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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT02424656 Completed - Clinical trials for Traumatic Brain Injury

Alterations in the Brain's Connectome After Severe Traumatic Brain Injury

ABCinTBI
Start date: September 2014
Phase:
Study type: Observational

This study explores the changes in whole-brain connectivity that occur during recovery from severe Traumatic Brain Injury and how these changes are related to the recovery of consciousness. Multimodal neuroimaging techniques will be used in a longitudinal fashion while patients are undergoing neurorehabilitation and after one-year of the TBI episode.

NCT ID: NCT02420639 Completed - Clinical trials for Traumatic Brain Injury

Prospective, Interventional Study Evaluating the Feasibility and Safety of the Esophageal Cooling Device

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

The aim of this prospective, interventional study is to assess the feasibility and safety of the Esophageal Cooling Device in patients from suffering from traumatic brain injury who the treating physician is treating with targeted temperature management. Comparison of outcomes will be made to historical controls. The primary outcome is the feasibility of inducing, maintaining, and rewarming patients from targeted temperature management using the Esophageal Cooling Device (cooling rate, rewarming rate, and the percent of time within goal temperature during the goal-temperature maintenance period). Evaluation of adverse events (including cardiac arrhythmias, severe bradycardia, myocardial infarction/re-infarction, dysphagia, odynophagia, aspiration pneumonia, non-aspiration pneumonia, reflux, esophageal injury, and esophagitis) will be closely monitored during the whole period of targeted temperature management (secondary endpoint).

NCT ID: NCT02416492 Completed - Clinical trials for Traumatic Brain Injury

A Study of Modified Stem Cells in Traumatic Brain Injury (TBI)

STEMTRA
Start date: July 6, 2016
Phase: Phase 2
Study type: Interventional

The primary purpose of the clinical study is to evaluate the clinical efficacy of intracranial administration of SB623 cells on patients with chronic motor deficit from Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of intracranial administration of SB623 cells on disability parameters and 2) to evaluate the safety and tolerability of intracranial administration of SB623 cells. Patients with stable, chronic motor deficits secondary to focal traumatic brain injury must be 12 months post TBI.

NCT ID: NCT02411227 Completed - Clinical trials for Traumatic Brain Injury

Neurocognitive Driving Rehabilitation in Virtual Environments (NeuroDRIVE) as an Adjunctive Intervention for Traumatic Brain Injury

Start date: April 7, 2015
Phase: Phase 2
Study type: Interventional

Background: - People with traumatic brain injury (TBI) can have problems with thinking and everyday activities. They may have a higher risk for car accidents. NeuroDRIVE uses a virtual reality driving simulator. Researchers think it can help test and improve how people think and drive after TBI. Objective: - To test how NeuroDRIVE affects brain performance and driving safety. Eligibility: - People at least 18 years old with a history of TBI and who had a driver s license at some point. They must speak, read, and write English and be physically able to drive. Design: - Participants will be asked to release their driving records, but they do not have to do this to be in the study. - Visit 1: Screening physical exam. - Visit 2: Magnetic resonance imaging (MRI) scan. Participants will lie on a table that slides into a cylinder with a strong magnetic field. A device will be placed over the head. Participants may do computer tasks during the scan. - Participants will have tests of memory, attention, and thinking. They may be asked questions, take tests, and do simple actions. - Visit 3: Tests of memory, attention, and thinking, plus a virtual reality driving assessment. - Participants will be assigned to Group 1 to start NeuroDRIVE training immediately or Group 2 to start 10 weeks later. - Visits 4 9, over 4 weeks: - Participants will practice driving skills and mental exercises in the simulator. - They will complete a driving questionnaire online each week. - Visit 10: Repeat of Visit 3, with some small changes. - Visits 11-12: Very similar to Visits 1-2. Includes MRI scan; physical exam; questionnaires; and tests of thinking, memory, and attention.. - After Visit 12: Participants will fill out a weekly driving survey online for 4 weeks.

NCT ID: NCT02398409 Completed - Stroke Clinical Trials

Informal Caregivers ANSWERS-VA

Start date: November 3, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effectiveness of the ANSWERS- VA intervention (Acquiring New Skills While Enhancing Remaining Strengths for Veterans) while also determining it's cost effectiveness in the stroke and traumatic brain injury (TBI) populations.

NCT ID: NCT02392975 Completed - Clinical trials for TBI (Traumatic Brain Injury)

Fast MR for Young Children With Traumatic Brain Injury

Start date: June 2, 2015
Phase: N/A
Study type: Interventional

This proposal will test the diagnostic utility of fast magnetic resonance (MR) in young children with Traumatic brain Injury (TBI). In children, TBI causes >2000 deaths, 35,000 hospitalizations and 470,000 emergency department visits in the US each year, making it a leading cause of pediatric disability and death. Currently 20-50% of these children undergo computed tomography (CT) scanning, exposing them to harmful radiation, and increasing their lifetime risk of cancer. Risks are especially increased in children because the neurologic exam is less reliable, because growing tissues are more vulnerable to radiation, and because children have more years to accumulate harmful mutations. Fast MR is a short, motion-tolerant protocol that has been used in children with shunted hydrocephalus to eliminate radiation exposure without the need for sedation. However, fast MR has not been validated in children with TBI, a critical gap. The investigators will measure feasibility and diagnostic utility of fast MR in children < 6 years (72 months) old who undergo head CT for TBI. The Investigator will recruit children in whom a head CT is ordered for TBI. Consenting subjects will undergo fast MR shortly after CT and results will be compared to determine: 1) whether fast MR identifies all traumatic injuries identified by CT and 2) whether fast MR without sedation can be performed quickly and successfully.

NCT ID: NCT02383472 Completed - Brain Concussion Clinical Trials

LED Therapy for the Treatment of Concussive Brain Injury

Start date: September 2012
Phase: N/A
Study type: Interventional

A double blind randomized trial of light-emitting diode (LED) therapy for patients suffering from mild traumatic brain injury (mTBI). Patients seen in the Sports Concussion Clinic with cognitive symptoms lasting for greater than 4 weeks will be randomized to either placebo therapy (controls) or treatment with LED therapy (cases). Both cases and controls would complete post-concussion symptom scales Delis-Kaplan Executive Function System (D-KEFS), and ImPACT studies on entry into the study and at weeks 3 and 6, or earlier if their symptoms resolve before the end of the 6 week period.

NCT ID: NCT02374918 Completed - Concussion, Mild Clinical Trials

Bright Light Therapy for Treatment of Sleep Problems Following Mild Traumatic Brain Injury

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

The purpose of the research study is to understand the effectiveness of a six-week course of light exposure on cognitive functioning, mood, activity, and sleep in people that have suffered a head injury leading to a concussion.

NCT ID: NCT02367521 Completed - TBI Depression Clinical Trials

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)

rTMS TBI
Start date: March 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Traumatic brain injury (TBI) is frequently complicated by depression and other problems such as post traumatic stress disorder (PTSD), sleep disturbance, cognitive deficits and behavioral problems. Untreated depression can lead to reduced productivity and poor global outcome. There is no Food and Drug Administration (FDA) approved drug for the treatment of TBI-related depression. The overarching goal of this small study is to determine the effectiveness of low frequency right (LFR) rTMS for the treatment of post-TBI depression and co-occurring psychiatric symptoms. Repetitive transcranial magnetic stimulation (rTMS) is a brain stimulation technique. It involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. Adults aged 18 and older, with a history of head injury of mild or moderate severity , who are currently experiencing symptoms of clinical depression may join the study.

NCT ID: NCT02352441 Completed - Clinical trials for Traumatic Brain Injury

Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction

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

Many Service members (SM) experience executive dysfunction associated with mild traumatic brain injury symptom complex (mTBI-sc), for which they receive cognitive rehabilitation. Cognitive rehabilitation (CR) for executive dysfunction often involves metacognitive strategy instruction (MSI) to help patients self-regulate their behavior though a goal management process - identifying a goal, anticipating performance problems, generating possible solutions, self-monitoring performance during the activity, recognizing maladaptive task strategies, stopping and then modifying real-time task behavior by choosing an alternate strategy. MSI alone often does not result in improved daily functioning because it requires conscious cognitive oversight to employ (which is difficult for people with executive dysfunction) and it presumes that simply establishing goals propels goal-directed action, when for many people, this is not so. Social psychologists report that people who set implementation intentions (if-then statements that link specific situational cues with specific goal actions) are more likely to perform goal actions than those who only set goal intentions. Implementation intentions are believed to be effective because they enable people to switch from conscious-effortful reflective action control to automatic, reflexive action control associated with selected situational cues. A team of researchers from the Courage Kenny Research Center (CKRC), Traumatic Brain Injury Center at Fort Campbell, KY (TBIC-FC), and Neurofunctional Research and Consulting has developed a brief CR intervention to teach SM with mTBI-sc to set implementation intentions called ACTION (AutomatiC iniTiation of IntentiONs) sequence training. The purpose of this pilot study to evaluate: 1) the practicality of instructional methods used to teach SM with mTBI-sc to perform the ACTION sequence and 2) the efficacy of ACTION sequence training in achieving personal goals and performance on a task that challenges executive function using a small randomized controlled trial. If the results are positive, a larger study would be conducted to determine the impact of ACTION sequence training on SM performance on military-relevant tasks and goals.