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Concussion clinical trials

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NCT ID: NCT02370914 Completed - Concussion Clinical Trials

Concussion Testing: A Novel Non-invasive Concussion Detection Device

Start date: August 2011
Phase:
Study type: Observational

The purpose of this study is to establish and evaluate a distinctive signal for concussion.

NCT ID: NCT02344446 Completed - Dizziness Clinical Trials

Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion

Start date: November 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate if skilled physical therapy treatment for dizziness after sports-related concussion, delivered after greater than 30 days post-concussion is effective to remediate physical symptoms. This will be the first study that explores differential PT treatment for dizziness in concussed athletes who have physical symptoms 30+ days after concussion. The findings of this important research have great potential to influence clinical practice and place increased emphasis on and acceptance of manual skills and neuromotor training in the treatment of concussed patients with dizziness.

NCT ID: NCT02278029 Completed - Concussion Clinical Trials

Driving Performance of Teenage Patients With mTBI: a Longitudinal Assessment

Start date: October 2014
Phase: N/A
Study type: Observational

This study will synthesize a behavioral profile of impaired driving performance for teenage patients with mild traumatic brain injury (mTBI), or concussion, from one week post-concussion to six weeks post-concussion. It will also elucidate the relation between decreased reaction times exhibited by these patients and their functional response to driving hazards. While a few studies have examined driving performance in adult patients with mTBI, to the investigators knowledge this will be the first investigation of driving performance for teenage patients with mTBI. Therefore, it will provide the foundation for the future development of return-to-drive protocols for physicians and clinical practitioners. This study will synthesize a behavioral profile of impaired driving performance for teenage patients with mild traumatic brain injury (mTBI), or concussion, from one week post-concussion to six weeks post-concussion. It will also elucidate the relation between decreased reaction times exhibited by these patients and their functional response to driving hazards. While a few studies have examined driving performance in adult patients with mTBI, to the investigators knowledge this will be the first investigation of driving performance for teenage patients with mTBI. Therefore, it will provide the foundation for the future development of return-to-drive protocols for physicians and clinical practitioners.

NCT ID: NCT02271451 Completed - Concussion Clinical Trials

Q-collar and Brain Injury Biomarkers

Start date: October 2014
Phase: N/A
Study type: Interventional

Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge costs currently being experienced for life-treatment of surviving victims. An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs, LLC (Q30). Initial research suggests that the Device has the potential to reduce the likelihood of TBI. The currently developed collar (Smith 2009; Smith 2011; Smith 2011; Smith 2012) has been approved for studies in humans and the results indicate safety for use during high demand and maximal exertion activities, Study ID: 2013-2240, Institutional Review Board - Federalwide Assurance #00002988). Regarding safety, the externally worn collar is meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins that will provide similar pressure and volume increases not to surpass that of a yawn or the mere act of just lying down. This study will investigate the effectiveness of this device in high school athletes playing a collision or contact sport such as football, hockey, or lacrosse. The high risk sports which utilize helmets during competition will allow for measurements systems to be embedded in the headgear and will not affect play or fit of equipment. Athletes participating in this study will be enrolled into one of two groups 1) device wearing or 2) non-device wearing. By the nature of the sports selected, it is likely this pilot study will primarily include males, however if any female meets inclusion criteria on the team selected they will be included in this pilot investigation. The helmets of all participants will be outfitted with an accelerometer which will measure the magnitude of every impact to the head sustained by the athlete. Effectiveness of the device will be determined by brain imaging during the pre-season, midseason, and end of season time points. A subset of athletes who report a diagnosed concussion will also receive additional brain imaging within the week following the diagnosed concussive event.

NCT ID: NCT02268240 Completed - Concussion Clinical Trials

Care for Post-Concussive Symptoms

CARE4PCS
Start date: October 2014
Phase: N/A
Study type: Interventional

The proposed study is a pilot randomized trial of a stepped collaborative care intervention designed to decrease post-concussive symptoms and improve post-injury functioning among sports-injured youth aged 11-17. Participants with persistent post-concussive symptoms (symptoms persisting at least two months post-injury) will be recruited from Seattle Children's Hospital departments of sports medicine and rehabilitation medicine. Consent and assent will be obtained in-person. Participants will be randomized to receive either the stepped collaborative care intervention, or treatment-as-usual. Participants will be assessed on a range of symptoms and areas of functioning at four time points: 0 months, 1 month, 3 months, and 6 months after enrollment. The primary hypothesis is that the intervention group athletes, when compared to usual care control group athletes, will demonstrate clinically and statistically significant reductions in postconcussive, anxiety, and depressive symptoms over the course of the 6-month study. Secondary analyses will assess the impact of the intervention on functional impairment including missed school days and other academic outcomes. Exploratory analyses will examine MRI findings that are characteristic of postconcussive neuropathology, if available in medical record, as predictors of treatment responses.

NCT ID: NCT02268058 Completed - Headache Clinical Trials

Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children

Start date: October 2013
Phase: N/A
Study type: Interventional

Concussions and headache are a significant problem for children and athletes. While headache generally resolves within 7-10 days; a significant proportion of children, 72-93% experience prolonged headache as a symptom of Post Concussion Syndrome (PCS). The prevailing clinical view is that mild head injuries resolve with little chance of complications. However, the reality is quite different. Concussion in children presents with a range of severity and results in both short and long-term physical, cognitive, emotional and behavioural sequelae known as PCS with varying times to resolution. To date there are no specific treatments for headache pain related to concussion. Physical and cognitive rest is the mainstay of initial concussion management. The number of children presenting to ED's with a history of concussion and headache is increasing. Presently there are no evidence based guidelines available to guide the medical team to effectively and consistently manage their headache. Our present standard of care is based on the CANCHILD concussion guidelines outlining the child's return to school and activity. Yet, our present standard of treatment is compromised and somewhat counterproductive if we are not treating the child's headache pain. Our pilot study ' An Open Label Randomized Control Pilot Study Examining Treatment of Headache In The Post-Concussive Youth' showed that routine administration of oral analgesia improves the child's headache symptoms and helps with school re-entry one week post injury, compared to a standard care group defined as non routine administration of pain medications.

NCT ID: NCT02262507 Completed - Clinical trials for Traumatic Brain Injury

Concussion Device Audiological Measures

Start date: September 2013
Phase: N/A
Study type: Interventional

Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge costs currently being experienced for life-treatment of surviving victims. An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs, LLC (Q30). Initial research suggests that the Device has the potential to reduce the likelihood of TBI. The rationale for testing wideband absorbance and Oto-acoustics emissions (OAE) is that the investigators need a physiologic, non-invasive method to evaluate the brain responses to mild jugular compression across multiple age groups. To determine this with MR imaging is currently cost prohibitive. The investigators pilot data from the parent IRB indicates a consistent response measured via wideband absorbance in young adults. Therefore, a preliminary step to evaluate the safety and efficacy of the neck collar device is to employ this technology across a wide range of ages.

NCT ID: NCT02257749 Terminated - Clinical trials for Mild Traumatic Brain Injury

Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion

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

The purpose of this randomized control trial study is to determine if an active rehabilitation (low intensity exercise program) in combination with a comprehensive education intervention (standard care) is more effective than the comprehensive education intervention alone in reducing post-concussion symptoms and improving participation in daily activities in youth who have persistent post-concussion symptoms.

NCT ID: NCT02119533 Terminated - Clinical trials for Stress Disorders, Post-Traumatic

Concussion and Post Traumatic Stress in Traumatic Brain Injury

CAPIT
Start date: May 2013
Phase: N/A
Study type: Observational

Mild brain injury or concussion affects about four million Americans each year. Some people recover completely while others, especially those with multiple concussions, develop chronic headaches, neurodegenerative diseases and psychiatric disorders. One of the reasons that concussion is difficult to treat is that it is difficult to detect. Radiographic studies such as CT (computed tomography scan) are by definition unrevealing of structural injury in concussed patients. Some MRI (magnetic resonance imaging) sequences may be useful adjuncts in the diagnosis of concussion but even these are not consistently present in all patients with symptoms. Clinical tests for concussion often require baseline studies, and thus are generally reserved for athletes and others at highest risk for concussion. The investigators have developed a novel eye movement tracking algorithm performed while subjects watch television or a music video that determines whether the eyes are moving together (conjugate) or are subtly not together (disconjugate). The investigators preliminary data shows that people with lesions in their brain or recovering from brain injury have disconjugate gaze that is not detectable by ophthalmologic examination but is detected by our algorithm.

NCT ID: NCT02100150 Terminated - Concussion Clinical Trials

A Safety and Efficacy Study of NNZ-2566 in Patients With Mild Traumatic Brain Injury (mTBI)

Start date: September 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the treatment of mTBI in adolescents and adults.