Active clinical trials for "Brain Injuries"

The goal of this study is to investigate a new treatment for chronic symptoms after concussion or mild traumatic brain injury in people aged 18-65 years old. Chronic symptoms could include dizziness, headache, fatigue, brain fog, memory difficulty, sleep disruption, irritability, or anxiety that occurred or worsened after the injury. These symptoms can interfere with daily functioning, causing difficulty returning to physical activity, work, or school. Previous concussion therapies have not been personalized nor involved direct treatments to the brain itself. The treatment being tested in the present study is a noninvasive, personalized form of brain stimulation, called transcranial magnetic stimulation (TMS). The investigators intend to answer the questions: Does personalized TMS improve brain connectivity after concussion? Does personalized TMS improve avoidance behaviors and chronic concussive symptoms? Do the improvements last up to 2 months post-treatment? Are there predictors of treatment response, or who might respond the best? Participants will undergo 14 total visits to University of California Los Angeles (UCLA): One for the baseline symptom assessments and magnetic resonance imaging (MRI) Ten for TMS administration Three for post-treatment symptom assessments and MRIs Participants will have a 66% chance of being assigned to an active TMS group and 33% chance of being assigned to a sham, or inactive, TMS group. The difference is that the active TMS is more likely to cause functional changes in the brain than the inactive TMS.

Rapidly evolving virtual reality (VR) and augmented reality (AR) technologies are being incorporated by many large-scale industries, and the medical field is no exception. One area that has gained significant attention in recent years is virtual rehabilitation which allows physical therapists to leverage state-of-the-art immersive virtual environments to uniquely address functional deficits in patients who are unresponsive to conventional treatment techniques. Advanced VR and AR technologies are now available in commercially available small-scale, mobile head-mounted displays which can be readily used in outpatient clinic settings and possibly at home. The aim of this study is to determine whether advanced VR- and AR-based physical therapy improves functional status and reduces self-reported symptoms in individuals experiencing vestibular disorders secondary to mild traumatic brain injury (mTBI). Study participants will be randomized into treatment groups: 1) conventional therapy, 2) therapy performed using a large-scale VR system (the Computer Assisted Rehabilitation Environment or CAREN), 3) therapy performed using a mobile AR. Upon completion of treatment, groups will be compared to determine functional outcome improvements with respect to static and dynamic balance as well as reduction of vestibular symptoms.

The goal of this clinical trial is to evaluate GetUp&Go, a program for promoting increased physical activity in individuals at least 6 months post moderate-to-severe traumatic brain injury. GetUp&Go is a remotely delivered 10-week program that includes one-on-one sessions with a therapist and a mobile health application (RehaBot). The main question is whether participants in the 10-week GetUp&Go program increase their physical activity, and exhibit associated benefits in mental and physical health, relative to those who are put on a waitlist. Question 1: Do participants who receive immediate treatment with GetUp&Go show more increased physical activity, measured by accelerometer activity counts per day, and improve more on secondary outcomes, such as self-reported physical activity, emotional function, fatigue, sleep, pain, and health-related quality of life, compared to their baseline, relative to those who are put on a waitlist? Question 2: Do participants who have continued access to the mobile health component of the intervention, RehaBot, show better maintenance of physical activity gains compared to those who no longer have access to RehaBot? Question 3: Are individual participant characteristics associated with participants' response to the treatment program?

This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.

The purpose of this RCT is to examine the efficacy of a Group Lifestyle Balance™ (GLB) program adapted for people with traumatic brain injury (TBI) on primary (weight) and secondary outcomes at 3, 6, 12, and 18 months from enrollment into the program.

The purpose of this study is to test the effects of an innovative exercise program referred to as movement-2-music (M2M) on health and fitness outcomes in adults with physical/mobility disabilities. One hundred and eight participants with physical/mobility disabilities will be recruited and randomly enrolled into one of two groups: a) M2M or b) waitlist control. The primary aim of this study is to determine the effects of a 12-week M2M program on health and fitness in participants with physical/mobility disabilities who are in one of three functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II - able to exercise sitting and standing with/without support, and 3) Group III - able to exercise one side of the body more than the other side. The second aim is to compare the observed effects of the program in this study to a previous M2M study that groups participants based on disability type. The third aim of this study is to test whether adherence (defined as attendance to the 12-week program) affects the effects of M2M in participants with physical/mobility disabilities. The potential influences of different functional mobility and disabilities of participants on how the program affects participants' health and fitness outcomes will also be tested. **In response to COVID-19, the 12-week M2M intervention and all assessments have been modified from being delivered in-person at Lakeshore Foundation to being delivered remotely in real-time through videoconferencing technology.**

This study will test the effectiveness of an intervention for Veterans diagnosed with Alzheimer's Disease (AD) or Traumatic Brain Injury (TBI) and the burden on their informal (family/friend) caregiver.

There are an increasing number of people in the U.S. with Alzheimer's disease and other dementias. Traumatic brain injuries (TBIs) are also common among both civilians and military personnel, and TBIs increase a person's risk for dementia. Providing care for a person with dementia is stressful. Dementia caregivers can experience difficulties including stress, depression, and reduced quality of life. Coordinated dementia care is known to benefit people with dementia and their caregivers. However, many caregivers do not have access to these supportive programs. Our project studies the benefits of telehealth as a new way for caregivers to receive coordinated dementia care services. We will offer 75 caregivers a 12-month caregiver support program delivered using telehealth (for example phones, tablets, computers). Caregivers of both Alzheimer's disease and TBI-related dementia will be included, and the program will be evaluated for effectiveness in both groups as well as in a control group. The information from our study will help improve quality of life for caregivers and individuals with dementia, including military members and Veterans. Our results will also help both civilian and military health professionals develop effective programs to support families living with dementia. Policy makers and organizational leaders can use the information to fund programs that best help families and communities facing dementia and TBI dementia.

Veterans with traumatic brain injury (TBI) frequently experience insomnia, which is linked with delayed TBI recovery, more severe functional impairment, and exacerbation of disabling TBI after-effects such as depression, chronic pain, and fatigue. Current research suggests that TBI can impact numerous systems involved in sleep, suggesting that insomnia can have various causes and that a "one-size-fits-all" approach to treatment is likely inadequate. As such, it is necessary to determine which Veterans may benefit from standard evidence-based treatments, such as Cognitive Behavior Therapy for Insomnia, and which may require enhanced treatments targeting specific underlying mechanisms. An emerging body of evidence has established a link between circadian rhythm disruption and post-TBI insomnia. A mismatch between circadian and desired sleep timing (i.e., "circadian misalignment") is common following TBI, as evidenced by disruptions of key circadian rhythms involved in sleep regulation (e.g., melatonin production), as well as the onset of circadian rhythm sleep-wake disorders. Importantly, circadian-driven sleep disturbances require specialized treatments that target circadian rhythms (i.e., "chronotherapies"), such as timed sleep windows or enhanced light exposure, as standard treatment approaches can fail to address or even exacerbate the underlying circadian misalignment. Thus, circadian misalignment represents a novel and modifiable treatment target and has the potential to improve functional outcomes in Veterans with TBI and insomnia. Detection of circadian misalignment and optimal use of chronotherapies require the ability to measure circadian phase (i.e., timing of the central circadian clock). However, current sleep medicine in TBI is hampered by a lack of pragmatic options for measuring circadian phase. This is because laboratory dim light melatonin onset (DLMO), the gold standard measure of circadian phase, is time and cost prohibitive, requiring specialized sample (e.g., saliva) collection facilities and placing substantial burden on the patient. Recently, novel methods of DLMO measurement have been developed that may enhance the accessibility and practicality of circadian phase assessment, although, as of yet, they have not been used in Veterans with TBI. The proposed single-arm, longitudinal study seeks to evaluate the feasibility of two methods of measuring DLMO in the home environment of Veterans with TBI and insomnia: 1) direct measurement of self-collected salivary melatonin; and 2) indirect estimation of DLMO using activity and light-exposure data collected through actigraphy. Additionally, this study seeks to explore the relationships between circadian misalignment, sleep disturbance, and functional impairment in Veterans with TBI. The specific aims of this study are to: Aim 1) evaluate the feasibility of two methods of home DLMO measurement (i.e., self-collected salivary melatonin and actigraphy data) in Veterans with TBI and insomnia; and Aim 2) examine associations between circadian misalignment (i.e., the difference in timing between DLMO and attempted sleep onset), sleep disturbance, and functional impairment. Veterans with TBI and insomnia will be asked to wear a wrist-based actigraphy device for one week, which will collect data on light exposure and sleep-wake states. They will then be asked to self-collect seven hourly saliva samples under dim light conditions in their own home and mail them to a testing facility using a provided pre-paid shipping label. Saliva samples will be used to directly measure DLMO and actigraphy data will be used to indirectly estimate DLMO using established mathematical models of the human circadian pacemaker. Evaluating the feasibility of home DLMO measurement is a crucial first step for enhancing precision sleep medicine for Veterans with TBI and insomnia. Findings will inform the development and testing of tailored sleep interventions for use with this patient population.

This project is to evaluate sensitivity and specificity of hyperpolarized 13C-pyruvate as imaging agents of altered cerebral glycolysis and mitochondrial dysfunction and assess pyruvate utilization in mitochondria in Traumatic Brain Injury (TBI) patients.