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Concussion, Brain clinical trials

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NCT ID: NCT04837066 Recruiting - Concussion, Brain Clinical Trials

Dynamic Vision Testing and Concussion Management

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: NCT04731974 Recruiting - Pediatric ALL Clinical Trials

Acute Concussion and Melatonin

Start date: March 1, 2023
Phase: Phase 2
Study type: Interventional

In this study, the investigator plans a randomized trial of melatonin versus placebo post acute pediatric concussion. The investigator hypothesizes that patients with acute concussions managed with melatonin will have improved sleep, decreased depressive symptoms, decreased risk of prolonged concussion symptoms and faster resolution of concussion symptoms.

NCT ID: NCT04688255 Recruiting - Clinical trials for Brain Injuries, Traumatic

Mobile Subthreshold Exercise Program for Concussion--R01

MSTEP-R01
Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Approximately 1.9 million youth sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) such as headache, dizziness, and difficulty focusing that continue for weeks or months. PPCS results in greater utilization of sub-specialty care and can impact immediate and long-term social development, cognitive function and academic success. Previous recommendations for treating PPCS have focused on cognitive and physical rest, but more recently guidelines have shifted based on new research suggesting the benefit of rehabilitative exercise for PPCS. The rationale behind using exercise to treat youth with concussion is that gradually increasing physical activity facilitates return to full function. Rehabilitative exercise has since become one of the most common approaches to treating youth with PPCS, but access is challenging since most programs require weekly centralized visits with a concussion specialist. To bridge this gap, the investigators developed a telehealth-delivered approach to treat PPCS, utilizing physical activity trackers (Fitbits) and weekly video conferences with trained research staff. They then conducted a series of pilot studies with this approach, finding excellent feasibility, acceptability, and evidence for more rapid declines in concussive symptoms compared to controls. The investigators also found preliminary evidence that mechanisms behind this intervention may stem from both physiologic processes due to increased moderate-to-vigorous physical activity (MVPA) and psychologic processes such as reducing fear- avoidance of concussive symptoms. They now propose a fully-powered randomized controlled trial (RCT) to asses the efficacy of the "Mobile Subthreshold Exercise Program" (M-STEP) for treating youth with PPCS.

NCT ID: NCT04279431 Recruiting - Concussion, Brain Clinical Trials

Follow-up of mTBI Patients Discharged From the ED Using Standard Clinical Triage Including BrainScope One

MEDO
Start date: May 25, 2020
Phase:
Study type: Observational

The purpose of the study is to validate the clinical outcome in patients with closed head injuries (GCS 14-15, ages 18-85) who are being evaluated for head trauma, integrating the BrainScope One structural injury classifier (SIC) algorithm, with focus on SIC negative classification. In addition, to assess functional impairment (concussion) in these patients, results from Brain Function Index (BFI) or Concussion Index (CI) algorithms will be used for analysis.

NCT ID: NCT04121780 Recruiting - Clinical trials for Growth Hormone Deficiency

Growth Hormone Replacement Therapy for Retried Professional Football Players

Start date: October 8, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension to evaluate the efficacy of growth hormone (GH) on cognitive functions of retired professional football players with growth hormone deficiency (GHD).

NCT ID: NCT04107844 Recruiting - Concussion, Brain Clinical Trials

Safe Return to Play After Concussion

Start date: February 10, 2020
Phase:
Study type: Observational

This study will evaluate a combination of a novel Dual-task regime together with other already known tests in terms of defining when an athlete is ready to return to play after a concussion.

NCT ID: NCT04076657 Recruiting - Concussion, Brain Clinical Trials

Efficacy of Brock String Therapy Post Concussion

Start date: November 9, 2020
Phase: N/A
Study type: Interventional

The purpose of the proposed study is to evaluate the efficacy of Brock String therapy prescribed in the acute stage of concussion recovery can improve clinical outcomes among patients with receded near point of convergence (NPC). Aim 1: Determine if participants receiving the Brock String have more significant improvements in NPC measurements at follow up 7-10 days post injury. Aim 2: Determine if participants receiving the Brock String 1) improve on computerized neurocognitive test scores from initial visit (<48 hours post injury) to follow up visit (7-10 days post injury) compared to control participants, and 2) have reduced recovery time (i.e., days from injury until return to play) compared to control participants.

NCT ID: NCT03892356 Recruiting - Concussion, Brain Clinical Trials

Oculomotor Function Testing in Acute Concussion

Start date: March 1, 2019
Phase:
Study type: Observational

This is a prospective longitudinal study which aims to compare oculomotor function and visual scanning behaviour (VSB) of participants who suffered concussion with healthy controls with no concussion. This study also aims to investigate the pattern of change in oculomotor function and visual scanning behaviour (VSB) in the participants over a 6-month period.

NCT ID: NCT03123224 Recruiting - Alzheimer Disease Clinical Trials

The COACH Project: Combined Online Assistance for Caregiver Health

COACH
Start date: August 2015
Phase: N/A
Study type: Interventional

This study evaluates the effect of a physical exercise + caregiver skills training on feelings of burden, mood, and biological markers of inflammation in persons who provide care for Veterans with a TBI or dementia. Half of the caregivers will participate in a balance and flexibility + caregiver skills training program, while the other half will participate in a moderate/high intensity aerobic and resistance + caregiver skills training program.

NCT ID: NCT03104244 Recruiting - Concussion, Brain Clinical Trials

Longitudinal Brain Health in Youth Tackle Football Players

Start date: July 2016
Phase: N/A
Study type: Observational

The purpose of this study is to determine the neurologic and cognitive effects of playing tackle football in grade school and high school. During contact practices and games, players wear a football helmet containing an impact sensor. Before and after each season, players complete neurological testing to measure several different aspects of brain function. Two groups of football players will be in the study: 5th and 6th grade tackle football players from the Brighton Bulldogs Football and Cheer league (about 70 players). Varsity football players from Brighton High School (about 70 players per year). The study begins in July 2016 and will continue for 4 years (through the winter of 2020).