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Concussion, Mild clinical trials

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NCT ID: NCT05769296 Completed - Concussion, Mild Clinical Trials

Australian UCSF Concussion in Athletes

AUSSIE-1
Start date: June 1, 2021
Phase:
Study type: Observational

Analysis of cardiac induced brain forces using cranial accelerometry has been shown to diagnose concussion in high school athletes. This trial expands on this observation by recording headpulse signals in a recently concussed athletes playing Australian rules football.

NCT ID: NCT05741411 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Facilitating Access to Specialty Treatment

Start date: March 11, 2024
Phase: N/A
Study type: Interventional

The goal of this hybrid implementation-effectiveness study is to evaluate the effectiveness (hastened recovery times) and feasibility (fidelity in connecting to concussion specialty care) of a novel mobile health intervention, designed to reduce disparities in access to specialty care through the use of remote patient monitoring (RPM) to facilitate care hand-off from the emergency department (ED) to concussion specialty care. Participants will report their symptoms and activity once daily through RPM chat technology that is linked to their electronic health record and prompts referral to specialty care.

NCT ID: NCT05675956 Completed - Concussion, Mild Clinical Trials

Acute Nerve Stimulation For Enhancing Human and Cognitive Performance

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test a wearable device's effect on performance in tactical populations with a history of concussion. The main question it aims to answer is the effectiveness of the device on modulate physiological and cognitive function. The physiological function will be derived from metrics of heart rate variability and blood-based biomarkers, whilst human performance will be evaluated using tasks that assess cognitive domains of executive function, reaction time, and memory.

NCT ID: NCT05660356 Not yet recruiting - Clinical trials for Growth Hormone Deficiency

Growth Hormone Deficiency in Mild Traumatic Brain Injury

Start date: February 2023
Phase: Early Phase 1
Study type: Interventional

The goal of this randomized control trial is to test if growth hormone therapy is a safe and effective treatment for patients suffering from growth hormone deficiency and persistent post-concussion symptoms. The main questions it aims to answer are: 1. Is growth hormone therapy effective at mitigating persisting post-concussion symptoms in patients with growth hormone deficiency? 2. Is it feasible to conduct a larger trial to examine efficacy of growth hormone therapy in patients with persistent post-concussion symptoms and growth hormone deficiency? Participants will be asked to complete an initial assessment for study inclusion and to complete clinical outcome questionnaires. If a participant meets study criteria they will be randomized to receive either growth hormone therapy (provided by Pfizer) or a placebo (provided by Pfizer). Participants will be instructed on how to self-administer their assigned drug daily for three months. Monthly follow-up visits will include a blood draw to measure a biomarker and clinical outcome questionnaires. At the final follow-up visit after three months, participants will learn what group they were assigned and given the option to complete the growth hormone therapy if they were originally assigned to the placebo group. Researchers will compare the growth hormone therapy group to the placebo group to identify any potential differences in outcomes.

NCT ID: NCT05623046 Recruiting - Concussion, Brain Clinical Trials

Building Emotional Self-Awareness Teletherapy (BEST)

BEST
Start date: February 23, 2023
Phase: N/A
Study type: Interventional

To examine the feasibility, acceptability, and preliminary efficacy of a remotely delivered intervention for civilians and service members with mild traumatic brain injury (mTBI) who have difficulty recognizing and regulating their emotions. Post-treatment outcomes of interest include emotional self-awareness and regulation, resiliency, and affective symptoms.

NCT ID: NCT05588115 Not yet recruiting - Concussion, Mild Clinical Trials

Rapid, Accurate, Cost-effective Assessment of Blood Biomarkers for Diagnosis of Concussion

RACE
Start date: December 2022
Phase:
Study type: Observational

The goal of this observational study is to test if a biosensor can accurately measure a blood biomarker in adult patients presenting to the emergency department with concussion. The main questions it aims to answer are: - Does the biosensor measure the blood biomarker of interest with the same accuracy as the current gold-standard assay technique? - Do relationships exist between blood biomarker measurements from the biosensor and any psychological or physical symptoms of concussion? Participants will be asked to provide blood samples at initial visit and 2-, 6-, and 12-weeks after injury while completing questionnaires at each visit, along with a brief (2 min) daily symptom inventory. Researchers will compare the concussion group to a muscle/skeletal injury group to see if measurements from the biosensor are exclusive to concussion.

NCT ID: NCT05473897 Recruiting - Concussion, Mild Clinical Trials

Cooling Helmets to Decrease Concussion Symptoms

ColdCon
Start date: June 23, 2022
Phase: N/A
Study type: Interventional

Current therapy of Mild traumatic brain injuries (TBI) revolves around symptomatic care, rest, and return to school/sport/work after symptoms have resolved. The standard intervention for sufferers of mild traumatic brain injury is brain rest, which aims to decrease symptom intensity and duration, prevent re-injury and second impact syndrome via cessation of physical and cognitive activity, and to gradually increase activity as tolerated. Increased brain temperature can be a secondary injury result in TBI. There are limited studies, primarily in the sports medicine literature, that show head-neck cooling can be a useful adjunct as a treatment for mild TBI. Our objective will be to evaluate concussive symptoms via the Post-Concussion Symptom Severity Score Index by conducting patient follow up interviews at different timepoints over 72 hours after an emergency department visit for the head injury where head and neck cooling was applied.

NCT ID: NCT05262361 Recruiting - Clinical trials for Mild Traumatic Brain Injury

Persistent Post-Concussion Symptoms With Convergence Insufficiency

PPCS-CI
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Our successful R01 discovered 1) the neural mechanistic difference between typically occurring convergence insufficiency (TYP-CI) and binocularly normal controls and 2) the underlying mechanism of office-based vergence and accommodative therapy (OBVAT) that is effective in remediating symptoms. Adolescent and young adult concussion is considered a substantial health problem in the United States where our team has shown that about half of patients with persistent post-concussion symptoms have convergence insufficiency (PPCS-CI), causing significant negative impact associated with reading or digital screen-related activities, and is believed to be one factor causing delayed recovery impacting return to school, sports, or work. The results of this randomized clinical trial will impact the lives of adolescents and young adults with PPCS-CI to guide professionals on how to manage and treat those with PPCS-CI by 1) comparing the differences between PPCS-CI and TYP-CI, 2) discovering the neural mechanism of OBVAT for PPCS-CI compared to standard-community concussion care, and 3) determining the effectiveness of 12 one-hour sessions compared to 16 one-hour sessions of OBVAT.

NCT ID: NCT05105802 Recruiting - Concussion, Mild Clinical Trials

Mindfulness-Based Intervention for Mild Traumatic Brain Injury

MBI-4-mTBI
Start date: October 4, 2022
Phase: N/A
Study type: Interventional

Mindfulness is a promising tool which may foster adaptative interpersonal qualities to reduce the risk of persistent post-concussion symptoms. The present feasibility study will customize and validate a mindfulness mobile smart-phone app easily accessible to youth and families. The study will also determine whether mindfulness training increases quality of life, reduces symptom burden and promotes neurophysiological recovery at 4 weeks post-injury in adolescents who were diagnosed with an acute concussion compared to a cognitive sham app + usual care.

NCT ID: NCT05069948 Completed - Concussion, Mild Clinical Trials

Delivery of Digital Cognitive Behavioural Therapy Following Concussion

HEADON
Start date: November 8, 2021
Phase: N/A
Study type: Interventional

Concussion is common and patients can go on to suffer with a constellation of symptoms which impacts their functional outcome and quality of life. Patient provision with information about their concussion and subsequent follow-up is highly variable. The investigators have developed HeadOn - a web application that delivers a CBT programme to patients following concussion. In this study, the investigators would like to examine the feasibility of digitally delivering a course of CBT to patients following concussion.