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Concussion clinical trials

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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: NCT02069795 Completed - Concussion Clinical Trials

Speech Analysis as a Diagnostic Tool for Mild Traumatic Brain Injury

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

The waveform assessment of an athlete's speech production has a high probability of showing abnormalities after brain injury (concussions) which could be used not only for diagnosis of the concussion, but for recovery of the brain. The aim of this study is to investigate this possibility using the Cobweb automated application system for acoustic processing.

NCT ID: NCT02035579 Completed - Concussion Clinical Trials

Aerobic Training for Management of Post-Concussion Syndrome in Adolescents

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

Sports-related concussions are common in adolescent-athletes. Prolonged recovery after concussion or post-concussion syndrome (PCS) is a public health problem. This project will determine the effectiveness of an aerobic exercise program for management of PCS and it will evaluate the influence of exercise on biologic correlates of PCS.

NCT ID: NCT01978795 Completed - Concussion Clinical Trials

Interactive Training in Sports Concussion Prevention and Management

Start date: August 2011
Phase: Phase 2
Study type: Interventional

This study evaluated Brain 101: The Concussion Play book, an intervention that provides education and resources on concussion management for high schools. The study hypotheses were that athletes and parents who viewed the Brain 101 program would demonstrate increased knowledge and self efficacy in concussion management, and that use of the intervention would positively affect school concussion management practices.

NCT ID: NCT01936792 Completed - Concussion Clinical Trials

Pathology in the Brain After mTBI - A Multimodal MRI Study

Start date: August 2013
Phase: N/A
Study type: Observational [Patient Registry]

The purpose is to use Diffusion Kurtosis Imaging (DKI), Diffusion Tensor Imaging (DTI) and resting state functional MRI to examine tissue damage in the brains of people who have had a concussion, both acute and 3 months after the accident. A secondary purpose is to examine whether the results of the scans are associated with physical, cognitive and emotional problems after concussion. It is hypothesized that there will be a change in the diffusion signal measured with DKI in the thalamus (THA) and with DTI in the corpus callosum (CC), in the acute stage and at follow-up of the mTBI subjects compared with the healthy controls. Secondary it is expected that there will be changes in the diffusion signal measured with DKI and DTI in other WM and GM area in both the acute stage and at follow up with mTBI subjects compared with healthy controls. Also rs-fMRI markers are secondary expected to differ in the two groups. Moreover secondarily the MRI markers are tested for correlation with the severity of PCS acutely and at follow up after mTBI.

NCT ID: NCT01903525 Completed - Clinical trials for Mild Traumatic Brain Injury

DHA For The Treatment of Pediatric Concussion Related to Sports Injury

Start date: September 2013
Phase: Phase 1
Study type: Interventional

In recent years, media attention has focused on the long-term sequelae of repeated concussive episodes in professional athletes. The growing understanding of the damage done by what was once considered a "ding" during a game or match, and the neurologic consequences of "playing through" or returning to play too soon has led to additional interest in and concern for pediatric athletes (18 or under) who experience sports-related concussions during game or practice play. Because it has only been in recent years that the full scope of damage done by repeated concussive episodes has come to light, very little research has been done on treatment of concussion in either adults or children. Brain injuries in children can be especially problematic, as the brain may continue to develop until the child reaches the age of 24 or older, so concussion during this time of development may be particularly damaging. Docosahexaenoic acid (DHA) is an omega-3 fatty acid commonly found in both fish oils and algae. DHA is known to improve development of the eyes and brain in young children. It is thought to be an effective anti-inflammatory and anti-oxidant, and since it occurs naturally and causes very few harmful side effects, it may be a useful compound in the treatment of pediatric concussion. This is a feasibility trial of DHA for the treatment of sports concussion in a pediatric population. The investigators' primary aim is to determine acceptability of randomization for this compound as well as rate of enrollment given our clinical population. The investigators' secondary aim is to examine preliminary outcomes. The investigators hypothesize that subjects who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to play and a shorter time to resolve balance disturbance. These are good, albeit unvalidated, clinical indicators of concussive recovery.

NCT ID: NCT01809639 Completed - Concussion Clinical Trials

Does Oral Micronized Progesterone Shorten Time of Symptoms From Concussion

Start date: June 2013
Phase: Phase 4
Study type: Interventional

Concussions are a common injury among athletes in the United States. The annual incidence of sports and recreational related traumatic brain injuries in the United States is 1.6 to 3.8 million, and the likelihood of an athlete in a contact sport experiencing a concussion is as high as 20 percent per season. Even mild traumatic brain injury, including concussion, can cause long-term cognitive problems that affect a person's ability to perform daily activities and to return to school or work. Far more concerning is the mounting body of evidence that concussions are not just transient injuries - but have cumulative effects. It has been well established in animal models that progesterone has neuroprotective benefits. Animal studies using progesterone for acute post-injury treatment have demonstrated reduced cerebral edema, reduced neuro-inflammatory markers, decreased neuronal loss, and improved behavioral outcomes. To date, there have been no studies to assess whether or not progesterone will be effective for the treatment of concussions. This double-blind placebo controlled trial will assess the ability of 5 days of oral micronized progesterone (Prometrium®) to shorten the duration of symptoms of an athlete diagnosed with concussion. The investigators hypothesize that athletes treated with progesterone will have faster resolution of their concussive symptoms. The investigators believe this study may be the first clinical trial to show an effective treatment for concussion.

NCT ID: NCT01661075 Completed - Clinical trials for Mild Traumatic Brain Injury

Quantification of Balance in Acutely Concussed Athletes

Start date: August 2012
Phase: N/A
Study type: Observational

The purpose of this pilot project is to determine whether using inertial sensors placed on the waist during routine clinical balance testing (i.e. Balance Error Scoring System) (BESS), will be a more immediate, objective, reliable and sensitive way to measure and quantify balance deficits in individuals with mild Traumatic Brain Injury (mTBI). The investigators are also trying to observe if the sensors can be used to detect balance recovery after a mTBI. The investigators hypothesis is that collegiate atheltes with mTBI injury will have different recovery periods between their cognitive testing(IMPACT) and their balance measures.