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Brain Injuries clinical trials

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NCT ID: NCT02696512 Recruiting - Brain Injury Clinical Trials

A Study of IBRF Disorders of Consciousness Advanced Care/MultiModal Care Protocol in Severe Disorders of Consciousness

Start date: March 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This is a study to evaluate the safety and efficacy of the IBRF ACP/MCP intervention protocol in patients with severe disorders of consciousness (SDOC).

NCT ID: NCT02644265 Recruiting - Clinical trials for Consciousness Disorders

CONNECT-ME: Consciousness in Neurocritical Care Cohort Study Using fMRI and EEG

CONNECT-ME
Start date: April 12, 2017
Phase:
Study type: Observational [Patient Registry]

Detecting preserved consciousness in brain-injured patients by traditional clinical means requires presence of motor function. Otherwise, patients may be erroneously classified as being in a vegetative state. In order to circumvent the need for motor function, paradigms using functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) have been developed. According to a recent meta-analysis, 15% of patients with a clinical diagnosis of vegetative state can follow commands by performing mental imaginary tasks, strongly suggesting they are indeed conscious. This is of utmost importance for prognosis, treatment, and resource allocation. However, consciousness paradigms are usually employed in rehabilitation medicine. Therefore, opportunities to optimize patient outcome at an early stage may be lost. As a novel approach, the CONsciousness in NEurocritical Care cohorT study using fMRI and EEG (CONNECT-ME) will import the full range of consciousness paradigms into neurocritical care. The investigators aim to assess patients with acute brain injury for preserved consciousness by serial multimodal evaluations using active, passive and resting state fMRI- and EEG-based paradigms. A prospective longitudinal database and a biobank for genomic and metabolomic research will be established. This approach will add essential clinical information, including detection of preserved consciousness in patients previously thought of as unconscious. Due to its complexity, this project is divided into nine work packages. Eventually, the investigators will have established a clinical service for the systematic assessment of covert consciousness, as well as an interdisciplinary research group dedicated to the neuronal mechanisms by which consciousness recovers after acute brain injury.

NCT ID: NCT02637817 Recruiting - Cerebral Palsy Clinical Trials

MRI-based Biomarkers for Predicting Punctate White Matter Lesions in Neonates

PWML
Start date: January 2016
Phase:
Study type: Observational

As a common white matter (WM) disease in preterm neonates, punctate white matter lesion (PWML) frequently leads to the abnormalities of brain development (e.g. the motor, visual and auditory disorders), even to cerebral palsy (CP) and amblyopia during childhood. However, it is lack of certain methods in identifying the prognosis of PWML. Through using various advanced MRI techniques, neuro-behavioral and visual assessments, a multicenter longitudinal study would be conducted to follow-up the PWML neonates with varying spatial-position and degree lesions. Through tracking the variations in WM microstructures from neonate period to childhood (2 years old and 3 years old), this study aims to explore (1) the potential relations between varying PWMLs and motor and visual disorders (2) the relations between WM MRI-metrics and neurodevelopmental assessment results, and thus determine the early biomarkers to identify CP and amblyopia.

NCT ID: NCT02592291 Recruiting - Cerebral Palsy Clinical Trials

Mobile Health Self-Management and Support System for Chronic and Complex Health Conditions

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

This study will assess the benefits of using mobile health system designed for individuals with chronic and complex health conditions (such as those with Spinal Cord Injury,Cerebral Palsy, Spina Bifida, and Traumatic Brain Injury) to improve their wellness and self-management skills compared to those who receive standard of care only.

NCT ID: NCT02574169 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome (ARDS)

Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation

M'RHICO
Start date: September 1, 2016
Phase: N/A
Study type: Interventional

This study aims to compare 2 alveolar recruitment maneuvers (ARM) in patients with cerebral injuries and acute respiratory distress syndrome (ARDS) in term of efficacy and tolerance.

NCT ID: NCT02567201 Recruiting - Brain Injury Clinical Trials

Electrophysiological Evaluation of Voluntary Attention

EVA
Start date: October 16, 2015
Phase: N/A
Study type: Interventional

Aim : To assess the ability of healthy subjects and patients with a severe motor disability to voluntary control their attention Material and Methods: Population: healthy subjects, patients with brain injury Electroencephalographic study to research attentional modulation during different kind of stimulation (visual, auditory, tactile) Sudy 1: passive recording. Study 2: active recording (instruction of attentional control given to the subject). Study 3: active recording with a feedback obtained after a processing of the brain activity.

NCT ID: NCT02536079 Recruiting - Brain Injury Clinical Trials

NeuroAiD Safe Treatment Registry

NeST
Start date: June 2014
Phase:
Study type: Observational [Patient Registry]

The NeST registry is a pro-active industry-academic collaboration to assess the use and safety of NeuroAiD in the real world setting. An online entry system was set up to allow easy data entry and retrieval of clinical information.

NCT ID: NCT02499133 Recruiting - Focused Stress Clinical Trials

Identification and Comprehension of Focused Stress in a Sentence Among Adults Who Suffered Traumatic Brain Injury

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

Researches that focus on the perception of prosodic elements among adult who suffered traumatic brain injury (TBI), focus on their ability to decipher intonation in order to understand an additional meaning of a sentence. According to these researches, adults who suffer from TBI, with no signs of Aphasia, have difficulty perceiving and deciphering intonation (Marquardt et al., 2001; Angeleri et al., 2008). The current research asks to broaden the knowledge in this domain by examining the ability of adults with TBI to understand an additional prosodic element - focused stress. The ability to identify and understand focused stress in a sentence requires different abilities. First, a psychoacoustic ability in order to detect the stressed word. Second, an ability to understand the lexical grammatical meaning of the word as it negates other possible meanings (for example, in the sentence "I'm eating a red apple" the stressed word negated the option of a different color). Third, an understanding of the stressed word as it creates a different pragmatic/social meaning (for example, in the sentence "mom, I asked for red, yellow and green candy" the role of the stressed word is to mark the candy that the addressee didn't get). The aim of the study is to assess the ability of adults who had experienced TBI to grasp and understand the meaning of focused stress in the different contexts that were described above. An additional aim is to examine if differences in speech and cognitive abilities can describe some of the variation in the results. Thirty adults between the ages of 18-50 years will take part in this study, fifteen adults who had experienced moderate to severe TBI (0.5-3 years post injury) and fifteen healthy adults. Each participant with TBI will be matched to a healthy adult by gender, age, education and social-economic status. All of the participants will be Hebrew native speakers, with no learning disability, no neurological injury, proper speech abilities and no hearing impairment. The participants will undergo seven different tests in three different meetings (60 minute each), in a quiet room at Sheba - Academic Medical Center Hospital. The tests will include different cognitive and language examinations. The main test of the study will be The Hebrew Focused Stress Test (HFST). The HFST includes three subtests. The first subtest requires identification of the stressed word in a sentence based on psychoacoustic abilities alone. The second and the third subtests require understanding the meaning of focused stress in different contexts - lexical grammatical and pragmatic/social. The test includes forty eight recorded sentences. In each sentence one word is stressed. The participants will be asked to listen to the recordings and answer a closed question regarding the stressed word.

NCT ID: NCT02495558 Recruiting - Pneumonia Clinical Trials

Cough Assessment in Patients With Severe Acquired Brain Injury

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

The cough assessment is fundamental in the weaning process as it gives information on the possibility to expel food and secretion out from the airways. The majority of persons suffering from severe acquired brain injury are not able to cough voluntary due to severe cognitive deficit. In the present study, it would be evaluated the intensity of the reflex cough (RC) and the results would be correlated with weaning outcome.

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?