20 Clinical Trials for Various Conditions
The project will examine the neural associations of alcohol approach-bias and investigate the extent to which a neuroscience-based personalized cognitive training program will remediate alcohol approach-bias and improve recovery outcomes among heavy drinking Veterans with alcohol use disorder (AUD) and a history of mild-moderate traumatic brain injury (mmTBI). Alcohol approach-bias modification (ApBM) is a cognitive training intervention designed to interrupt and modify automatic approach processes in response to alcohol cues. Modification of alcohol approach-bias and reductions in heavy alcohol use can be expected to reduce behaviors of self-harm and violence, increase adherence to medical care, reduce drinking-related medical costs, and promote healthier relationships. The long-term goal is to demonstrate the efficacy of ApBM to promote recovery from AUD in Veterans with chronic mmTBI. The investigators also aim to identify neural mechanisms associated with ApBM and other neurocognitive predictors of successful recovery. The evidence garnered from this study will be useful to inform the development of other behavioral and pharmacological treatments for Veterans with AUD with a history of mmTBI.
The purpose of this small, research study is to examine effectiveness of an at-home application of an experimental intervention, on thinking and memory in mild-moderate, closed-head, traumatic brain injury cases. The experimental intervention is light-emitting diode (LED) therapy, which is applied to the scalp and through the nose using a head frame device. Participants are expected to complete two, 5-week series of LED treatments, at home, 3 times a week. There will be a 1-month period between the two series. Each home treatment is 20 minutes. Participants will be trained to use the head frame device, in-office. The head frame device falls within the FDA category General Wellness, low-risk devices, and no medical claims are made. A two-hour paper and pencil testing (4 visits) and a one-hour MRI (3 visits) will be administered before and after each treatment series. Participants may be in the study for about 4 months. This study is supported by Vielight, Inc., Hayward, CA/ Toronto, Canada
Test the hypothesis that a certain set of osteopathic manipulation procedures preformed on patients with mild to moderate traumatic brain injury will result in accelerated rates of recovery assessed using vestibular function tests, quality of life questionnaires and measurements of the levels of anti-inflammatory metabolite and protein biomarkers in the blood and urine.
The investigators hypothesis is that electrical stimulation to the tongue that directly stimulates two cranial nerve nuclei (Trigeminal and Facial Nerve Nuclei), will excite neural impulses to the brainstem and cerebellum. The investigators call this cranial nerve non-invasive neuromodulation (CN-NINM). The activation of these structures induces neuroplasticity when combined with specific physical, cognitive and/or mental exercises, promoting recovery of selected functional damage such as problems with balance or walking. 44 subjects will be recruited for 2 weeks of intensive In-Lab Balance and Gait Training followed by 12 weeks of intensive Home Training with weekly In-Lab check sessions. Half of the subjects will use CN-NINM in conjunction with the exercise. Half of the subjects will use very low level stimulation in conjunction with the exercise, and will serve as a control group.
The purpose of this study is to assess if putative brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI. The assay will be evaluated in a sample population of subjects over the age of 18 who have been referred to the health care provider for closed head injury evaluation.
The purpose of this study is to determine whether memantine (Namenda) improves memory and attention in patients with mild to moderate traumatic brain injury.
- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.
- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.
- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.
- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.
- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device. Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.
The wars in Iraq and Afghanistan are creating a new generation of Veterans, including an increasing number of women Veterans, who present with comorbid PTSD and chronic pain conditions from recent deployment-related physical injuries and exposure to psychological trauma. Health behavior change has become increasingly important in treating these conditions and proactively preventing long-term negative health sequelae, in order to benefit these Veterans directly and reduce the growing challenges to the healthcare system. The proposed CDA-2 program of research will use an innovative translational research approach to study whether a chronic progressive -based exercise program will reduce chronic pain symptoms in patients with varying degrees of PTSD symptom severity and to elucidate and modify potential PTSD-related deficiencies in neurobiological and psychological responses to exercise to optimize the physical and psychological benefits of exercise for these individuals.
The primary objective of this study is to evaluate the safety and tolerability of long-term (12 months) armodafinil treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
The primary objective of the study is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI).
This is a research study that aims to examine whether Veterans with mild Traumatic Brain Injuries are at risk for dementia by studying their memory, brain wave activity, brain structure and proteins that can be elevated after brain injury and in dementia.
The purpose of this research is to learn if different behavioral interventions can change walking behaviors over 12-weeks, in older adults who have previously suffered a non-penetrating mild or moderate TBI. Participants will provide information and be screened for eligibility via phone screening call (verification of age, confirmation that the participant is not currently on any medication that affects the central nervous system, and verification that the subject can participate in exercise, brief TBI history). Baseline testing will take place at the Center for Cognitive and Brain Health and Northeastern University Biomedical Imaging Center, for the baseline magnetic resonance imaging, in the interdisciplinary science and engineering complex on Northeastern University's campus. In person testing will take place over one session. The study period lasts 12 weeks, during which all participants will 1. Receive a weekly phone call with study staff and 2. Wear a wrist-worn Fit Bit tracker. A remote participation option is available for those who cannot travel to Northeastern University.
Approximately 5.3 million people live with a long-term disability resulting from a traumatic brain injury (TBI) and between 5-8% of those older than 60 suffer from Alzheimer's disease or other forms of dementia (ADRD). Consequences of these conditions can result in dramatic and persistent changes in functioning, impacting not only the patients, but also loved ones who become informal support persons. Many existing services help the family in the moment, but do not address long-term wellness. Thus, the purpose of this research study is to compare the effect of two different types of group wellness treatments for individuals with chronic mild TBI, moderate to severe TBI, and ADRD and their support persons.
Today's hospitals need innovative solutions to help patients transition from our care to self-management at home. The vast majority of the patients seen in Dodd Rehabilitation Hospital and associated clinics leave our care with persistent and life-altering challenges - behavioral, cognitive, emotional and/or physical. The period of time immediately following discharge is an under-addressed stage within the continuum of care. The investigators are researching solutions to help patients in this transition to self-care and believe that multiplayer gaming paradigms may be a promising innovation to facilitate this transition. The investigators believe that Dr. Jane McGonigal's SuperBetter, and positive play games like it, are promising novel interventions that could make a positive difference in the ability of our patients to successfully transition to self care after discharge from therapeutic care. Specifically, the investigators will evaluate feasibility of use of such a game by mild to moderate brain injured individuals and to record pilot data to help us plan a clinical effectiveness follow up study. Our goal is to finish this study with an intervention tailored for use within the clinical continuum of care and sufficient pilot data to prepare for a randomized clinical control trial of this intervention.
The purpose of this study is to determine if specific brain injury biomarkers have utility as blood-based traumatic brain injury (TBI) diagnostic and monitoring tools. This will be accomplished by examining the relationships between potential serum-based TBI biomarkers and clinical measures of injury severity, occurrence of complications, and outcome, in subjects with mild or moderate TBI as well as in orthopedic control subjects.
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.