130 Clinical Trials for Various Conditions
The purpose is to test how osteopathic medicine (OMM) improves recovery after a hit to the head during Mixed Martials Arts (MMA). The small changes in the bone, joints, and fluids during head injuries may lead to traumatic brain injury (TBI). The OMM is adjusting the body with the doctors' hands. The goal is to restore alignment and release tension. The head is treated with the doctors' hands placed gently on the head or face. It was previously found to improve symptoms and recovery of memory after head injuries in college athletes. There haven't been clinical trials of this procedure in MMA fighters. Yet, they often get injuries to the part of the brain that releases hormones. Referrals for tests for the hormones are available. Individuals who participate in MMA fighting or sparring matches may join this study. Those who don't get hit in the head or a concussion will contribute to our understanding the osteopathic structural physical exam and fluid dynamics of the head in relation to brain function tests. Those who get hit in the head may be put in the treatment procedure or sham-placebo group. Participants will not be told which group they are in. We anticipate that 100 individuals of any gender will enroll in this study at NYIT Academic Health Care Center (AHCC). To be in this study, the participant must: Part 1 - Before the fight: 1. Plan to participate in an MMA fight or sparring match, 2. 18 to 50 years of age, 3. Be able to do online cognitive neuropsychology tests for memory, reaction time, and symptoms. Part-2-After the fight: (1) Have been hit in the head, or had a head injury, during a fight The participant cannot be in this study if they have: Part 1- Before the fight: 1. a current or previous spinal cord injury, 2. a traumatic brain injury within the past six months, 3. inability to tolerate the sports physical, 4. a diagnosis of brain degeneration, 5. low hormones levels from the brain, 6. Pregnancy Participants won't get referred for hormone testing if they don't have any clinical signs of this injury. They also won't get referred for it if they've had heart disease, disease of the blood vessels in their brain, or seizures. Participants cannot be in Part-2-After the fight if they: 1. cannot tolerate OMM (For example, you have a skull fracture, cervical spine fracture, bleeding or increased pressure in the head, tearing of tissues in the neck, space-occupying lesion, or stroke). 2. were knocked out for more than 2 minutes, had seizures, persistent vomiting, or paralysis when your head was hit. Participation involves 2 or 4 visits, which will take place over one week. * The first visit takes 30 mins. in-person and 70 mins. of online testing from home. * The second visit takes 30-60 mins. in-person and 70 mins. of online testing from home. * The third \& fourth visits will each be 30 mins. in-person and 70 mins. online testing from home. If participants agree to be in this study, they will be asked to do the following: Visit #1: Before the Fight * Get screened and review the consent form * Take the neuropsychology tests (ImPACT and Inquisit Web) online from home * Get a non-invasive sports physical exam of head, neck, back, arms, and legs. * Urine sample for the hormone from the brain called oxytocin (optional) * Have blood sugar checked by a lancet after pricking the finger (optional) Fight video: The study-doctors will record the participants' fights to make a computational model of the head. Visit 2: After the Fight * Get a sports physical of head, neck, back, arms, and legs. * IF the participant was hit in the head, the study-doctors or participants private doctor will examine them. * Take the ImPACT and Inquisit Web tests online from home * If the participant had an injury to their brain, they may get the OMM procedure or sham placebo-control (non-therapeutic light touch). * Urine sample for the hormone from the brain called oxytocin (optional) * Have your blood sugar checked by a lancet after pricking your finger (optional) * Referral to your doctor to test the levels of other brain hormone (optional) Visit 3 \& 4: * Sports physical of head, neck, back, arms, and legs * Take the ImPACT and Inquisit Web tests online from home * If you had an injury to your brain, you may get the OMM procedure or sham placebo-control (nontherapeutic light touch). You will not be told which one you are getting. * Urine sample for oxytocin (optional) * Have blood sugar checked by a lancet after pricking your finger (optional) * Referral to test the levels of other brain hormone (optional) Any significant new findings that develop during research that may relate to the participants health or willingness to continue will be provided to them by phone call. The results will help us understand head injuries, how well OMM works to treat them, and may improve future care for fighters.
The purpose of this research is to explore potential methods of rehabilitating changes observed from repetitive head impacts. Participation in this study will involve functional magnetic resonance (fMRI) imaging, aerobic testing, heart rate variability (HRV) wrist monitor, hypercapnia challenge, a meditation rehabilitation intervention, and filling out survey information concerning subjective well-being.
The investigators are assessing the platelet function analysis of those who sustained significant head trauma while on aspirin or plavix and to assess if any qualitative difference is obtained if platelets are administered.
The goal of this observational study is to develop and validate a clinical tool to predict which adolescents aged 11 to less than 18 years of age with mild traumatic brain injury (mTBI) are at an increased risk for developing significant new or worsening mental health conditions. The main aims the study wish to answer are: * Does the adolescent have new or worsening depression or anxiety defined as a change from their previous medical history using self-reported questionnaires at either one or three months post-injury? * Does the adolescent have unmet mental health care needs, defined as not receiving any mental or behavior health care in patients with new or worsening anxiety or depression as defined by the self reported questionnaires? Participants will be enrolled after being diagnosed in the emergency department (ED) with an mTBI. During the ED visit, the child's parent/caregiver and the adolescent will complete several questionnaires related to mental health which include tools to measure anxiety and depression. Participants will be asked to complete these questionnaires again at 1 month and 3 months post enrollment.
The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Mbarara Regional Referral Hospital (MRRH) who have sustained or who are suspected to have sustained head trauma.
A Pre-post Study Evaluating the Safety and Efficacy of Ibogaine-Magnesium Therapy in Veterans with Sequelae of Repeated Blast Exposure.
The goal of this study is to determine the sensitivity, specificity, and positive and negative predictive values of the a portable near-infrared-based device (portable NIR-based device), the InfraScanner 2000™, to detect intracranial hematomas (epidural hematomas (EDH) and/or subdural hematomas (SDH)) in patients hospitalized at Duke University Hospital (DUH) who have sustained or who are suspected to have sustained head trauma and have consequently received a brain computed tomography (CT) scan(s).
The observation through a chart review of persistent pain on neuro psychological functioning and how it applies to the community integration with patients that had suffered traumatic brain injury.
The purpose of this study is to assess the prevalence of GHD in patients who sustain a head injury or suffer a major traumatic event and to evaluate the efficacy of growth hormone (GH) therapy in the treatment of GHD caused by trauma or head injury
This study aims to determine whether a blood test can help doctors decide when to use a head CT scan for patients with a mild head injury. Researchers are investigating whether the results from this blood test can aid in making better decisions about patient care and potentially reduce the need for imaging. In this study, researchers will collect blood samples to assess whether this specific blood test can help doctors decide when head imaging is necessary following a head injury. The goal is to determine whether the use of this test can reduce the number of head imaging procedures performed in the emergency department (ED).
The purpose of this Phase 2, double-arm study is to identify repetitive, non-concussive head impacts that impair neurologic functioning, and to test treatments that can mitigate these effects and return functioning to normal as quickly as possible.
Traumatic brain injury (TBI) is a major public health concern, particularly among older adults (OAs) ≥ 65 years of age. Each year in the United States, TBI results in over 600,000 emergency department visits and hospitalizations among OAs. Mild TBI (mTBI) accounts for 80% of all TBI in OAs and is quite understudied in this rapidly growing population. mTBI, is mild in name only, as it can result in dysfunction in multiple cognitive domains, including attention, processing speed, executive functioning and memory and has been shown to be associated with progressive brain atrophy and increased susceptibility to neurodegenerative disorders. Cognitive rehabilitation therapy is an evidence-based approach that can successfully improve cognitive impairment following TBI. Virtual reality (VR) is emerging as a technology that can assess cognitive impairment and provide a neurorehabilitation modality (NRM) to improve cognitive decline post TBI. Not only can VR provide a variety of environments like those encountered in real life and be adapted to varying levels and types of cognitive disability, but it can also be used safely in a patient's home with minimal equipment. Yet, despite the promise of cognitive rehabilitation using VR among OAs, very few studies to date have assessed the efficacy of VR cognitive rehabilitation in TBI. The aim of this study is to assess the effect and collect data on the efficacy and feasibility of a virtual reality application as a neurorehabilitation modality on executive functioning (attention, immediate memory, and visual-spatial skills) in OAs with mTBI. The hypothesis is that The use of VR mediated cognitive exercises post mTBI will be associated with improved executive function at 6-weeks post-randomization compared to the control group.
This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).
The Center for Neuroscience and Regenerative Medicine (CNRM) Clinical Trials Unit has developed the first cognitive-behavioral therapy (CBT) digital therapeutic (DTx) mobile application to counteract depressive symptoms in military service members and veterans with a history of mild traumatic brain injury (mTBI). This trial will assess the efficacy of the novel CBT-DTx for depression following mTBI compared to an educational comparison DTx.
The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in the diagnosis and prognosis of patients with mild traumatic brain injury, by incorporating blood biomarkers, clinical assessments, and tools to measure associated neurocognitive impairments.
Background: Patients with mild blunt traumatic brain injury (TBI) are frequently transferred to Level 1 trauma centers (L1TC) if they have any positive finding of any acute intracranial injury identified on a CT scan of the head. The hypothesis for the study is that patients with such injuries and minor changes on the Head CT scan can be safely managed at community hospitals (CH). Methods: Patients with blunt, mild TBI (defined as a GCS 13-15 at presentation) presenting to CH, L1TC, and transferred from CH to L1TC between March, 2012 and February, 2014 were included. Minor changes on head CT were defined as: 1) epidural hematoma\<2mm; 2) subarachnoid hemorrhage\<2mm; 3) subdural hematoma\<4mm; 4) intraparenchymal hemorrhage\<5mm; 5) minor pneumocephalus; or 6) linear or minimally depressed skull fracture. TBI-specific interventions were defined as intracranial pressure monitor placement, administration of hyperosmolar therapy, or neurosurgical operation. Three groups of patients were compared: 1) those receiving treatment at CH, 2) those transferred from CH to L1TC, and 3) those presenting directly to L1TC. The primary endpoint was the need for TBI-specific intervention and secondary outcome was death of any patient.
This prospective observational study will examine the incidence of intracranial hemorrhage. The investigators will compare patients on anticoagulant and/or antiplatelet therapy with head trauma compared to patients not on these medications. While many studies have sought to quantify the incidence of intracranial hemorrhage in these patients, there is considerable controversy regarding their care and what to do after an initial negative head CT in anticoagulated geriatric patients who have experienced head trauma.
This study will compare administration of N-Acetyl Cysteine (NAC) versus placebo for the treatment of olfactory loss due to head injury. The hypothesis is that treatment with NAC acutely after head injury will result in improved olfactory function
Family dynamics and caregiver responses to a child with traumatic brain injury are implicated both as precipitating events as well as factors influencing outcomes of abusive head trauma (AHT). However, no family behavioral health intervention exists to meet the unique needs of families with infants and very young children with AHT. The study was initially designed as a randomized controlled trial (RCT) to assess the efficacy of an evidence-based behavioral intervention to improve outcomes for families and children with AHT. However, rates of recruitment were so low that the investigators and funder amended the study to be intervention only (with IRB approval). At that time, there were five participants and only one had been assigned to the intervention arm. Only one additional family was recruited, and that family did not complete study measures prior to the time at which the intervention would start and did not receive the intervention. The investigators did examine outcomes in multiple dimensions, including clinical, cognitive, family, caregiver, child behavior, and service usage over time but connot compare to patients not receiving the intervention. The investigators were not able to examine characteristics of patients and families best suited for this behavioral health intervention.
Pediatric head trauma is a leading cause of morbidity and mortality for children/adolescents. The current standard of care regarding imaging modality when concerned for an acute head injury is CT. This exposes children to radiation that may predispose to future malignancy. Rapid MRI is a test that eliminates radiation and has expanded uses in multiple other areas. This study is evaluating it for pediatric acute head trauma.
Cognitive skills are essential to live independently, manage finances, maintain employment, and function in society. Loss of these cognitive skills puts a tremendous burden on society as seen with dementias, Alzheimer's disease, and traumatic brain injury. The INSIGHT-ICU Study (Illuminating Neuropsychological dysfunction and Systemic Inflammatory mechanisms Gleaned after Hospitalization in Trauma-ICU Study) is the first comprehensive and longitudinal long-term cognitive impairment study after traumatic injury. The societal impact of long-term cognitive impairment after trauma is immense given that these patients are young and constitute a large proportion of employable adults.
By studying individual biomarkers in body fluids such as saliva, there is a potential for detecting injury to the brain resulting from an acute traumatic even that may not be detectable by conventional neuroimaging like CT scans.
The primary objective of the clinical trial is to evaluate the effect of time on levels of Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of head injured subjects over the age of 18 presenting acutely with a Glasgow Coma Scale score 13-15 as well as in a group of uninjured control subjects.
The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive subjects (as determined by an independent Neuroimaging Review Committee) presenting acutely with traumatic brain injury (Glasgow Coma Scale score 9-15).
Recently, researchers and clinicians have examined many different forms of concussion testing aimed to assess if a brain injury has occurred and to what degree it affects the individual being tested. Due to the multifaceted and complex presentation of concussive injuries and the unknown effects of repeated head trauma, it is unlikely that a single test of physiological or behavioral function will reflect the full range of injury-related damages from a concussive event or from a series of cumulative head traumas, as well as the injury response within brain tissue. However, by combining a variety of objective assessments which may detect structural and functional alterations following head trauma into a single study, a clearer understanding of the multi-faceted presentation resulting from head trauma may be identified. The identification of biomarkers and the utilization of objective and clinically feasible tools will provide a method to assess three domains across multiple systems affected by head trauma: 1) the prognostic value of initial concussion assessments to identify injury severity and factors responsible for prolonged recovery, 2) the temporal window of recovery and potential vulnerability of brain tissue post-injury, and 3) the long-term alterations associated with repeated head trauma exposure.
Interventions to help individuals with traumatic brain injury manage their healthy lifestyle behaviors have been limited. Thus, the goal of this project is to evaluate the efficacy of a telehealth lifestyle program on reductions in weight and improvements in health behaviors/lifestyle choices.
The primary purpose of this research is to evaluate the impact of a telehealth-based, cognitive behavioral therapy (CBT) intervention (problem-solving training: PST) for adult informal military family/friend caregivers of OIF/OEF service members with a deployment-related TBI.
The investigators will test the impact of a decision aid, Head CT Choice, to determine if its use improves parents' knowledge and engagement in decision making and safely decreases healthcare utilization in children presenting to the emergency department with blunt head trauma.
After a head injury, many people find that exposure to light causes them increased discomfort. By measuring how the pupil in the eye constricts to flashes of red and blue light, this study will investigate whether this phenomenon is due to a change in the eye's sensitivity to light.
The objective of this study is to determine if the administration of platelets will improve outcome in patients with ICH who are being treated with either aspirin, a thienopyridine (ticlodipine, clopidogrel, prasugrel) or a combination of both. The study has four specific aims: 1. To determine what affect platelet administration will have on bleeding in the brain. 2. To determine what affect platelet administration will have on brain function. Several assessments to test the functioning of the brain will be performed at enrollment and throughout the study. Comparing the results of these assessments between the experimental and control groups should allow us to determine if platelet administration improves outcomes in patients with bleeding in the brain exposed to antiplatelet therapy. 3. An important risk of reversing antiplatelet therapy is exposing the patient to the very complications this therapy was designed to prevent. Therefore, tracking complications will be a very important part of this study. The investigators will compare the rates of death, heart attack, stroke and clots in the veins between groups. 4. Some patients (10-40%) have limited responsiveness to antiplatelet therapy. While platelet responsiveness, as measured by a special platelet blood test, will not affect enrollment, the investigators feel it will be important to measure.