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Brain Injuries clinical trials

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NCT ID: NCT02480985 Active, not recruiting - Clinical trials for Traumatic Brain Injury

The PIT-TBI Pilot Study

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

Damage to the pituitary gland is a frequently overlooked but potentially important complication of traumatic brain injury (TBI). Disorders of the pituitary gland can cause dysfunction of the thyroid, adrenals, ovaries and testes. These disorders may occur immediately or several months after TBI, may delay recovery and may have a significant negative impact on quality of life. TBI is the leading cause of disability and major permanent functional impairment among adults under 45 years of age. Hormonal deficits may contribute to common symptoms experienced by TBI survivors such as fatigue, poor concentration, depression and low exercise capacity. However, the association between hormonal deficits and disability remains uncertain. The primary objective of this pilot study is to assess the feasibility of a larger study that will evaluate the impact of pituitary disorders on neurological disability and functional recovery. The results of this study will provide key findings in the impact of pituitary disorders following TBI, which is a mandatory step prior testing the effect of hormonal replacement therapy in this population in costly clinical trials. If no relationship between pituitary disorders and disability is observed, the investigators' findings will prevent unnecessary, time-consuming and costly hormonal screening and will discourage potentially harmful hormonal therapy.

NCT ID: NCT02477943 Completed - Clinical trials for Brain Injuries, Traumatic

Objective Brain Function Assessment of mTBI/Concussion in College Athletes

AheadCAS
Start date: August 8, 2015
Phase:
Study type: Observational

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).

NCT ID: NCT02475226 Completed - Brain Injuries Clinical Trials

Cases With Traumatic and Non Traumatic Brain Damage Treated in the Intensive Care

Start date: April 2015
Phase: N/A
Study type: Observational

Cases of traumatic and nontraumatic brain damage have high rates of morbidity and mortality. In this study of cases being treated in the ICU for a diagnosis of brain damage, it was aimed to evaluate the relationship between mortality and the distribution of reason for and resulting type of brain damage and to determine other factors affecting mortality.

NCT ID: NCT02475044 Recruiting - Clinical trials for Post-Concussion Syndrome

Mild Traumatic Brain Injuries in Children: Predicting Behavioral and Emotional Deficits

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

The purpose of this study is to investigate the role of psychosocial factors in creating Persistent Post-concussive symptoms (PPCS). The researchers investigate three hypotheses: (a) Do pre-injury psycho-environmental deficits predict a higher level of PPCS? (b) Do socio-demographic and personal pre-injury deficits relate to (1) a more negative attribution for the child injury by their parents and (2) embracing of a more permissive and authoritarian parenting; and do these factors mediate the symptoms' preservation? (c) Does Cognitive-Behavioral Therapy (CBT) benefit to reducing PPCS emotional and behavioral symptoms?

NCT ID: NCT02471625 Active, not recruiting - Clinical trials for Traumatic Brain Injury

Traumatic Brain Injury Feasibility Study (EPIC-011)

TBI
Start date: April 2015
Phase: N/A
Study type: Observational

The purpose of this research study is to evaluate whether data made by the ClearView System can be used to detect whether someone has a traumatic brain injury and how severe the injury is.

NCT ID: NCT02465242 Recruiting - Clinical trials for Traumatic Brain Injury

Pupillometry for the Prediction of Neurologic Outcomes in Severe Traumatic Brain Injury

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

Traumatic brain injury (TBI) is a major cause of morbidity and mortality in the US. The CDC states that 1.7 million people sustain a traumatic brain injury each year, with death occurring in 52,000 of these injured patients. It is also estimated that 275,000 yearly require hospitalization. The costs of TBI can be devastating to our society, with the 2010 economic cost estimated to be approximately $76.5 billion. 90% of this cost involves fatal or hospitalized brain injured patients. Furthermore, survivors of traumatic brain injury have high rates of institutionalization, readmission, and disability. The prediction of prognosis in severe TBI is a difficult problem for physicians. Prognosis evaluation in the acute phase of care varies widely among physicians caring for these patients[3]. With prognosis often in doubt, physicians have difficulty leading families and patients toward the most appropriate treatment which often leads to expensive testing and patient management. The Brain Trauma Foundation has recommended several early indicators of prognosis in severe TBI, including age, hypotension, CT scan features, Glasgow Outcome Scale score, and pupillary diameter with light reflexes. Pupillary diameter and light reflexes have been extensively studied, however accurate measurements of these prognostic factors have not been performed due to a lack of standardized measuring procedure. A new device has been validated to measure both pupil size and reactivity using infrared pupillometry. This device has also been studied to create the Neurological Pupil Index (NPi) as a measure of pupillary reactivity. The NPi has been shown to correlate with intracranial pressure readings, however there are no studies correlating the pupillometer findings with outcome measures in TBI. This study will prospectively evaluate the pupillometer readings of pupillary size and reactivity (NPi) to test the hypothesis that the NPi is a realiable predictor of 30-day outcomes in patients with severe TBI.

NCT ID: NCT02454465 Completed - Stroke Clinical Trials

Evaluation of an Acceptance and Commitment Therapy Group for Adjustment Difficulties in Neurological Conditions

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

With an increase of over 38% in neurological related hospital admissions between 2008-13, there are now over 12.5 million cases of individuals with neurological conditions in the UK. Following diagnosis of a neurological condition, there is often a period of adjustment to new life circumstances, with changes to relationships, ability to work and leisure activities. With a future often fraught with uncertainty, psychological difficulties such as Anxiety and Depression are common. It is estimated that following diagnosis of a neurological condition, up to 60% of individual's will experience mental health difficulties. Acceptance and Commitment Therapy (ACT) has been gaining popularity in supporting those with neurological conditions. ACT is based on emotional acceptance and supporting individuals to live a valued life, despite ongoing symptoms. Research into the use of ACT with this population has found it to be effective in reducing levels of psychological distress and increasing psychological flexibility. With limited resources and an ever increasing desire to improve interventions offered to patients, services are now looking at new and innovative ways of offering increasingly effective and satisfactory treatments. Therefore, in early 2014, the author devised a six week ACT group intervention for adjustment following diagnosis of a neurological condition. The intervention provides a combination of ACT techniques, in addition to a space for group members to build relationships and share their difficulties, to help individuals increase acceptance of their difficulties and reduce psychological distress. Following an initial pilot, findings illustrated that participants' psychological distress reduced and psychological flexibility increased. Therefore, this research project aims to further evaluate the intervention under controlled conditions.

NCT ID: NCT02453958 Completed - Brain Concussion Clinical Trials

Mild Traumatic Brain Injury Discrimination

MTBID
Start date: June 2011
Phase: N/A
Study type: Interventional

Evaluation of the utility of a multi-modal assessment tool in distinguishing between individuals with and without a history of mild traumatic brain injury.

NCT ID: NCT02452619 Enrolling by invitation - Clinical trials for Mild Cognitive Impairment

MRI Brain Changes Induced by Hyperbaric Oxygen Therapy in Brain Injury Patients

Start date: March 2015
Phase: N/A
Study type: Observational

In our institute there is ongoing treatment of brain injury patients with Hyperbaric oxygen therapy. These patients undergo neuro-cognitive function tests in addition to brain imaging studies before and after treatment. The aim of this study was to evaluate the perfusion and microstructure changes seen in MRI in addition to the cognitive tests before and after the treatment.

NCT ID: NCT02452541 Active, not recruiting - Clinical trials for Traumatic Brain Injury

TBI-Prognosis Multicenter Prospective Study

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

Severe traumatic brain injury (TBI) is the leading cause of death and disability among people under 45 years of age and a major public health problem. Although management of severe TBI patients has gradually improved with the establishment of intensive care units (ICU) and the development of practice guidelines, mortality is still high - ranging from 30 to 50% - with 30% of survivors suffering from severe neurological sequelae such as neurovegetative states. Families and medical teams are frequently called upon to determine reasonable and appropriate goals of care for brain injured patients. They may have to consider high intensity of care, but also the withdrawal of life-sustaining therapies in accordance with patient wishes. Physicians involved in the care of severe traumatic brain injury have expressed serious concerns about hasty decisions made in the absence of appropriate evidence of unfavourable prognosis. The purpose of the TBI-Prognosis study is to develop a prognostic model by using a multimodal approach of different prognostic indicators and their evolution over time in the acute phase of care. The results of this study will provide better objective information that will facilitate the shared-decision making-process with families and relatives.