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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT02215187 Completed - Clinical trials for Traumatic Brain Injuries

Telehealth-Education-Based Program for Military Caregivers of Injured Service Members With Head Injuries

Start date: July 2013
Phase: N/A
Study type: Interventional

The primary purpose of this research is to evaluate the impact of a telehealth-based, cognitive behavioral therapy (CBT) intervention (problem-solving training: PST) for adult informal military family/friend caregivers of OIF/OEF service members with a deployment-related TBI.

NCT ID: NCT02214212 Completed - Clinical trials for Traumatic Brain Injury

TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI

TWILIGHT
Start date: December 2013
Phase: N/A
Study type: Interventional

This study proposes to investigate how well Bright White Light Therapy will work in the acute inpatient rehabilitation units for people whom have experienced a traumatic brain injury for the purpose of treating sleep disruption. Participants will be assessed based on sleep efficiency, thinking abilities, therapy participation, and perception of fatigue/sleepiness. In previous studies dim red light has not had the same effects on function as bright white light, and will be chosen for use as a placebo. Each subject will be randomized to receive 30 minutes of either Bright White Light Therapy or Red Light Treatment each morning for 10 days. To measure the effect of this treatment, the investigators will measure the each participants sleep daily by using an actigraph watch. This watch will record movement continuously. The investigators will also measure the subjects' report of how well they slept, whether fatigue is present, and how attentive they are before and after treatment. Research Hypothesis: In persons with TBI, prospectively compare overnight sleep in a cohort exposed to morning Bright White Light with a comparison group exposed to Red Light in an acute inpatient rehabilitation setting.

NCT ID: NCT02211820 Completed - Brain Disease Clinical Trials

PET Imaging in Chronic Traumatic Encephalopathy

Start date: August 1, 2014
Phase:
Study type: Observational

Background: - Chronic traumatic encephalopathy (CTE) is a brain disease caused in part by head injury. The brain changes from CTE can only be seen at autopsy. Researchers want to test a new brain scan to help diagnose CTE in living patients. Objective: - To determine if a new type of brain scan can detect changes that occur in chronic traumatic encephalopathy. Eligibility: - Adults age 18 60 with previous head injury or participation in certain sports. Design: - Participants will be screened with: - Physical exam - Blood and urine tests - Tests of thinking, mood, and memory - 30-minute magnetic resonance imaging (MRI) brain scan. A magnetic field and radio waves take pictures of the brain. Participants will lie on a table that slides into a metal cylinder. They will get earplugs for the loud knocking sounds. - Visit 1: Participants will have a 70-minute PET scan of the brain with a small amount of a radioactive chemical. That will be injected through an intravenous tube (catheter) in each arm. A catheter will also be put into an artery at the wrist or elbow. - Participants will lie on a bed that slides in and out of a donut-shaped scanner. A plastic mask may be molded to their face and head. Vital signs and heart activity will be checked before and during the scan. - Blood and urine will be taken before and after the scan. - Participants will be checked on by phone the next day. - Visit 2: Participants will repeat Visit 1 with a different chemical and no artery catheter. - Visit 3: Participants may have a spinal tap. Some fluid will be removed by needle between the bones in the back.

NCT ID: NCT02210221 Completed - Clinical trials for Traumatic Brain Injury

CENTER-TBI: Collaborative European NeuroTrauma Effectiveness Research in TBI

CENTER-TBI
Start date: December 19, 2014
Phase:
Study type: Observational [Patient Registry]

The research aims of the CENTER-TBI study are to: 1. better characterize Traumatic Brain Injury (TBI) as a disease and describe it in a European context, and 2. identify the most effective clinical interventions for managing TBI. Specific aims 1. To collect high quality clinical and epidemiological data with repositories for neuro-imaging, DNA, and serum from patients with TBI. 2. To refine and improve outcome assessment and develop health utility indices for TBI. 3. To develop multidimensional approaches to characterisation and prediction of TBI. 4. To define patient profiles which predict efficacy of specific interventions ("Precision Medicine"). 5. To develop performance indicators for quality assurance and quality improvement in TBI care. 6. To validate the common data elements (CDEs) for broader use in international settings, and to develop a user-friendly web based data entry instrument and case report form builder. 7. To develop an open database compatible with Federal Interagency Traumatic Brain Injury Research (FITBIR). 8. To intensify networking activities and international collaborations in TBI. 9. To disseminate study results and management recommendations for TBI to health care professionals, policy makers and consumers, aiming to improve health care for TBI at individual and population levels. 10. To develop a "knowledge commons" for TBI, integrating CENTER-TBI outputs into systematic reviews.

NCT ID: NCT02207803 Completed - Clinical trials for Traumatic Brain Injury

A Culturally Sensitive Intervention for TBI Caregivers in Latin America

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

Traumatic brain injury (TBI) patients in Latin America experience high levels of disability and extremely poor functional outcomes, and their informal caregivers play a key role in their rehabilitation and care. To improve TBI rehabilitation through stronger informal caregiving, the proposed study will develop and evaluate an evidence--based and culturally sensitive Transition Assistance Program for informal caregivers of patients with TBI in Latin America during the patient's transition from hospital to home. This study will generate findings that can provide empirically supported guidance to clinicians regarding the provision of culturally tailored rehabilitation services for TBI caregivers in Latin America and in the U.S.

NCT ID: NCT02191267 Completed - Clinical trials for Chronic Traumatic Encephalopathy

Tau Imaging of Chronic Traumatic Encephalopathy

Start date: January 2015
Phase: Phase 2
Study type: Interventional

Chronic traumatic encephalopathy (CTE) is a progressive degenerative brain disease with symptoms that include memory loss, problems with impulse control, and depression that can lead to suicide. As the disease progresses, it can lead to dementia. Currently CTE can only be diagnosed postmortem where an over-accumulation of a protein called tau is observed. There is now a new experimental measure that makes it possible, for the first time, to measure tau protein in the living human brain using a novel positron emission tomography (PET) ligand, [F-18] AV-1451 (aka, [18F]-T807). The main objective of this study is to use a novel PET approach to measure tau accumulation in the brain. The presence of CTE at autopsy in deceased National Football League (NFL) players has been well documented. Accordingly, we will conduct this study in a group of retired NFL players who have clinical symptoms of CTE and are suspected of having CTE based on high levels of tau in their spinal fluid and abnormalities seen on research brain scans. We will compare them with a control group of former elite level athletes who have not experienced any brain trauma, deny any clinical symptoms, and who have completely normal spinal fluid tau and amyloid levels, and brain scans. We will also include a group of subjects with AD. All participants will be recruited from ongoing studies, headed by the Partnering PI of this proposal, Dr. Robert Stern, at the Boston University Center for the Study of Traumatic Encephalopathy and the Alzheimer's Disease Center. We will use both a beta amyloid PET scan ([18F]-florbetapir) and a tau PET scan ([18F]-T807) on consecutive days. With the beta amyloid scan we expect little or no evidence of amyloid in the NFL players with presumed CTE, and no evidence of amyloid in the control group of athletes with no history of repetitive brain trauma. In contrast we expect to see beta amyloid accumulation in the AD patient brains. With the new tau ligand, we expect that the NFL players with presumed CTE will show elevated levels of tau protein in the brain, which will not be observed in athletes without a history of brain trauma, but which will be seen in the AD patients' brains. Another goal is to use the latest MRI technologies to develop specific tau imaging biomarkers that correlate with the PET and spinal fluid tau measures but without the radiation of PET or invasiveness of spinal taps. The development of these surrogate imaging markers of tau, is critically important to diagnosing CTE. This in turn will lead to studies relevant to treatment and prevention of this devastating disease. Finally, as an exploratory method of examining possible genetic risk for CTE, we will also use cutting edge genetic analysis of blood samples from subjects in this proposal and compare tau load, measured by PET tau ligand uptake and cerebrospinal fluid (CSF) p-tau level, with a measure of genetic susceptibility to tau load, referred to as the genetic risk score for tau.

NCT ID: NCT02189525 Completed - Clinical trials for Traumatic Brain Injury

Evaluation of Mild TBI in Collegiate Athletes

AWARE
Start date: August 2014
Phase:
Study type: Observational

The purpose of this study is to evaluate blood-based biomarkers before and after sports-induced concussion using neuroimaging and head impact sensor technology.

NCT ID: NCT02161172 Completed - Clinical trials for Mild Traumatic Brain Injury

Cognitive and Psychosocial Outcome After Mild Traumatic Brain Injury

Start date: April 2012
Phase:
Study type: Observational [Patient Registry]

Patients with traumatic brain injury are likely to present with cognitive, psychological, emotional and behavioral problems during different periods, all of which affect patients' life quality seriously. The aim of this study was to assess cognitive and psychosocial outcome in patients with mild traumatic brain injury, and to determine the risk factors associated with cognitive and psychological outcome. Mini-mental state examination (MMSE), activities of daily living scale (ADL), the Hospital Anxiety Depression Scale (HADS) and mental health symptom checklist (SCL-90) were used to assess the cognitive performance and psychological outcomes in 360 patients with mild traumatic brain injury. Chi-square, Fisher's exact tests and Logistic regression analysis were used to analyze the risk factors.

NCT ID: NCT02158494 Completed - Clinical trials for Brain Injuries, Traumatic

Noninvasive Neuromodulation for Treatment of Symptoms Due to Mild or Moderate Traumatic Brain Injury

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

The investigators hypothesis is that electrical stimulation to the tongue that directly stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural impulses to the brainstem and cerebellum. The investigators call this cranial nerve non-invasive neuromodulation (CN-NINM). The activation of these structures induces neuroplasticity when combined with specific physical, cognitive and/or mental exercises, promoting recovery of selected functional damage such as problems with balance or walking. 44 subjects will be recruited for 2 weeks of intensive In-Lab Balance and Gait Training followed by 12 weeks of intensive Home Training with weekly In-Lab check sessions. Half of the subjects will use CN-NINM in conjunction with the exercise. Half of the subjects will use very low level stimulation in conjunction with the exercise, and will serve as a control group.

NCT ID: NCT02152540 Completed - Clinical trials for Traumatic Brain Injury

rTMS to Improve Cognitive Function in TBI

rTMSTBI
Start date: October 1, 2014
Phase: N/A
Study type: Interventional

This project will study 40 Veterans identified with symptoms understood to characterize mild to moderate Traumatic Brain Injury (TBI) including Post Traumatic Stress Disorder (PTSD). Following screening and informed consent, Veterans will be randomly assigned to treatment with repetitive Transcranial Magnetic Stimulation (rTMS) or sham rTMS (placebo). Additional examinations will compare brain imaging (structural and functional MRI scans at rest) across participants at baseline, after acute rTMS treatment, and at 6 month followup. The VA population differs significantly from populations that have been included in prior trials of rTMS for many conditions such as depression, chronic pain, and PTSD. Many returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) personnel and Veterans with concussion histories report cognitive problems, such as impaired attention, verbal fluency, poor planning, reduced working memory, and mental flexibility. The investigators hope to show the efficacy and durability of rTMS in treating these symptoms safely in Veterans with co-morbidities.