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Concussion clinical trials

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NCT ID: NCT03958110 Completed - Concussion Clinical Trials

Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players

ON RUGBY
Start date: July 15, 2020
Phase:
Study type: Observational

The main hypothesis is that exposure to repeated shocks is associated with a greater decrease in the thickness of optical nerve fibres. In order to show a association between the occurrence of concussions (in number and severity) and the variation in the thickness of the retinal nerve fibre layer, all participating rugby players will have an ophthalmologic examination (OCT and (retinophotography) at the beginning and end of the Rugby season.

NCT ID: NCT03908112 Not yet recruiting - Concussion Clinical Trials

Interventions for Convergence Insufficiency in Concussed Children

ICONICC
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

The ICONICC Study is a randomized controlled clinical trial designed to compare the proportion of successful treatment outcomes between children assigned to standard concussion care only, standard concussion care plus simple convergence procedures, or standard concussion care plus office-based vergence/accommodative therapy in children aged 11 to 17 years with symptomatic post-concussion syndrome. Children with post-concussion syndrome (4-12 weeks post-concussion injury) and symptomatic CI will be randomized to a 12-week treatment program of either standard concussion care (SC), SC plus simple convergence procedures (SC+), or SC plus office-based vergence/accommodative therapy SC+OBVAT (1:1:1 ratio). The study will also compare the effect of treatment on clinical measures of both accommodation and vergence, symptom level/burden, health-related quality of life, clinical measures of saccadic eye movement, and objective eye movement measurements of disparity vergence, saccadic function, and accommodative function. The attainment of objective eye movement measures provides an opportunity to understand the underlying neurophysiology of the vergence and accommodative systems. Objective eye movement recordings are powerful because of the rich foundation from primate single-cell recordings that show a direct correlation with vergence and accommodative parameters in the supraoculomotor area of midbrain2, 3 and the oculomotor vermis of the cerebellum.4, 5 Thus, a combined approach of acquiring both clinical vision function measures and objective eye movement recordings in children with PCS-CI may lead to better characterization of the oculomotor phenotype with subsequent improved and personalized therapeutic interventions.

NCT ID: NCT03710109 Recruiting - Concussion Clinical Trials

Evaluation of an EEG Based Concussion System

Start date: October 23, 2018
Phase:
Study type: Observational

This study will evaluate the accuracy of a new concussion system at detecting concussions. The investigators will be evaluating the degree to which data collected with the device agrees with a physician's determination of a concussion. The system captures an electroencephalograph (EEG) potential when a light is flashed into the eyes of an individual. The device is not FDA approved, but it is a non-significant risk device. The device is a non-invasive, non-interventional sensor. It will not replace the opinion of the physician in diagnosing a concussion. This study will test the EEG based concussion system on 200 individuals, Participants will be made up of individuals who are seeking medical consultation at the Play Safe Concussion Clinic (10 Union Square E, New York, NY 10003) or at Mount Sinai Hospital (1468 Madison Ave, New York, NY 10029) after experiencing a head trauma. The Play Safe Clinic treats patients who reach out to Mount Sinai Physicians via the Play Safe telephone number: 212 241 2221. The doctors who see patients these locations will be involved in conducting this research. In addition to the standard-of-care clinical assessments, participants will also receive an evaluation from the concussion based system. When a subject experiences a head trauma, the subject will be evaluated for a concussion by both the standard-of-care clinical assessments. The treating physician will provide all necessary standard-of-care evaluations and diagnostic procedures needed to properly diagnose and treat each patient and by the new concussion system. The researchers will also collect data from healthy, age-matched controls in order to collect a database of healthy responses to the technology. To determine how accurate the new concussion system is at detecting concussions, the research team will compare the diagnostic results from the device to the diagnostic results of the doctor's assessments. The goal of this study is to develop a device that can give sound advice as to whether an individual should seek medical attention for a possible concussion following a head injury.

NCT ID: NCT03608722 Active, not recruiting - Dementia Clinical Trials

Video Games to Track Cognitive Health

Start date: November 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to assess cognitive function using a rapid, portable, computerized neurocognitive testing device in a wide variety of clinical settings.

NCT ID: NCT03360786 Recruiting - Concussion Clinical Trials

Primary Prevention of Concussion in Youth Ice Hockey Players

Start date: October 4, 2017
Phase: N/A
Study type: Interventional

1. Background and Rationale: Little is currently known about intrinsic risk factors for sport-related concussion in youth ice hockey players. Emerging research suggests that alterations in cervical and balance function increase the risk of concussion in youth ice hockey players. Thus, evaluation of a primary prevention program aimed at addressing alterations in cervical and vestibular function may result in a protective effect in reducing the risk of concussion. Such a program targeting intrinsic risk factors for concussion has not previously been evaluated and thus a pilot Randomized control trial (RCT) to inform the feasibility and efficacy of such a program is needed prior to proceeding to evaluation of such a program on a larger scale. 2. Research Question and Objectives The primary objectives of this pilot RCT study are: 1) To evaluate the feasibility of a concussion prevention program in youth ice hockey players; and 2) To evaluate the efficacy of a concussion prevention program in decreasing the risk of concussion. Exploratory objectives include evaluating the changes in quality of life, clinical measures of cervical and vestibular function measures and Hockey Canada on-ice skills testing in youth ice hockey players following a concussion prevention program. 3. Methods This study will be a pilot RCT. Prior to the 2017 hockey season, 120 players from 8 youth ice hockey teams ages 13-17 will be recruited to participate. Once parental consent and/or player assent has been obtained, players will complete a series of initial intake forms. Baseline tests and measures, including a standardized preseason baseline questionnaire (regarding playing history, past medical history, participation in sport) and a battery of questionnaires and clinical measures. Individuals will be randomly allocated into either a control protocol (general cardiovascular warm-up, general stretching and strengthening, education on concussion identification) or a specific protocol (balance, neuromotor control, strength, vestibulo-ocular and oculomotor training + concussion education). Both groups will meet with the study physiotherapist once weekly for 4 weeks and exercises will be progressed. A previously validated prospective injury surveillance system will be implemented. As part of this process, a team designate will collect data throughout the season regarding individual player participation in games, practices and dry land training sessions. Individuals with a suspected concussion will be referred to the study sport medicine physician for evaluation, diagnosis and standard of care management. At this time all baseline tests and measures will be repeated.

NCT ID: NCT03304327 Completed - Concussion Clinical Trials

Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)

(MYTAC)
Start date: September 27, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to establish the tolerability of mindfulness and yoga therapy in the post-concussion period.

NCT ID: NCT03233646 Recruiting - Multiple Sclerosis Clinical Trials

Retinal Imaging in Neurodegenerative Disease

Start date: July 20, 2017
Phase:
Study type: Observational

This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.

NCT ID: NCT03230656 Completed - Clinical trials for Mild Traumatic Brain Injury

Cognitive-Communication Screening and Early Therapy for Adults With Mild TBI

Start date: January 2017
Phase: N/A
Study type: Interventional

Approximately 15-20% of patients diagnosed with a concussion/mild traumatic brain injury (mTBI) have persistent symptoms that continue up to six months or longer. Typical problems identified by these patients include difficulty with memory, multi-tasking, the ability to complete tasks quickly, and higher executive functions (e.g., inhibition, initiation, insight, motivation) (Belanger & Vanderploeg, 2005; Mott, McConnon, & Rieger, 2012, Rabinowitz & Levin, 2014). If these symptoms persist they can not only affect thinking, but also communication abilities (e.g., verbal and nonverbal interactions, reading, and writing) (ASHA, 2007). Therefore, it is hypothesized that screening measures that evaluate both thinking and communication can better identify individuals at-risk for persistent symptoms at two week and four weeks post-injury. Also, if cognitive-communication therapy was administered earlier post-injury, then outcomes related to return to daily activities, work, and/or the academic setting could possibly change. This study intends to investigate the use of cognitive and communication screening measures for the identification of persistent symptoms and the provision of early cognitive-communication therapy if problems persist.

NCT ID: NCT03213730 Completed - Brain Concussion Clinical Trials

Perceptual-Cognitive Training After a Mild Traumatic Brain Injury: Towards a Sensitive Marker for Recovery

Start date: January 10, 2017
Phase: N/A
Study type: Interventional

This study is part of a larger, multi-centered project done with the collaboration of University Of Victoria. This study holds three separate studies on the mild traumatic brain injured population and the use of perceptual-cognitive training (3D-MOT).

NCT ID: NCT03103529 Active, not recruiting - Concussion Clinical Trials

Safety and Feasibility of Early Active Rehabilitation in Children After Concussion

Start date: May 2016
Phase: N/A
Study type: Interventional

It has been suggested that activity immediately following concussion is detrimental to recovery and may lead to long term impairments. The animal model has shown that exercise too soon can lead to neurometabolic energy imbalances within the brain. However, there is also evidence to suggest that prolonged inactivity has negative consequences that may contribute to prolongation of symptoms. Determining the ideal timeframe in which to initiate an active rehabilitation protocol for patients who are slow to recovery is an important factor in concussion management.