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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT02148367 Withdrawn - Clinical trials for Traumatic Brain Injury

Effect of Recombinant Erythropoietin on Numbers of Circulating Endothelial Progenitor Cells in Subacute TBI

TBI-EPO
Start date: September 2014
Phase: Phase 2
Study type: Interventional

- Traumatic brain injury (TBI) is the leading cause of death and disability in people under age 45 in industrialized countries. Significant numbers of US veterans from the wars in Iraq and Afghanistan return with TBI. However, to date, there are no specific neuroprotective treatment options with proven clinical efficacy. - Erythropoietin (EPO) is approved by the FDA to treat anemia and has comprehensive preclinical data supporting its neuroprotective and neuroregenerative efficacy following traumatic (TBI) and a wide range of other acquired brain insults. Injury to small and medium-sized cerebral blood vessels is a well recognized consequence of TBI. EPO increases production of endothelial progenitor cells (EPCs) and promotes angiogenesis and neovascularization after TBI. EPO also promotes neurogenesis and improves functional recovery in animals after experimental stroke and TBI. Neovascularization is coupled with neurogenesis, and augmentation of both processes by EPO may result in lessened cognitive deficits. Neovascularization by EPO may prevent post-traumatic deficits in cerebrovascular reactivity (CVR), which can be measured noninvasively using magnetic resonance imaging (MRI). - This proposal is for a randomized, placebo-controlled pilot clinical trial designed to obtain data on the effects of EPO in humans with persistent post-concussive symptoms after TBI. The primary objective is to evaluate effect of 4 week administration of recombinant erythropoietin on numbers of circulating endothelial progenitor cells in patients with persistent symptoms during the subacute period after TBI. This information will guide the design of a future definitive study.

NCT ID: NCT02134041 Recruiting - Alzheimer Disease Clinical Trials

Amyloid Accumulation After Mild Traumatic Brain Injury

TBI
Start date: October 2012
Phase:
Study type: Observational

We are extending the researches of Taiwan neurosurgery traumatic brain injury (TBI) database which is led by Professor WT Chiu in Taipei Medical University and will recruit mild TBI (mTBI) participants who have ever been registered in the database. This database has been established for over 15 years and contains the information of over 150000 patients. It is one of the largest TBI database in the world. TBI usually results from traffic accidents, falls or violence events. Most of the victims are young people and the victims suffer from life-threatening and mental-physical deficits. Mild TBI (mTBI) usually was neglected before because its symptoms, signs are mild and mTBI patients usually were not obtained enough initial treatment. Therefore, mTBI might result in long-term cognitive and affective impairments, such as depression, indifference, anxiety, memory impairment, loss of attention and executive function. These late effects not only decrease the life quality of patients and their family but also increase the social and medical burden. Recent epidemiology studies have pointed out that TBI would increase the risk for dementia, especially Alzheimer disease (AD) by 2-4 times. However, the association between TBI severity, number of repeats, genetic factors and onset of AD remains further investigation. Amyloid-β (Aβ) plaques and neurofibrillary tangles are the pathological hallmarks for AD. Accumulation of Aβ is considered to be the first step of pathophysilogy of AD. Compelling researches have supported TBI accelerates the formation and accumulation of Aβ. These findings could link TBI with AD but the previous researches had limitations. There was lack of mTBI pathology data so the impacts of mTBI on Aβ accumulation were still obscure. By amyloid-PET, we could study the effects of mTBI on the accumulation of Aβ and this tool could be helpful for understanding the real impacts and pathophysiological mechanisms of mTBI on AD.

NCT ID: NCT02129361 Completed - Clinical trials for Traumatic Brain Injury

Screening and Brief Intervention for Substance Misuse Following Traumatic Brain Injury

Start date: March 2014
Phase: N/A
Study type: Interventional

This study is investigating one way to improve health and healthy habits after traumatic brain injury (TBI). The primary goal of this study is to determine if a brief intervention accommodated for persons with moderate or severe TBI is effective in reducing alcohol misuse during the year following injury. It is hypothesized that an adapted Screening, Education and Brief Intervention (adapted SBI) will reduce the number of alcoholic drinks consumed per week over the year following discharge from inpatient rehabilitation, in comparison to a Screening and Education Attention Control condition (SEA control).

NCT ID: NCT02119182 Completed - Clinical trials for Traumatic Brain Injury

Transforming Research and Clinical Knowledge in Traumatic Brain Injury

TRACK-TBI
Start date: March 2, 2014
Phase:
Study type: Observational

The overall goal of Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study is to determine the relationships among the clinical, neuroimaging, cognitive, genetic and proteomic biomarker characteristics for the entire spectrum of TBI from concussion to coma. TRACK-TBI will validate biomarkers and outcome measures for clinical trials, advance diagnostic and prognostic models for TBI and improve clinical trial design. The Investigators are enrolling patients within 24 hours of injury who present to a TRACK-TBI site with a brain injury that meets ACRM criteria and receives a clinically indicated head CT.

NCT ID: NCT02114775 Completed - Clinical trials for Traumatic Brain Injury

Growth Hormone or Sildenafil as Therapies for Fatigue in Mild- Traumatic-brain-injury (MTBI)

Start date: December 12, 2014
Phase: Phase 1
Study type: Interventional

The overall goal is to determine whether perceptual or performance fatigue can be reduced in MTBI patients with and without growth hormone (GH) deficiency by treating them in a crossover fashion based upon GH status. A battery of functional, fatigue, cognitive, imaging and blood flow tests will be performed to assess the efficacy of the two drug interventions, Growth hormone and Sildenafil.

NCT ID: NCT02110290 Completed - Cerebral Palsy Clinical Trials

Effects of an Adapted Ski/Snowboarding Program on Quality of Life in Children With Physical Disabilities

Start date: October 2010
Phase:
Study type: Observational

This study is assessing quality of life in children with a physical disability who participate in the Children's Hospital Colorado Hospital Sports Program (HSP), where children with physical disabilities are able to participate in more organized sports and active programs with the use of adaptive equipment. This study would assess a child's self reported and parent perceived quality of life before and after child participation in HSP for the winter season. The investigators aim to determine the level of child and parent happiness and satisfaction in specific quality of life aspects including: physical activities and health, feelings, moods, self perception, home life, friends, school, learning and bullying. The investigators believe that children with any physical disability will have a more satisfactory reported quality of life after participating in HSP for one or many years.

NCT ID: NCT02100150 Terminated - Concussion Clinical Trials

A Safety and Efficacy Study of NNZ-2566 in Patients With Mild Traumatic Brain Injury (mTBI)

Start date: September 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the treatment of mTBI in adolescents and adults.

NCT ID: NCT02091739 Completed - Parkinson's Disease Clinical Trials

Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions

SIAXI
Start date: April 2014
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate the efficacy and safety of two different dose levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary flow rate, and the severity and frequency of chronic troublesome sialorrhea that occurs as a result of various neurological conditions in adult subjects.

NCT ID: NCT02088099 Completed - Clinical trials for Traumatic Brain Injury

Mayo Clinic Traumatic Brain Injury Model System Center: The CONNECT Trial

CONNECT
Start date: March 2014
Phase: N/A
Study type: Interventional

Mayo Clinic has been funded by the National Institute on Disability Independent Living & Rehabilitation Research (NIDILRR) as a Traumatic Brain Injury (TBI) Model System Center continuously since 1998. We have successfully competed for this funding because we consistently produce high quality research and because we provide comprehensive team-based rehabilitation services to people with TBI and their families over the continuum of care that is associated with superior outcomes. Lack of access to specialized TBI care is the most common need identified by individuals after they are hospitalized for TBI. The upper Midwest has some of the highest populations of rural dwellers, the elderly, and Native Americans, all of whom have a high risk for TBI and are more likely to have limited access to rehabilitation services after acute care. Explosive advances in communication technology have brought tele-medicine to the forefront of health care. The CONNECT trial will test the effectiveness of using modern technologies - such as phone consultation and other telehealth communication systems - to deliver specialized brain rehabilitation resources remotely to patients and providers in the upper Midwest. The groups targeted by the CONNECT trial are: - Individuals recently hospitalized with TBI; - Their families; - Their local health care and other providers (primary care providers, psychologists, therapists, social service providers, job counselors). The CONNECT trial is the first study of this scope - in 4 upper Midwest states (MN, IA, ND, and SD), 3 health systems (Mayo Clinic, Altru Health System in ND, Regional Health in SD), and 2 state Departments of Health (IA, MN) - using electronic technology to see if outcome can be improved by providing care with no face-to-face contact. The trial will study whether outcomes over three years are different in the group receiving this remotely provided model of care compared to a matched group that receives usual care in their communities. The desired long term outcome of this study is to increase our capacity to provide care and to reduce barriers to accessing specialized TBI rehabilitation services faced by individuals with TBI and their families.

NCT ID: NCT02084329 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Balance and Mild Traumatic Brain Injury: The Effect of a Weighted Compression Vest

Start date: March 2014
Phase: N/A
Study type: Interventional

After a mild traumatic brain injury (mTBI) people often report balance problems. At Parkwood hospital we have noticed that balance is improved when patients with mTBI wear a weighted compression vest. This follow up pilot study looks at the immediate effects of weighted compression vests on participants with altered balance after mTBI. Participants will be recruited from the Ministry of Health Outpatient Acquired Brain Injury (ABI) Program wait list. Then each participant will perform a series of balance and walking tests under 2 conditions : 1) wearing a weighted compression vest , 2) not wearing a weighted compression vest. It will be randomized whether participants wear the vest on the first or second testing day. Participants will also be asked how confident they are about their balance and how anxious they felt performing the assessments after each testing session. We hypothesize that the weighted compression vest will improve fatigue and anxiety immediately and 24 hours after performing a complex task, and will improve static and dynamic balance, gait variability, and walking speed in patients with mTBI, during the tasks.