Clinical Research Directory

Personalized Brain Stimulation to Treat Chronic Concussive Symptoms

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: 1. Does personalized TMS improve brain connectivity after concussion? 2. Does personalized TMS improve avoidance behaviors and chronic concussive symptoms? 3. Do the improvements last up to 2 months post-treatment? 4. 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): 1. One for the baseline symptom assessments and magnetic resonance imaging (MRI) 2. Ten for TMS administration 3. 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.

Healthcare Services for Older People Who Have Fallen With Potential Head Injury

Every year, one in three older people (\>65 years old) experience a fall. Older people may have long-term health conditions and take medications that can increase their risk of bleeding (blood thinners). The UK national guidelines recommend that older people who are on blood thinning medications should have a CT head scan considered due to concerns of a brain bleed if they have hit their head after a fall. Many older people are therefore brought into hospital for assessment. However, the risk of bleeding in the brain is very low especially if older people do not have any symptoms such as loss of consciousness, weakness, headaches or vomiting. Some people could experience long waits in the emergency department or end up being admitted to hospital unnecessarily. This could worsen mobility, cause confusion, pressure sores or infections in older people. More importantly, older people should have a comprehensive falls assessment to reduce their risk of future falls and have their medications reviewed after experiencing a fall. These assessments could potentially take place in their own homes if they prefer, rather than in hospital. Yet, current healthcare services outside the hospital setting may not be set up to manage an older person after fall. Using an online survey, the investigators want to understand how current healthcare services in the Hampshire and Isle of Wight (HIOW) region work to look after older people who have had a fall. The study will focus particularly on older people taking blood thinning medications who may have a head injury but do not have any symptoms. The investigators will ask NHS workers what their role is, where they work and what they do when assessing an older person who has fallen if there is a concern about head injury. The survey will also ask participants to describe what challenges they may face, and if they have any suggestions to improve the care for older people. This study will help the investigators understand what services are available in our current healthcare system for older people on blood thinning medications who have fallen and may have a head injury. The investigators hope that the results will help improve how healthcare services can work together with older people and their closed ones to provide care based on what matters most to them in their preferred place of care. This could reduce unnecessary use of emergency services and hospital admissions for older people.

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

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).

Biomarker Role in Assessing Imaging Needs for Mild Cranial Trauma

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).

Delayed IntraCranial Hemorrhage in Oral AntiCoagulant Treated Patients With Mild Traumatic Brain Injury

As a low quality, weak recommendation, it is part of the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults, that patient with a GCS of 14-15 and anticoagulation therapy and a normal CT should be admitted for observation for at least 24 hours. No data are available on the adverse events related to the observational 24-hour admission. The aim was to evaluate the risk of post-CT hemorrhage as well as the risk of complications to an admission (e.g. deleria, thrombosis due to pause of antithrombotic medications.

Screening Emotions in Adolescents at the Hospital for mTBI

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.

Setting Families on a Positive Path to Recovery After Pediatric TBI: Road-to-Recovery

This study has two main goals: 1) to refine and enhance the R2R-TBI intervention; and 2) to examine the efficacy of the R2R-TBI intervention in a randomized control trial. To achieve the second goal, we will employ a between-groups randomized treatment design with repeated measures at baseline, one-month post-randomization, and at a six-month follow-up. The two conditions will be: a) usual medical care plus access to internet resources regarding pediatric brain injury (Internet Resources Comparison group, IRC), and b) usual medical care plus the R2R-TBI intervention (Road-to-Recovery group, R2R-TBI).

The "Concussion or Brain Bleed" Trial

Researchers are trying to understand the effect of educating patients and encouraging shared decision making on rates of CT scanning in head injured patients by using an already developed app and observing the effect on the health care provider.

AI-powered Portable MRI Abnormality Detection

This study aims to test a new AI-powered portable MRI scanner that can quickly identify whether a brain scan is normal or abnormal. Currently, standard MRI scans are expensive and have long waiting times. Our goal is to see if a smaller, cheaper, and more accessible MRI scanner-combined with artificial intelligence (AI)-can help doctors identify abnormalities faster and improve patient care. We will invite patients from King's College Hospital (KCH) who are already having a standard MRI scan. They will be asked to have an extra scan using the portable MRI, which takes about 60 minutes. The AI tool will then analyse these scans and compare its results to those of expert radiologists. By the end of the study, we hope to prove whether portable MRI with AI can be used in hospitals and GP clinics, making brain scans more accessible, reducing wait times, and helping doctors prioritise urgent cases. This study is funded by the Medical Research Council (MRC) and has been approved by UK research ethics committees.

Characteristics of the Anosmic Olfactory Mucosa

The present study aims to describe the structural tissue and cell characteristics of the olfactory mucosa in patients with persistent anosmia (≥2 years) due to COVID-19 or head-trauma, in comparison to healthy individuals with intact olfactory function. In order to avoid possible age-related degenerative changes in the neuro-epithelium, both patients and controls are between 25 and 35 years of age.

Selective CT for Anticoagulated Head Injured Patients

The goal is to derive and a clinical decision rule for safe exclusion of traumatic brain injury without neuroimaging in head-injured ED patients who take anticoagulant medications. The objectives are to: 1. Derive and externally validate a new highly sensitive and maximally specific clinical decision rule for the exclusion of traumatic brain injury in head-injured ED patients who take anticoagulant medications; and, 2. Estimate the sensitivity and specificity of existing head injury clinical decision rules in head-injured ED patients who take anticoagulant medications.