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Brain Concussion clinical trials

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NCT ID: NCT04079907 Completed - Concussion, Brain Clinical Trials

Ketone Supplementation in Adolescents Post-Concussion

Start date: March 20, 2020
Phase: N/A
Study type: Interventional

Adolescent brains undergo rapid and significant changes in structural architecture and functional organization during development. A concussive injury during this developmental period can have substantial physiological and cognitive ramifications. If not adequately managed, adolescent concussions can have profound long-term effects. The purpose of this study is to determine whether ketone supplementation after a concussion will reduce long-term consequences and improve short-term functional status and outcomes in adolescents who have suffered a concussion.

NCT ID: NCT04074486 Completed - Brain Injuries Clinical Trials

Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC

BSC-CI-NPC
Start date: October 2, 2019
Phase:
Study type: Observational

This study is designed to collect data which will be used to associate changes in EEG, neurocognitive performance, eNPC and clinical symptoms in concussion subtypes. The study will recruit males and females, 13-50 years old, from Concussion Centers/Programs, Sports Venues and Emergency Departments (ED) across the country, over an 18-month period (Phase 2, 12 months for Algorithm Development and Norming, and Phase 3, 6 months for Validation).

NCT ID: NCT04068883 Completed - Concussion, Mild Clinical Trials

Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football and soccer playing athletes wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the efficacy of device to reduce alterations in brain structure relative to amount and magnitude of sustained head impacts. Finally, to show that DTI efficacy and safety results can be prospectively confirmed in a multi-school investigation. Test the null hypotheses of no difference between collar users and non-collar users changes from baseline to end of season for: - Primary: Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced in the neck collar group at EOS relative to BL. - Secondary: Alterations in pre-defined DTI metrics is explained by the number of hits, the hit intensity, and the intensity per head impact over the season non-collar users. In addition, secondary analytics on data derived from injury surveillance (musculoskeletal, concussion and symptom/severity scores), behavioral (Trail Making, Postural Sway, Flanker, Task-switching, Near Point Convergence, ADHD and King Devick) or imaging (DTI, fMRI, T1, T2, and MRS) will be evaluated.

NCT ID: NCT04044456 Completed - Clinical trials for Mild Traumatic Brain Injury

Combining Attention and Metacognitive Training to Improve Goal Directed Behavior in Veterans With TBI

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Veterans with mild traumatic brain injury continue to deal with symptoms that interfere with their ability to engage in productive activities. In combination with other psychosocial difficulties, impairments are found in cognition, such as attention and executive function. Few interventions are available to treat attention in Veterans with mTBI. Of the interventions available, none rigorously train attention combined with strategy training. This project will innovatively combine a strategy training called Goal Management Training with computerized attention training to improve tests of problem solving, attention and functional tasks compared to a control group.

NCT ID: NCT04036916 Completed - Concussion, Mild Clinical Trials

Sensorimotor Training for Injury Prevention in Collegiate Soccer Players II

Start date: August 12, 2019
Phase: N/A
Study type: Interventional

The purpose of this project is to evaluate the effectiveness of an injury prevention intervention delivered primarily using headset virtual reality for collegiate soccer players. The hypothesis is that measures of sensorimotor control will improve, injury incidence rate will decrease and on-field soccer performance will improve.

NCT ID: NCT04032509 Completed - Clinical trials for Mild Traumatic Brain Injury

A Study of Biomarkers of Mild Traumatic BRAIN Injury

BRAINI
Start date: August 10, 2019
Phase:
Study type: Observational

Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

NCT ID: NCT04012853 Completed - Clinical trials for Mild Traumatic Brain Injury

Remotely Supervised tDCS for Persistent Post-traumatic Headache

tDCS for PTH
Start date: November 4, 2019
Phase: N/A
Study type: Interventional

This pilot study is designed to provide preliminary data for a large scale, randomized clinical trial to evaluate the efficacy of remotely administrated at home transcranial Direct Current Stimulation (tDCS) with real-time monitoring via VA Tele-health for persistent post traumatic headache associated with mild traumatic brain injury (mTBI). Participants will receive total of 20 sessions of tDCS over four weeks. The investigators anticipate that the results generated from the study will directly translate into immediate meaningful clinical application: not only in management of chronic post traumatic headache, but also in reduction of acute pain medication use, and improving quality of life for our veterans with this debilitating neurological disorder.

NCT ID: NCT04001192 Completed - Clinical trials for Mild Traumatic Brain Injury

Exercise in Patients With Post-Concussion Symptoms

Start date: February 14, 2019
Phase: N/A
Study type: Interventional

Physical activity and exercise have traditionally not been much of a focus in treatment of postconcussion symptoms and posttraumatic headache. On the contrary, patients have often got advice to rest until they were free from symptoms. This approach, however, is challenged, and complete rest should probably be discouraged after the first 24-72 hours. Moderate aerobic exercise has been found promising in the early phase after sports-related concussion, and in the treatment of patients with headache. This study is an open pilot-study of guided, home-based exercise in a clinical sample with postconcussion symptoms and posttraumatic headache after mixed-mechanism mild traumatic brain injury and minimal head injuries. The study will result in data about the feasibility and possible effects of exercise as treatment for prolonged postconcussion symptoms and posttraumatic headache.

NCT ID: NCT03974360 Completed - Clinical trials for Mild Traumatic Brain Injury

Efficacy and Tolerability of Erenumab in the Prophylactic Treatment of Persistent Post-Traumatic Headache

Start date: April 5, 2019
Phase: Phase 2
Study type: Interventional

An exploratory open-label study of PPTH patients to study the efficacy and tolerability of erenumab in the prophylactic treatment of persistent headache attributed to mild traumatic injury to the head. Approximately 100 subjects will be included to erenumab 140 mg. Patients who have participated in study with prior provocation (Ethics Committee of the Capital Region of Denmark (H-1801147 and H-18050498) and who have consented to be contacted will primarily be included. The study will begin February 2019 and is expected to last one year. Patients responding to advertisement (see add) will be contacted by phone.

NCT ID: NCT03972579 Completed - Clinical trials for Mild Traumatic Brain Injury

Behavioral Profile Matching: A Precision Medicine Approach to Concussion Rehabilitation

Start date: May 15, 2019
Phase: N/A
Study type: Interventional

At least 1 in 5 people who sustain a concussion will have persistent symptoms and difficulties with daily activities. The researchers have identified two unhelpful coping styles following a concussion - avoidance and endurance. Individuals who engage in avoidance behavior may benefit from a different type of treatment than those who engage in endurance behavior. The researchers will evaluate whether assigning individuals to a specific psychologically-informed treatment tailored to their coping style is practical, acceptable, and beneficial for their recovery.