symptoms will be assessed.