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Head Injury clinical trials

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NCT ID: NCT06370520 Recruiting - Brain Injuries Clinical Trials

Screening Emotions in Adolescents at the Hospital for mTBI

SEARCH-mTBI
Start date: May 22, 2024
Phase:
Study type: Observational

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.

NCT ID: NCT06368050 Not yet recruiting - Sport Injury Clinical Trials

Implementation of an Evidence-Based Intervention to Improve Head Impact Safety in Youth Football

Start date: July 2024
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the feasibility of implementing an evidence-based intervention program, COmmunities Aligned to reduce Concussion and Head impact exposure (COACH) on a larger scale. Coaches of 12U (12 years old and under), and 13U (13 years old and under) teams within six youth football organizations will pilot test the intervention. Aim 1 will conduct focus groups with coaches, parents, and organizational leaders to assess organizational needs, capacity, and readiness to adopt the intervention program. Aim 2 will evaluate the effectiveness of the intervention program at reducing HIE and injuries and evaluate implementation success. Aim 2 results (intervention outcomes) are reported herein.

NCT ID: NCT06270680 Not yet recruiting - Head Injury Clinical Trials

Carotenoids for Collision Athletes

Start date: August 1, 2024
Phase: Early Phase 1
Study type: Interventional

This is a supplement study being conducted to find out if collision sport athletes who are exposed to repetitive head impacts while supplementing with carotenoids will have decreased pro-inflammatory blood biomarkers, increases in macular pigment optical density, improved contrast sensitivity, greater retinal nerve fiber thickness, and better overall visual quality of life scores compared to collision athletes taking a placebo.

NCT ID: NCT06073886 Not yet recruiting - Depression Clinical Trials

Personalized Brain Stimulation to Treat Chronic Concussive Symptoms

Start date: January 2024
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT05819489 Recruiting - Concussion, Brain Clinical Trials

A Comparison of Dynamic Vision & Balance Between College Athletes & Controls

Start date: August 31, 2021
Phase:
Study type: Observational

The purpose of this study is to determine the value of including dynamic vision testing into California State University, Northridge (CSUN) Athletics' established concussion protocol. The study's hypotheses are 1) dynamic vision testing will reveal vision impairments right after a person sustains a concussion, 2) these impairments may still be present upon clearance to return to play.

NCT ID: NCT05788146 Not yet recruiting - Stroke Clinical Trials

A Blended Psychological Intervention for Depression After Acquired Brain Injury

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

1.3 million people in the UK live with an Acquired Brain Injury (ABI) as a result of experiencing a stroke or traumatic brain injury (TBI). Up to 50% of individuals with ABI will experience depression. NICE guidelines recommend Cognitive behaviour therapy (CBT) for depression after ABI. There is growing interest into increasing access to CBT through mHealth technology, including mobile applications. Objective: Phase 1 of the study aims to investigate whether a blended psychological intervention, using a novel smartphone-based application alongside individual therapy sessions is acceptable and feasible for targeting depression after ABI. Phase 2 of the study aims to use qualitative interviews to better understand the participants' experiences of using the mobile app as part of the intervention. Methodology: The researchers aim to recruit 20 individuals with ABI, who are experiencing mild-moderate symptoms of depression. Participants will complete outcome measures and cognitive tasks at the beginning of the study. Participants will then receive a six-week blended psychological intervention; engaging the CBT-based mobile app alongside weekly, 30-minute video or telephone sessions for therapeutic and technology support. Participants will then be asked to complete the same outcome measures as completed at the beginning of the study. Participants will then be invited to take part in a 30-minute interview about their experience of using the mobile app as part of the intervention. Data Analysis: Change scores will be calculated from the data collected as part of phase 1 of the study, to investigate initial efficacy. Recruitment and dropout rates will help determine the feasibility of the blended intervention. In the 2nd phase, qualitative data will be analysed following Ritchie and Lewis (2003)'s Framework Analysis. Findings: Results from this study will help increase understanding into the acceptability and feasibility of using mHealth technology for treating depression following ABI. If effective, it could help to increase access to psychological interventions for individuals living with ABI. We hope to publish findings in a peer reviewed journal.

NCT ID: NCT05663034 Recruiting - Depression Clinical Trials

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

Start date: May 10, 2024
Phase: N/A
Study type: Interventional

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 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

NCT ID: NCT05629169 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Video Review of the Frequency and Assessment of Head Impacts During the FIFA World Cup 2022TM

Start date: November 20, 2022
Phase:
Study type: Observational

This is an exploratory observational study. Broadcasted video footage is used to review all head impacts during all 64 matches in the football tournament. All head impacts are registered, and simple descriptive statistics are used to create overviews of the head impact characteristics, including video signs of potential concussion, observed contact, location of the head impact, presence and timing of medical assessment, whether there was foul play and sanction, and if the player was substituted.

NCT ID: NCT05622461 Recruiting - Clinical trials for Traumatic Brain Injury

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

Start date: February 13, 2023
Phase: N/A
Study type: Interventional

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).

NCT ID: NCT05563129 Completed - Emergencies Clinical Trials

Teaching First Aid and Trauma Management to School Students

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

This proposal aims to describe research that will utilize first aid in primary education students and will attempt to identify the frequency with which the training should be repeated and the type of trainer who will carry out the training program.