Active clinical trials for "Brain Injuries"

The investigators propose to conduct a 2-arm, open-label pilot study to determine if early treatment with amitriptyline will decrease the frequency and severity of headaches after mild traumatic brain injury (TBI). Amitriptyline is a tricyclic antidepressant that is commonly available and inexpensive. It is used as a first-line drug for primary headache prevention in a very low dose range of 10-50 mg. Specific Aim 1 is to conduct a 2-arm open-label study to examine the effect of preventive treatment with amitriptyline on the frequency and severity of headache after mild TBI. Specific Aim 2 is to collect data needed for design of a Phase 3 study, including an estimate of effect size, headache variability, and desirable drug treatment start date. Specific Aim 3 is to examine the feasibility of using headache diaries with individuals with mild TBI. Specific Aim 4 is to establish the safety and tolerability of amitriptyline for the prevention of headache after mild TBI. The investigators hypothesize that early preventive treatment with amitriptyline will avert the development of chronic post-traumatic headache (PTH) as compared to rates of headache from a recent natural history study on PTH after mild TBI. The investigators propose to enroll inpatient subjects from a Level I trauma center as well as from outpatient clinics and from the general community with a diagnosis of mild TBI. Subjects will be screened for current headache. After baseline assessment, 72 subjects with current headache will be randomized to one of 2 groups. Group 1 will immediately begin amitriptyline and or Group 2 will be followed and begin amitriptyline at Day 30. All subjects will be asked to complete a daily headache diary beginning on Day 1 of the study. A detailed medical history and headache survey will be completed. Subjects will have a scheduled stepped increase in the drug dosage every week for 3 weeks to the maximum study dosage of 50 mg. Weekly telephone calls will monitor for adverse events and compliance with the drug and headache diary. Clinic visits will occur at 30, 60 and 90 days. The 30 day clinic visit will include cognitive testing to assess for differences between groups and initiation of drug treatment for Group 2. Both 30 and 60 day visits will include review of headache diary, potential adverse effects, and pill counts. The 90 day visit will be for outcome assessment. In addition, the headache survey will be repeated by telephone at Day 180.

Traumatic Brain Injury (TBI) - methylphenidate treatment

This project addresses the rehabilitation and mental health needs of married combat Veterans post-deployed from Iraq or Afghanistan with a mild traumatic brain injury (mTBI) and/or significant posttraumatic stress (PTS) or combat-related stress (CS) by providing psychoeducation, communication and problem solving skills in a multifamily group (MFG) setting. In this group, Veterans and spouses/cohabiting partners learn customized therapeutic strategies to help compensate for deficits and promote Veteran community integration, interpersonal and emotion regulation skills, and marital satisfaction. The effectiveness of the skills-based MFG will be compared to that of a health education group which offers a supportive environment and basic education without skills training through a randomized clinical trial. As there is currently no family-based intervention for Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans with mTBI offered within the VA spectrum of services, this intervention fills a crucial gap in healthcare for our newest Veterans.

The majority of trauma survivors experience prolonged and profound physical and psychosocial disability, with up to 50% unable to return to productive employment. The Centers for Disease Control (CDC) estimates that more than 1 million of these individuals experience a mild traumatic brain injury (TBI) and cost the United States nearly $17 billion each year. Symptoms related to mild TBI result in cognitive, functional, and emotional impairments that can lead to vocational and social disability. Long-term cognitive deficits include problems with memory and attention, and most importantly executive functioning. Depressive and post-traumatic stress disorder (PTSD) symptoms are extremely common in individuals with cognitive impairment, occurring in up to 50% and 33% of individuals, respectively. The investigators have found that 55% of trauma patients with mild TBI have profound cognitive impairments in executive functioning at one-year survival. Executive functioning is defined as "a cognitive domain that controls the execution of complex activities of daily living essential for purposeful, goal directed behaviors." Deficits in executive functioning are the most disabling of all cognitive impairments and affect a person's ability to manage effectively in one's personal and professional life. Current literature shows that deficits in executive functioning contribute to reduced quality of life, difficulty in returning to work, and persistent psychological distress in various medical and surgical populations. Cognitive rehabilitation has proven effective for decreasing persistent cognitive impairment and functional disability in patients with TBI. The overall goal of cognitive rehabilitation is not only to improve a person's ability to process and interpret information but to increase self-confidence and self-efficacy for coping with emotional distress. Despite evidence supporting the use of cognitive rehabilitation, few studies have systematically addressed cognitive treatment for individuals with mild TBI. Therefore, the investigators propose to conduct a three-group randomized controlled trial to determine the efficacy of Goal Management Training (GMT), a structured manual-based intervention targeting executive functions that impact a person's ability to carry out daily tasks. The investigators hypothesize that telephone-based GMT will improve cognitive functioning, functional status, and psychological health in trauma survivors with mild TBI. Emerging research suggests that telephone rehabilitation is a feasible and effective alternative (with much broader applicability) to clinic-based interventions. Trauma survivors with mild TBI have limited access to rehabilitation services due to financial constraints and mobility and geographic restrictions that render clinic-based rehabilitation impractical. This clinical trial will recruit 90 trauma survivors with mild TBI and cognitive deficits in executive functioning. Eligible participants will be randomized to either 10-week (1) telephone-based GMT; (2) telephone-based attention-control; or (3) usual care. Primary outcomes will include observed and self-reported executive functioning and self-reported functional status as measured by a battery of standardized and previously validated cognitive tests and instruments, including the Delis-Kaplan Executive Function System Tower Test, the Dysexecutive Questionnaire, and the Functional Activities Questionnaire. Secondary outcomes will consist of depressive and PTSD symptoms, as measured by the Patient Health Questionnaire-9 and PTSD Checklist - Civilian Version, respectively. Outcome data will be collected at baseline (6 weeks after hospitalization) and at 4 month (treatment completion) and 7 month follow-up from hospital discharge. Our cognitive rehabilitation intervention will serve to broadly disseminate evidenced-based cognitive strategies to a trauma population that has difficulty returning to productive life both inside and outside the home due to profound functional and psychological disability. Findings from this study will support future research to improve the cognitive, functional and psychological health of patients following major trauma through innovative rehabilitation interventions and delivery methods.

This study seeks to compare two different behavioral treatments for pain in Veterans with a history of TBI. Both treatments involve educating the Veteran about pain, discussing the impact of pain, and different ways to manage it in hopes of decreasing pain and its impact on life. These approaches are called "self-management" approaches to pain. Both of these treatments are commonly used in pain clinics to treat pain in persons with back pain, headaches, and other types of chronic pain. The investigators will be delivering both treatments over the telephone to make the treatments accessible to Veterans wherever they live.

The purpose of this study is to determine whether sildenafil (Viagra®) is effective in improving cerebral blood flow and cerebrovascular reactivity inpatients who have persistent symptoms at least 6 months after a traumatic brain injury (TBI).

In the exploratory multi-center Phase 2 a study safety, tolerability, pharmacodynamics and pharmacokinetics of the Nitric Oxide Synthase inhibitor VAS203 is assessed in patients with moderate and severe traumatic brain injury. Traumatic brain injury patients (32 males) receive 15, 20 and 30 mg/kg VAS203, respectively, by continuous infusion in three cohorts (Cohort 1 open; Cohorts 2 and 3 double blind, randomised placebo-controlled). End of Study for all patients will be Day 14; adverse events and concomitant medications will be documented throughout the study. Objectives are to assess safety and tolerability of VAS203, to evaluate concentrations of metabolites of VAS203 in plasma and microdialysate and to assess pharmacodynamic effects of VAS203 on surrogate parameters. Safety parameter will include vital signs (blood pressure heart rate, respiration rate, oxygen saturation and blood gases), fluid balance, ECG, laboratory examinations (clinical chemistry, liver function, haematology/coagulation, urinalysis, renal parameters) and adverse events. Concentration of VAS203 will be determined in plasma and microdialysate. Pharmacodynamic parameters will include intracranial pressure (ICP), biochemical parameters in microdialysate (nitrite/nitrate, arginine, citrulline, pyruvate, lactate, glucose), Partial Oxygen Pressure in brain parenchyma and Therapy Intensity Level (TIL).

The purpose of this study is to determine if it is practical to treat moderately to severely brain injured patients who have problems with their balance and mobility in a group "boot camp" (3 days a week, 6 hours/day for 4 weeks) exercise class. If they show improvements compared to 4 weeks of not receiving this treatment If electronic daily monitoring of their center of foot pressure during a standardized balance task will allow us to see small changes in ability. A baseline assessment of all outcome measures will be performed. This will be repeated 4 weeks later. The intervention will be delivered (4 weeks) and a follow up assessment of all outcome measures will be performed one week later. A follow up of the Primary outcome measure, the PART-O participation questionnaire will be done 12 weeks later. Participants will attend group therapy consisting of a variety of exercises designed specifically to target balance and mobility deficits and based on the concept that through Repetitive Functional Task Practice (RFTP), recovery of function can occur as the result of neural adaptation. Exercises will be both individualized (delivered in a circuit) and group activities. Supervision and guidance will be provided by a registered Physical Therapist and a Rehabilitation Assistant. During the intervention, the amount and type of RFTP, any adverse events, and any need for extra staff will be recorded on a daily basis. As well, a standardized individualized task will be performed with center of foot pressure recording on a daily basis. Analysis: changes in outcome measures immediately after the non-intervention compared to the after the intervention period will be statistically determined to estimate efficacy of this treatment model. Descriptive measures of RFTP time/day, staffing levels/day and adverse events will be used to support feasibility and safety of this model.

The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after brain injury. This study will enroll 90 individuals with persistent problems 6 months to 10 years after a brain injury. These individuals will be randomized to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive 40 daily hyperbaric chamber sessions. Participants will have a series of tests and questionnaires before they begin their chamber sessions, after they complete 40 sessions, and 6 months after they joined the study. These tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain imaging, a neurological examination, and an eye exam. Participants will also be asked to provide blood for future research. After the 6-month tests are complete, all participants will receive 40 hyperbaric oxygen sessions, then undergo the same tests at 9 months and 12 months.

Blast-related and blunt traumatic brain injury is a key priority area of Rehabilitation Research & Development (RR&D) and represents a critically important public health problem facing the Veteran population. Developing efficacious treatments for persistent memory deficits seen in this population is a key step in reducing the impact that such problems have in the everyday lives of Veterans. Memory problems after TBI in Veterans are quite heterogeneous, and efficacy will likely be maximized by developing and disseminating multiple alternative treatments individually matched to the Veteran's key deficits, and by research that seeks to understand the cognitive and neural basis of treatment-related change over time. The results of this approach may aid clinical decision making and assignment of patients to rehabilitative treatments most likely to improve memory capacity and functional outcome.