View clinical trials related to Disorder of Consciousness.
Filter by:Prolonged Disorders Of Consciousness (PDOC) include the Vegetative State (VS) and the Minimally Conscious State (MCS) that persist for longer than four weeks. This research seeks to evaluate the validity (accuracy), reliability, and clinical utility (usefulness to clinicians) of the children's version of the Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC). The paediatric version is called the Music therapy Sensory Instrument for Cognition, Consciousness and Awareness (MuSICCA). The MATADOC is known to be accurate in diagnosis and has been shown to be clinically useful when working with adults. However, currently, there are no equivalent measures that have been rigorously tested for working with children. Therefore, there is a significant need for a valid and reliable measure, especially when the consequences of misdiagnosis include insufficient care provision, unsuitable treatment programmes, poor identification of intentions to communicate, and insufficient evidence for making difficult decisions around withdrawal of hydration and nutrition. The study will invite participants aged 2-18 years, who the medical team suspect of having a PDOC, from various medical facilities in the UK, Ireland and other English-speaking countries. Parental/carer consent will be required for inclusion in the study. Data collection will occur over 3 years. Each participant will be involved once for a maximum of 7 assessment sessions (4 for the MuSICCA, 1 for the Coma Recovery Scale - Revised (CRS-R), 1 for the Coma/Near Coma Scale (CNC), and 1 for the Nociception Coma Scale Revised (NCS-R)). The MuSICCA assessment protocol involves presenting musical stimuli in three modalities (visual, auditory, and tactile). The participants will be instructed to respond to stimuli and commands. Sessions will be recorded using audio-visual equipment and physical responses will be noted on documentation. The information gained will inform diagnosis and treatment. The participants' behaviours will also be scored on the CRS-R (the gold standard for diagnosis of DOC in adults), the CNC and the NCS-R.
Disorders of consciousness(DOC) is the most serious complications and has been widely paid attention to by the government. DOC patients cause large social and economic burden to our society for there has no effective cure so far. Spinal cord stimulation(SCS) for wake-promoting therapy has aroused scholars' attention and become a hot area recently. There was much debate about the effectiveness of SCS therapy, but because of the limitation of our understanding of consciousness and the uncertainty of parameters of the stimulation, So, to figure out the indications and effectiveness of neuromodulation therapy should be the first step, and finding individual treatment and parameter may have important implications for DOC patients.
STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases a person can be left in a state where they are "awake" but unaware, which is called unresponsive wakefulness syndrome (UWS, previously known as a vegetative state). Up to 43% of patients with a UWS diagnosis, regain some conscious awareness, and are then reclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimally conscious state (MCS) and all with unresponsive wakefulness syndrome (UWS) are incapable of providing any, or consistent, overt motor responses and therefore, in some cases, existing measures of consciousness are not able to provide an accurate assessment. Furthermore, patients with locked-in syndrome (LIS), which is not a disorder of consciousness as patients are wholly aware, also, struggle to produce overt motor responses due to paralysis and anarthria, leading to long delays in accurate diagnoses using current measures to determine levels of consciousness and awareness. There is evidence that LIS patients, and a subset of patients with prolonged disorders of consciousness (DoC), can imagine movement (such as imagining lifting a heavy weight with their right arm) when given instructions presented either auditorily or visually - and the pattern of brain activity that they produce when imagining these movements, can be recorded using a method known as electroencephalography (or EEG). With these findings, the investigators have gathered evidence that EEG-based bedside detection of conscious awareness is possible using Brain- Computer Interface (BCI) technology - whereby a computer programme translates information from the users EEG-recorded patterns of activity, to computer commands that allow the user to interact via a user interface. The BCI system for the current study employs three possible imagined movement combinations for a two-class movement classification; left- vs right-arm, right-arm vs feet, and left-arm vs feet. Participants are trained, using real-time feedback on their performance, to use one of these combinations of imagined movement to respond to 'yes' or 'no' answer questions in the Q&A sessions, by imagining one movement for 'yes' and the other for 'no'. A single combination of movements is chosen for each participant at the outset, and this participant-specific combination is used throughout their sessions. The study comprises three phases. The assessment Phase I (sessions 1-2) is to determine if the patient can imagine movements and produce detectable modulation in sensorimotor rhythms and thus is responding to instructions. Phase II (sessions 3-6) involves motor-imagery (MI) -BCI training with neurofeedback to facilitate learning of brain activity modulation; Phase III (sessions 7-10) assesses patients' MI-BCI response to closed questions, categorized to assess biographical, numerical, logical, and situational awareness. The present study augments the evidence of the efficacy for EEG-based BCI technology as an objective movement-independent diagnostic tool for the assessment of, and distinction between, PDoC and LIS patients.
Following severe traumatic brain injury, patients may remain unconscious for many years. It is the first proteomic analysis comparing differentially expressed proteins between patients with chronic disorder of consciousness and controls so far. The investigators generated accurate lists of proteomes and identified differences at different disease time courses. The obtained results provide new insight into understanding the molecular mechanisms underlying the chronic disorder of consciousness.
The aim of this study is to investigate the effect of transcranial Alternating Current Stimulation (tACS) at theta frequency and the the effect of transcranial Direct Current Stimulation (tDCS) on the conscious state of non-communicating patients. tACS and tDCS are non-invasive stimulation techniques that are used to induce brain oscillations at certain frequency or to increase the brain activity in applied region. Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some Minimally Conscious State (MCS) patients, and in some Vegetative State (VS) patients. However the optimal intensity of electrical current stimulation remains unknown and transcranial Alternative Current Stimulation (tACS), with the ability to stimulate cortex at specific frequencies and to manipulate phase-synchrony between regions is a promising techniques to improve patients' consciousness. In this study, the investigators will use prefrontal tDCS and theta tACS to improve patients consciousness level.
The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings. One limitation of the CRS-R is the lengthy administration time required to obtain a total score. Administration time can vary from approximately 15-30 minutes, depending on the patient's level of responsiveness. For this reason, the CRS-R is rarely administered in the acute hospital setting. Less time-consuming scales and metrics are used to assess conscious awareness in the acute hospital/ICU setting, but they lack specificity and sensitivity and have not been validated, increasing the potential for misdiagnosis. In conjunction with the developers of the Neuroscore (an unpublished, abbreviated version of the CRS-R), we have developed the CRSR-FAST and aim to test its validity, inter- and intra- rater reliability. We anticipate that, compared with the CRS-R, the CRSR-FAST will be less time-consuming to administer and score, but will maintain a high level of sensitivity to detecting signs of consciousness in severely brain injured patients.
Transcranial magnetic stimulation involves the use of alternating magnetic fields to stimulate neurons in the brain.To date, several studies have focused on the use of TMS in patients with impaired consciousness.However,its therapeutic effects have been variously documented.So,in this study ,investigators explore the effects of rTMS with cross-over design.
Limited treatments are available to improve consciousness in severely brain injured patients. Transcranial Direct Current stimulation (tDCS) is one of the few therapeutics that showed evidence of efficacy to increase level of consciousness and functional communication in some minimally conscious state (MCS) patients, and in some vegetative state (VS) patients. However the optimal intensity of electrical current stimulation remains unknown. This study will test the effects of two intensities of tDCS stimulation (either 0.2mA or 2mA) applied on left dorso-lateral prefrontal cortex on both behavior, - assessed by the Coma Recovery Scale-Revised (CRS-R) scores -, as well as quantified EEG recorded during resting state (using algorithms previously designed and published by the investigators) and event-related potentials (using auditory paradigms we previously published) in severely brain damaged patients with disorders of consciousness (MCS, VS, and conscious but cognitively disabled patients) of various etiologies.