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Brain Injuries clinical trials

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NCT ID: NCT01205607 Enrolling by invitation - Clinical trials for Traumatic Brain Injury

IRB-HSR# 14299: The Use of the Intrathoracic Pressure Regulator (ITPR) to Improve Cerebral Perfusion Pressure in Patients With Altered Intracranial Elastance

Start date: May 2009
Phase: Phase 2
Study type: Interventional

Patients who have a functioning intracranial pressure-monitoring device (either a subarachnoid bolt, or an intraventricular catheter) in place, and are either sedated, intubated, and mechanically ventilated (i.e. in the NNICU), or are scheduled to undergo an operation or interventional neuroradiological procedure at the University of Virginia. Patients with a contraindication to TTE will be excluded. For patients in the NNICU, basic hemodynamic variables (systemic blood pressure, central venous pressure, etc.) will be collected. In addition, left ventricular performance (including estimates of LVEDV, LVESV, EF, FAC, and SV) will be assessed using TTE. Once these baseline data are recorded, the ITPR will be inserted in the ventilator circuit and activated to provide either -5 mm Hg or -9 mm Hg endotracheal rube pressure (ETP) (based on a randomization scheme). After the ITPR has been active for at least five minutes, the same intracranial, hemodynamic, and TTE data obtained above will be gathered. The ITPR will then be turned off for five minutes, and intracranial, hemodynamic, and TTE data will again be recorded. The ITPR will be activated a second time (-9 mm Hg or -5 mm Hg ETP, i.e. whichever value was not used previously), and after five minutes of use data will be recorded again. The ITPR will then be disconnected, data will be collected after waiting two minutes, and no further interventions will be made. ABG's will be obtained before and during the use of the device at each setting. This is a proof of concept/feasibility study designed to test the primary hypothesis that use of the ITPR will result in decreased intracranial pressure and increased cerebral perfusion pressure. The effect of the ITPR on secondary indicators of cardiac performance will also be examined. These include but are not limited estimates of ventricular end diastolic volume and pressure (LVEDV/P), ejection fraction (EF), left ventricular end systolic volume and pressure (LVESV/P), fractional area change (FAC), all of which will be assessed by transthoracic echocardiography (TTE) or transesophageal echocardiography (TEE).

NCT ID: NCT01202110 Terminated - Clinical trials for Traumatic Brain Injury

Early Propranolol After Traumatic Brain Injury: Phase II

EPAT: Phase II
Start date: June 2010
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to determine in patients with traumatic brain injury (TBI) the safe dosing of propranolol. Safety will be measured by episodes of bradycardia (heart rate < 60 beats per minute), hypotension (defined as systolic blood pressure < 90) or decreased cerebral perfusion pressure (defined as CPP less than 60mmHg) that are refractive to Brain Trauma Foundation guidelines for treatment. A no-treatment arm will establish the number of episodes of bradycardia, hypotension and reduced cerebral pressure refractory to treatment that occur without propranolol.

NCT ID: NCT01201863 Completed - Trauma Clinical Trials

Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy

Start date: September 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study was to address 3 short term objectives; (1) Determine the effects of physiologic testosterone (T) therapy on neurological function and functional independence following traumatic brain injury (TBI) in hypogonadal men during inpatient rehabilitation; (2) Document the natural history of neuroendocrine dysfunction and recovery in men during inpatient rehabilitation after TBI; (3) Obtain data to validate the NIH toolbox, a novel assessment of neurological function for use in the TBI population; and 2 long-term objectives: (1) Utilize study findings to design a multicenter trial to further assess the impact of T therapy in hypogonadal men following TBI and (2) Impact TBI practice management with new information about neuroendocrine dysfunction after TBI and hormone treatments to improve outcomes.

NCT ID: NCT01201291 Terminated - Clinical trials for Traumatic Brain Injury | Patient

Impact of Inspired Oxygen Fraction on Outcome in Patients With Traumatic Brain Injury

BRAINOXY
Start date: November 2010
Phase: N/A
Study type: Interventional

Aim of the study is to investigate the impact of two different fractions of inspired oxygen (FiO2) on outcome in patients with severe traumatic brain injury (TBI).

NCT ID: NCT01198964 Recruiting - Epilepsy Clinical Trials

Optimization of Human Cortical Stimulation

BCI
Start date: September 2010
Phase:
Study type: Observational

We will observe epileptic patients who already have electrodes implanted on the brain and are receiving high-level brain stimulation for clinical purposes while testing their motor and language function. We propose to do a limited, low-level brain stimulation to show that the signatures of local activity in the target area change as an effect of brain stimulation. The goal of this study is to understand the feasibility of a novel recurrent brain-computer interface that could eventually promote targeted functional recovery in subjects who have had a brain injury.

NCT ID: NCT01196299 Completed - Clinical trials for Traumatic Brain Injury

Imaging of Traumatic Brain Injury

Imaging of TBI
Start date: March 21, 2010
Phase:
Study type: Observational

This project aims to study the prognostic ability of various MRI imaging markers in the evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison to the TBI patients. It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional connectivity, and tissue microstructure will be related to the clinical status of the patient, as well as their social and occupational outcomes.

NCT ID: NCT01194661 Completed - Stroke Clinical Trials

Neural Dynamics and Connectivity in Response Inhibition and Traumatic Brain Injury

Start date: August 10, 2010
Phase:
Study type: Observational

Background: - Previous research has shown that certain parts of the brain are involved in voluntarily stopping an ongoing motor response (movement); however, it is not known whether this same network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can significantly impair the brain's ability to voluntarily stop or inhibit certain actions. Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation (transcranial magnetic stimulation, or TMS) to investigate how people perform activities that involve moving and suppressing movements, researchers hope to better understand how these brain areas might be affected in people who have had TBI. Objectives: - To determine the parts of the brain involved in suppressing an urge to act. - To determine the extent to which traumatic brain injury affecting certain parts of the brain is involved in problems with suppressing an urge to move and stopping movement. Eligibility: - Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy volunteers. Design: - This research study includes a screening visit and two study visits, each of which will last at least 2 hours. - Participants will be screened with a physical examination and medical history. Women who can become pregnant will have a urine pregnancy test before being allowed to participate in the study. - At the first study visit, participants will complete one of the following experiment tests in an MRI scanner. - Experiment 1: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will practice the experiment tasks before performing them during MRI scans. - Experiment 2: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will also have TMS while at rest, and will perform the experiment tasks during the MRI scan. - At the second study visit, participants will have an fMRI scan where they will be asked to do simple response tasks with a computer outside the MRI scanner. Background: - Previous research has shown that certain parts of the brain are involved in voluntarily stopping an ongoing motor response (movement); however, it is not known whether this same network is also involved in suppressing an urge to act. Traumatic brain injury (TBI) can significantly impair the brain's ability to voluntarily stop or inhibit certain actions. Using brain imaging (functional magnetic resonance imaging, or fMRI) and brain stimulation (transcranial magnetic stimulation, or TMS) to investigate how people perform activities that involve moving and suppressing movements, researchers hope to better understand how these brain areas might be affected in people who have had TBI. Objectives: - To determine the parts of the brain involved in suppressing an urge to act. - To determine the extent to which traumatic brain injury affecting certain parts of the brain is involved in problems with suppressing an urge to move and stopping movement. Eligibility: - Individuals 18 to 40 years of age who have had mild or moderate TBI, or are healthy volunteers. Design: - This research study includes a screening visit and two study visits, each of which will last at least 2 hours. - Participants will be screened with a physical examination and medical history. Women who can become pregnant will have a urine pregnancy test before being allowed to participate in the study. - At the first study visit, participants will complete one of the following experiment tests in an MRI scanner. - Experiment 1: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will practice the experiment tasks before performing them during MRI scans. - Experiment 2: Participants will be shown arrows or images on a computer screen, and will press a button or not press a button depending on the image shown. Participants will also have TMS while at rest, and will perform the experiment tasks during the MRI scan. - At the second study visit, participants will have an fMRI scan where they will be asked to do simple response tasks with a computer outside the MRI scanner.

NCT ID: NCT01175993 Completed - Clinical trials for Traumatic Brain Injury

Effects of Rapid-Resisted Exercise and Bright Light Therapy on Ambulatory Adults With Traumatic Brain Injury

Start date: August 24, 2011
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Traumatic brain injury may have a range of effects, from severe and permanent disability to more subtle functional and cognitive deficits that often go undetected during initial treatment. To improve treatments and therapies and to provide a uniform quality of care, more research is needed into different treatments for traumatic brain injury. - Exercise has been shown to improve movement and balance in people with strokes, cerebral palsy, and other conditions that affect the brain, and can improve symptoms of memory problems or depression. Bright light therapy has also been shown to improve mood in people with depression. Researchers are interested in studying problems with movement, balance, thinking, and mood in people with traumatic brain injury. By comparing the effects of exercise and bright light exposure on brain function, new treatments may be developed for acute traumatic brain injury. Objectives: - To compare the effects of exercise and bright light therapy on the brain function of individuals with traumatic brain injury. Eligibility: - Individuals between 18 and 44 years of age who either have been diagnosed with traumatic brain injury or are healthy volunteers. Design: - Individuals with traumatic brain injury will have four outpatient evaluation visits at the clinical center, a 3-month home exercise program, and a 3-month bright light exposure program at home. Healthy volunteers will have one evaluation visit at the clinical center. - At the first study visit, all participants will have a full physical examination and medical history. Individuals with traumatic brain injury will also have an eye exam to determine if it is safe for them to receive light therapy. - All participants will have the following initial tests: - Tests of walking and movement, including monitoring by a physical therapist; tests to record joint movement and evaluate muscle function; tests that combine movement, thinking, and speaking; and balance and reaction time tests. - Magnetic resonance imaging scans - Tests of thinking and mood, including questionnaires, computerized tests, and simple action tests. - Participants with traumatic brain injury will have separate 3-month sessions of exercise and bright light therapy, with additional evaluation visits between each 3-month session and at the end of the study. Between the 3-month sessions, participants will have 1 month with no intervention. - Exercise sessions will involve regular workouts on an elliptical machine for 30 minutes for 5 days a week, and bright light therapy sessions will involve sitting in front of a light box for 30 minutes for 5 days a week. Participants will keep a journal to monitor the effects of the therapy.

NCT ID: NCT01171131 Completed - Clinical trials for Traumatic Brain Injury

A Pilot Study to Identify Biomarkers Associated With Chronic Traumatic Brain Injury

Chronic TBI
Start date: April 2010
Phase:
Study type: Observational

The aim of this research is to determine if the biological fluids (blood/saliva) from chronic brain-injured patients (both blast and non-penetrating TBI) contain reproducible protein markers. To accomplish this two populations of chronic TBI patients who are receiving treatment at The Institute for Research and Rehabilitation (TIRR): blast injury victims and non-penetrating TBI will be studied. Using multiple proteomic approaches including mass spectrometry, multiplex ELISAs, and antibody microarrays, as well as RNA profiling, the investigators aim to identify biomarkers in the blood/saliva of patients suffering from chronic TBI and to determine the similarities/differences between the blast and non-penetrating injury groups. Identification of these biochemical changes will give insight into the long-lasting changes associated with head injury, and may identify new targets for treating the associated pathologies.

NCT ID: NCT01166386 Completed - Clinical trials for Traumatic Brain Injury

Acute Neurobehavioral Program for Improving Functional Status After TBI

Start date: March 2008
Phase: N/A
Study type: Interventional

The specific aims of the proposed study are to 1) evaluate the efficacy of FANCI for improving functional status following treatment using the FIM, 2) examine the impact of FANCI on broader outcome measures of general emotional and behavioral functioning and productive activity in the community as measured post-treatment and at 6-month follow-up, 3) examine contributions of participant injury severity and cognitive status at time of treatment to treatment outcome and treatment response, 4) examine contributions of treatment variables of session topic and mastery, caregiver presence, and concurrent therapies on treatment outcome and treatment response for inpatients with TBI. Primary outcome measure is the (FIM). We will secondarily compare scores on the Disability Rating Scale (DRS), Glasgow Outcome Scale-Extended (GOSE), Rehabilitation Intensity of Therapy Scale (RITS), and Frontal Systems Behavior Scale (FRsBe). Our design is a parallel groups, single-blind, randomized, controlled trial. We will enroll 150 (75 treatment, 75 control) participants. Inclusion Criteria: Mod to Sev TBI based on time to commands, English speaker, Length of stay ≥ 5 days in acute BI rehabilitation Unit, 18 years of age or older, ≥ 79 on GOAT.