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Brain Injuries, Traumatic clinical trials

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NCT ID: NCT01502436 Completed - Clinical trials for Traumatic Brain Injury

An Exploration of the Relationship Between Chronic Pain and Suicide Attempt Among Veterans

Start date: June 2008
Phase:
Study type: Observational

The purpose of this study is to explore the relationship between attempted and/or completed suicide and reported experience of chronic pain among an adult veteran population. Specific aims include a) examining the experience of chronic pain between patients who have either attempted and/or completed suicide, non-suicide attempt mental health patients, and non-mental health chronic pain patients and b) determining possible differences in reported experiences of chronic pain based on mental and physical diagnoses, age, gender, ethnicity, occupation, and patient's recorded perceptions of depression and/or quality of life. As articulated in the Amendment approved on June 13, 2008, additional areas of interest include histories of neurological disease (e.g. traumatic brain injury) and/or mental health diagnoses. History of both neurologic disease and mental health diagnoses will also be identified by chart review (per approval obtained June 13, 2008). As such this study will also compare differences (e.g., mental health, neurological disease) between veterans who have history of a suicide attempt, completion, or a lifetime history of suicidality and matched control veterans without a history of suicide attempts, completions, or lifetime history of suicide. The relationship between suicidal behavior, attempted/completed suicide, and reported Post Traumatic Stress Disorder (PTSD) symptoms among an adult veteran population is also of interest. Additionally, this data set will be used to complete a validation study regarding the Self-Directed Violence Classification System (SDVCS). Specifically, relevant information in subject chart notes regarding self-directed violence (SDV) will be used to categorize thoughts and behaviors according to the SDVCS.

NCT ID: NCT01496586 Completed - Clinical trials for Traumatic Brain Injury

Service Member Fatigue and Lack of Motivation Following Concussion

Start date: December 1, 2011
Phase:
Study type: Observational

Background: - Many service members have reported feeling tired, a loss of motivation, mood changes, and problems working with others after they have a concussion during deployment. These problems may lead to problems with their job and relationships. This study hopes to figure out what parts of the brain may be affected in people with these problems after a concussion. Objectives: - To learn more about the problems that may occur after service members have a concussion during deployment and return home. Eligibility: - Service members or veterans between 18 and 40 years of age who have had a mild traumatic brain injury (concussion) in the past 6 months. - Companions (at least 18 years of age) of the service members will also be included in this study. Companions will have interacted with the service member at least 1 hour a week since deployment. Design: - Service members will have 1 week of tests at the National Institutes of Health Clinical Center. Companions will have 2 days of tests at the Center. - Each day, service members will have 4 or 8 hours of tests. Tests will include a medical history and physical exam, neuropsychological tests and imaging studies. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support. The imaging studies will measure brain function at rest and during activity. - Companions will have a medical history and physical exam. They will also complete several questionnaires about themselves as well as the service member/veteran. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support....

NCT ID: NCT01454154 Completed - Clinical trials for Traumatic Brain Injury

Glyburide (RP-1127) for Traumatic Brain Injury (TBI)

Start date: December 17, 2011
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to assess whether participants with traumatic brain injury (TBI) administered glyburide begun within 10 hours of injury will show a decrease in magnetic resonance imaging (MRI)-defined edema and/or hemorrhage, compared to placebo and to assess the safety and tolerability of glyburide compared to placebo in participants with TBI. The secondary objectives include analyzing brain cell loss, computerized tomography (CT) scan /MRI abnormalities, reduction of mortality and or improvement of function or physiology, incidence of decompression craniectomy, incidence of neuroworsening, and to assess the steady state concentrations of glyburide in TBI participants.

NCT ID: NCT01427959 Completed - Clinical trials for Traumatic Brain Injury

Tampere Traumatic Head and Brain Injury Study

TheBrainS
Start date: November 2010
Phase:
Study type: Observational

Tampere Traumatic head and brain injury study is a prospective study aiming to explore neuroradiological, neuropsychological, neurological and biochemical aspects of mild traumatic brain injury (mtbi). The main interest is on factors that effect to the outcome after mtbi. The study is conducted in Tampere University Hospital's emergency department between the 1st of August 2010 and 31st of July 2013.

NCT ID: NCT01426919 Completed - Clinical trials for Traumatic Brain Injury

Evaluation of Biomarkers of Traumatic Brain Injury

ALERT-TBI
Start date: December 2012
Phase:
Study type: Observational

The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma Scale score 9-15) in conjunction with other clinical information within 12 hours of injury to assist in determining the need for a CT scan of the head.

NCT ID: NCT01420042 Completed - Clinical trials for Brain Injuries, Traumatic

Safety Study of NNZ-2566 in Healthy Subjects, Following Oral Administration

Start date: February 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to obtain evidence of safety and determine the pharmacokinetics (PK) of NNZ-2566 in healthy volunteers, when administered orally.

NCT ID: NCT01419223 Completed - Clinical trials for Post-Traumatic Stress Disorder

Patient Participation Beliefs and Post-Traumatic Stress Disorder (PTSD)

Start date: July 2011
Phase: N/A
Study type: Observational

This is an exploratory qualitative interview study being conducted with a primary objective of examining perceptions held by active military and veterans regarding help-seeking attitudes and mental health beliefs which influence the decision to consent or decline participation in Post-Traumatic Stress Disorder (PTSD) or Traumatic Brain Injury (TBI) clinical trials. Active duty military and/or veterans aged 18 years and older who consent to participate (N = 50), or have recently declined participation (N = 50), in an INTRuST affiliated outpatient clinical trial for deployment-related PTSD or TBI will be recruited. Participants who consent to participate in an INTRuST clinical trial (Group 1) will be interviewed once at the beginning the of the clinical trial, and again following participation in the trial. Participants who decline participation in an INTRuST affiliated outpatient clinical trial (Group 2) will be interviewed once. For participants in both groups, study participation will initiate within 1 month of referral to study. Total duration of study participation is based on the specific clinical trial that the participant is recruitment from; the longest trial is estimated to be 24 weeks or less. Semi-structured qualitative individual interviews will be conducted to carry out a thematic analysis of the data exploring familial, social and institution-level constructs which may influence the subjective experience of the research treatment process.

NCT ID: NCT01418976 Completed - Clinical trials for Brain Injuries, Traumatic

Walking and Balance Post-TBI

Start date: July 2011
Phase: N/A
Study type: Interventional

This is a case series study evaluating the feasibility and dosage of Intensive Mobility Training (IMT). Twelve participants with chronic, mild-to-moderate, Traumatic Brain Injury (TBI) causing significant locomotor impairment, who meet these specific criteria, will be recruited. Location and nature of neural insult will be determined by multimodal Magnetic Resonance Imaging (MRI) exam. All participants will receive 3 hours of rehabilitation per day for 20 days, focusing on gait and balance. Locomotion and balance will be comprehensively tested prior to IMT, after 10 days of IMT, and then again after the full dose of IMT. This study will determine the feasibility of this intervention in the population of TBI patients, allow an estimate of effect size and provide initial information on possible neural predictors of success. Furthermore the investigators will be able to determine whether the dosage of 10 days is sufficient or whether significant improvements are made with 20 days of the intervention.

NCT ID: NCT01418820 Completed - Stroke Clinical Trials

Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions

Start date: March 2011
Phase: Phase 2
Study type: Interventional

Visual field areas, which are not absolutely blind, are hypothesized to have some residual capacities that constitute their potential for vision restoration. Vision restoration can be achieved by varies methods including behavioral training and electrical brain stimulation such as transcranial direct current stimulation (tDCS) and repetitive transorbital alternating current stimulation (rtACS) which are able to influence the excitability and activity of cortical areas. It is hypothesized that transorbital alternating current stimulation (tACS) can improve the residual field of vision in patients with post-chiasmatic lesions.

NCT ID: NCT01410721 Completed - Clinical trials for Traumatic Brain Injury

Neural Markers and Rehabilitation of Executive Functioning in Veterans With Traumatic Brain Injury and Posttraumatic Stress Disorder

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

Up to half of all military service members with combat-related traumatic brain injury (TBI) also suffer from Posttraumatic Stress Disorder (PTSD). TBI and PTSD are each associated with cognitive problems in what are called 'executive functions' such as planning actions, inhibiting behavior, monitoring one's own thoughts and feelings, and solving problems day-to-day. These types of impairments occur more often among veterans with both TBI and PTSD than among those with only one of these conditions. The combination of TBI and PTSD in veterans has also been linked to problems with anger and violence, which are common complaints of veterans seeking mental health services post-deployment and have been shown to predict poor treatment outcomes in Iraq and Afghanistan veterans. Although the relationship between combined TBI/PTSD diagnoses and post-deployment adjustment problems has been demonstrated, there has been little research into clinical interventions designed to reduce the severity of cognitive and affective symptoms in veterans with both TBI and PTSD. Therefore, the investigators propose a randomized clinical trial involving a cognitive rehabilitation intervention that targets improved executive functioning, with the participation of N=100 veterans diagnosed with both TBI and PTSD (n=50 in experimental group and n=50 comparison). As part of the study, all participants will receive an iPod touch. Participants will be placed into one of the two study groups randomly. Based on which group participants are placed in, they will receive one of two different sets of iPod touch apps and programs that address and aim to improve different facets of cognitive functioning. Regardless of which group, Veterans will be instructed to daily practice iPod touch applications on cognitive functioning. Also, family members will be trained as "mentors" to reinforce use of the applications in everyday living environments. Trained facilitators will also travel to participants' homes to meet with veterans and family to observe behaviors in the home environment, arrive at strategies for applying new skills in their situations, troubleshoot any iPod technical problems, and review family mentoring processes. The investigators will measure clinical outcomes using a comprehensive array of functional and structural methods at baseline and six months. The investigators hypothesize improved executive function among those in the experimental group as well as reduced irritability/impulsivity and improved social/occupational functioning. The investigators further hypothesize that, as a group, veterans participating in the cognitive rehabilitation program will show significant changes in neural activity associated with executive functions when comparing pre- and post-treatment EEG and fMRI responses. Better understanding of the neural circuitry and neurocognitive function underlying executive function and associated affective control deficits in veterans with both TBI and PTSD, and how they relate to treatment outcome, will allow us to better identify therapeutic targets for cognitive rehabilitation. The current proposal aims to explore the relationship between brain function and connectivity in selective pathways/circuits, neuropsychological functioning, and cognitive rehabilitation response in veterans with both TBI and PTSD. This study of the neurobiology and neuropsychology associated with intervention efficacy will allow us to identify veterans with both TBI and PTSD who are predisposed to positive treatment outcomes. To our knowledge, this will be the first attempt to integrate neurobiological and neurocognitive techniques with information about the efficacy of a theoretically and empirically driven cognitive rehabilitation intervention in veterans with combined TBI/PTSD diagnoses. This research may suggest additional avenues for assessment of clinical intervention efficacy and the identification of therapeutic targets (e.g. alteration of function in fronto-limbic circuits) relevant to the military population. Given links between TBI/PTSD, executive dysfunction, and anger, impulsivity, and aggression, efforts to rehabilitate cognitive function will be particularly important to ensure that current and future veterans adjust successfully when they return home to their families, workplaces, and communities.