Treatment Trials

14 Clinical Trials for Various Conditions

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RECRUITING
Facilitating Access to Specialty Treatment
Description

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.

COMPLETED
Building Emotional Self-Awareness Teletherapy (BEST)
Description

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.

COMPLETED
EYE-SYNC Concussion Classification Study
Description

The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for sport-related concussion evaluation.

COMPLETED
Ketone Supplementation in Adolescents Post-Concussion
Description

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.

COMPLETED
Objective Brain Function Assessment of mTBI/Concussion
Description

This study (Part 3) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery.

COMPLETED
Validation of Brain Function Assessment Algorithm for mTBI/Concussion
Description

This study is Part 2 of data collection from 13-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT02957461 (Part 1 with subject age range 18-25 years) for the final analyses of validation of the algorithms.

COMPLETED
The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
Description

Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise volume will be monitored throughout.

WITHDRAWN
Use of Adipose-Derived Stem/Stromal Cells in Concussion and Traumatic Brain Injuries
Description

Concussion is the most common type of brain injury throughout life. Study is seeking improvement of long-term residua following adolescent and adult post-traumatic injuries often associated with contact sports and accidental causes. Typically defined as reversible head injury with temporary loss of brain function. Symptoms range from physical, cognitive, pain (headache) and emotional signs consistent with TBI and Post-Traumatic Stress Syndrome. Use of AD-cSVF parenteral delivery to encourage repair of damage and decreased function following concussion, particularly in contact, repetitive sports injuries. Range of damage is measured in Grade I-III according to graduated severity. Unfortunately, less information is available about repetitive concussions and the long-term health issues.

COMPLETED
Validation of Brain Function Assessment Algorithm for mTBI/Concussion in College Athletes
Description

This study is Part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT03671083 (Part 2 with subject age range 13-25 years) for the final analyses of validation of the algorithms.

COMPLETED
Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
Description

The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED) or concussion clinic.

COMPLETED
Objective Brain Function Assessment of mTBI/Concussion in High School Athletes
Description

This study (Part 2) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery. In addition, neuroimaging will be conducted at time of injury and following Return to Play (RTP).

COMPLETED
Objective Brain Function Assessment of mTBI/Concussion in College Athletes
Description

This study (Part 1) is designed to build a database including EEG, neurocognitive performance, clinical symptoms, history and other relevant data, which will be used to derive a multimodal EEG based algorithm for the identification of concussion and tracking of recovery. In addition, neuroimaging will be conducted at time of injury and following Return to Play (RTP).

COMPLETED
Assessment of Oculomotor, Vestibular and Reaction Time Response Following a Concussive Event
Description

This study is designed to evaluate the use of a collection of tests that measure the eye response, balance, oculomotor and reaction time tests to aid in the diagnosis of mTBI. The tests use highly precise measurement tools to assess various neurologic functions. (For example, high-speed cameras to record eye movement, high-end motors to precisely spin and move the subject, comprehensive analysis to stitch together the stimulus and the response.) Hypotheses: 1. A battery of oculomotor, vestibular and reaction time tests will generate variables that when properly weighted and run through a given multi-variant analysis, will separate the subjects into one of two groups, mTBI or not-mTBI. 2. A battery of neurologic assessment tests including reaction time, vestibular and oculomotor tests taxing a range of neurologic functions and executed using one or more of the I-Portal® family of devices, will generate responses that, when used by a trained physician, can aid in the diagnosis of an mTBI.