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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT02592291 Recruiting - Cerebral Palsy Clinical Trials

Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions

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

This study will assess the benefits of using mobile health system designed for individuals with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and self-management skills compared to those who receive standard of care only.

NCT ID: NCT02589509 Withdrawn - Clinical trials for Brain Injuries, Traumatic

Cognitive Rehabilitation and Brain Activity of Attention Control in TBI

Start date: December 1, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to test an innovative combination of direct-attention training and metacognitive training in the treatment of attention impairments in Veterans with moderate-to-severe traumatic brain injury (TBI) who report experiencing attentional problems. Enrolled participants will be randomized to receive either the direct-attention training or metacognitive training first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks and a post-treatment 4 weeks later. In addition to the rehabilitation treatments, participants will also perform measures of complex functional activities (e.g., independent activities of daily living or IADLs) and neurocognitive tests of attention-control functions. Participants will also perform an attentional task that probes the function of three different attentional systems while brain wave activity (i.e., electroencephalography or EEG) is being recorded in order to assess changes in brain function that may be improved by the rehabilitation approach. Planned enrollment will be 36 Veterans.

NCT ID: NCT02589223 Terminated - Clinical trials for Traumatic Brain Injury With Prolonged Loss of Consciousness

A Trial to Determine the Feasibility and Effectiveness of Early Multisensory Stimulation Intervention in Patients in the Trauma-Neurosurgical Intensive Care Unit (TNICU) Following Severe Acquired Brain Injury

Start date: February 16, 2017
Phase: N/A
Study type: Interventional

St. Michael's Hospital (SMH) provides service to individuals with some of the most severe brain injuries and intensive care needs in Canada. These patients often require prolonged intensive care admissions, lengthy hospital stays, involvement of many health professionals, and long-term support for ongoing care requirements. Many hospitals face resource limitations, specifically involving the health disciplines and their ability to provide frequent intervention. It has been proposed that multisensory stimulation (i.e. exposing the patient to various sights, sounds, smells, etc.) in the early stages of brain injury recovery may result in improved responsiveness/cognitive function. Previous research has indicated a potential benefit for early multisensory stimulation intervention for patients with severe brain injury. However there is still not enough conclusive evidence to confirm whether the intervention is truly effective. The investigators are proposing a pilot randomized controlled study (placebo-controlled, double-blinded) to determine the feasibility and examine the effectiveness of early multisensory stimulation with patients following severe brain injury who remain in a coma, vegetative state, or minimally conscious state. Eligible patients will be randomized to a control group (standard care + family/caregiver education) or an intervention group (standard care + family/caregiver education + early sensory intervention). Data regarding number of patients enrolled, amount of intervention completed, percentage of outcome data collected, patient's level of responsiveness and cognitive function will be collected before and after the intervention period, using several outcome measures. The investigators hope to determine the feasibility of conducting this type of study within this clinical setting and the effectiveness of multisensory stimulation with this patient population.

NCT ID: NCT02561403 Completed - Clinical trials for TBI (Traumatic Brain Injury)

Brain Aging in Veterans (BRAVE) Training: A Cognitive Training Pilot Trial in Older Veterans With Traumatic Brain Injury

Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to conduct a pilot trial investigating cognitive training in older Veterans with a history of traumatic brain injury (TBI) to assess training effects, acceptability of training to participants, and to explore whether other factors influence training effects.

NCT ID: NCT02556177 Completed - Clinical trials for Traumatic Brain Injury

Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2

mTBI-phase2
Start date: November 2015
Phase: N/A
Study type: Interventional

This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical neuropsychological assessments and GE Research Pack II advanced MR imaging in mTBI patients. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.

NCT ID: NCT02541123 Completed - Clinical trials for Traumatic Brain Injury

Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma

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

The primary objective of the clinical trial is to evaluate the effect of time on levels of Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of head injured subjects over the age of 18 presenting acutely with a Glasgow Coma Scale score 13-15 as well as in a group of uninjured control subjects.

NCT ID: NCT02525432 Active, not recruiting - Clinical trials for Brain Injuries, Traumatic

Autologous Stem Cell Study for Adult TBI (Phase 2b)

Start date: November 21, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of intravenous infusion of autologous bone marrow mononuclear cells (BMMNC) on brain structure and neurocognitive/functional outcomes after severe traumatic brain (TBI) injury in adults. The primary objective is to determine if the intravenous infusion of autologous BMMNC after severe TBI results in structural preservation of global gray matter (GM) volume and white matter (WM) volume and integrity; as well as select regions of interest in the corpus callosum. THe secondary objectives are to determine if autologous BMMNC infusion improves functional and neurocognitive deficits in adults after TBI; reduces the neuroinflammatory response to TBI; evaluate spleen size and splenic blood flow over time using ultrasound and corresponding changes in inflammatory cytokines; and infusion related toxicity and long-term follow-up safety evaluations.

NCT ID: NCT02524067 Completed - Clinical trials for Traumatic Brain Injury (TBI)

Modified Environment for Agitation in Patients With TBI

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

This study examines the effect of an intervention consisting of dynamic circadian light and sound therapy, as well as systematic information on sleep pattern, agitated behavior and functioning level.

NCT ID: NCT02509689 Completed - Clinical trials for Traumatic Brain Injury

Neurofeedback Technology (GZNT) for Persistent Post-Concussive Symptoms in Soldiers

GZNT
Start date: December 2014
Phase: N/A
Study type: Interventional

A new technology called Global Z-Score Neurofeedback Technology (GZNT) has been identified that can overcome an existing barrier to the use of neurofeedback as a treatment technique in a military setting. Neurofeedback, or EEG Biofeedback, is a form of biofeedback that uses the brain's own electrical activity as the training parameter. With sufficient practice, the brain can learn to change its own activity through finely tuned feedback using computerized sounds, graphs and animations. Previous attempts at using neurofeedback as a treatment modality have been subject to a lack of standardization and have required significant expertise on the part of the provider. This new GZNT technology allows neurofeedback to be administered in a standardized and semi-automated fashion, which, if effective, will represent a significant advance toward providing this promising treatment modality to Service Members in a military or VA setting. This study will determine feasibility and preliminary evidence of efficacy for this neurofeedback technology in a pilot study of soldiers with medical issues associated with Traumatic Brain Injury (TBI). GZNT technology has the potential to provide a cost-efficient, non-invasive/non-pharmacological approach to recovery from impact and/or blast-induced brain injury, and holds promise to simultaneously address emotional symptoms that are often a part of the post-concussion symptom picture.

NCT ID: NCT02507973 Terminated - Clinical trials for Traumatic Brain Injury

Study of Airway Pressure Release Ventilation and Intracranial Pressure in Patients With Severe Traumatic Brain Injury

Start date: July 2015
Phase:
Study type: Observational

The investigators will conduct an observational crossover study. The investigators aim to recruit 50 participants with severe Traumatic Brain Injury (TBI) requiring intracranial pressure (ICP) monitoring during their stay at the Neuro Trauma ICU at the R Adams Cowley Shock Trauma Center. Overall, participants will be monitored, on average, for approximately 6-8 hours during the study period. The investigators do not anticipate the need for prolonged monitoring during the duration of their hospital stay or post hospital period.