Active clinical trials for "Consciousness Disorders"

The purpose of this study was to determine the effect of stroke on post-stroke level of consciousness through a double-blind, placebo-controlled, randomized study design. And Brain 18F-FDG PET was used to reveal the mechanism of recovery after cerebrolysin administration. Thirty patients with chronic stroke patients with minimal consciousness (MCS) or vegetative human (VS) level of consciousness disorder in the revised coma recovery scale were enrolled. Thirty patients were randomly divided into a Cerebrolysin group and a placebo group.

Low-intensity focused ultrasound can be effective in severe TBI patients with disorder of consciousness. This study is a prospective single arm, open-label and explorative clinical trial to evaluate the therapeutic effect of recovery from DoC and safety of low-intensity focused ultrasound stimulation at thalamic area in patients with post-traumatic DoC.

Background: Disorder of consciousness(DOC) is a series of arousal and cognitive disorders secondary to the most severe brain injury. Once a patient is diagnosed with a DOC, a poor prognosis is assumed and the rehabilitation for whom is greatly limited. Therefore, the treatment of DOC poses extraordinary challenges. Various treatments protocols have been reported of successful in promoting rehabilitation of DOC patients. Repetitive transcranial magnetic stimulation(rTMS), as a non-invasive brain stimulation technique, has shown potentials for consciousness rehabilitation of DOC patients as it is effective in regulating the central nervous system. Methods and design: This protocol is a double-blind randomized sham-controlled crossover trial. Totally 30 participants will be randomly assigned to either group 1 or group 2 in a 1:1 ratio, with 15 patients in each group. Each patient will received 20 sessions, in which 10 sessions will be active and 10 will be sham, separated by 10-days washout period. The active-rTMS will include 10 Hz rTMS over the individual-targeted area on each participants. Primary and secondary evaluating indicators will be performed at each baseline and after rTMS treatment. Primary outcome will be determined as behavioral response to treatment as measured using the Coma Recovery Scale - Revised (CRS-R). Resting-state high-density EEG will be also recorded to investigate the neurophysiological correlates by rTMS. Discussion:This study will contribute to define the role of rTMS for the treatment of DOC patients and characterise the neural correlates of its action. The investigators proposed a method of individualized target selection for DOC patients based on the existing gold standard CRS-R score and MRI, and used a cross randomized controlled trial to verify the role of rTMS in DOC treatment.

In this preliminary study, we will examine the safety, tolerability, and feasibility of transcranial direct current stimulation (tDCS), in the setting of dosage escalation, as a candidate intervention for children with Acquired Brain Injury (ABI).

It is known that even in patients with severe disorders of consciousness (DOC), the perception of known stimuli triggers emotional reactions that can be interpreted as an expression of a residual function of consciousness. Music therapy has a long tradition in neurological rehabilitation. Frequently, active therapies with own music making and singing are implemented in clinical settings. In DOC patients, it is more likely to use passive music listening. However, findings on effectiveness are limited, as only a few studies have systematically investigated the effects of music therapy in this population. Therefore, the investigators want to investigate the effectiveness of passive listening to preferred music on the level of consciousness.

The research focuses on establishing a system for validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness.

After acute brain injury or haemorrhagic stroke, hydrocephalus might participate to consciousness disorder. We plan to explore whether ventriculoperitoneal shunt insertion improves consciousness in patients with vegetative or minimally conscious state and hydrocephalus. Patients with acute brain injury, persistent consciousness disorder and hydrocephalus will be shunted with a detailed follow-up at 3 months combining: clinical evaluation, FluoroDésoxyGlucose positron emission tomography imaging, high density electroencephalogram, electrocardiogram Holter and sympathetic activity by microneurography.

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.

The aim of the presented study is to examine the effectiveness of sensory stimulation in reducing pain and stress of patients diagnosed with Disorder of consciousness.

Disorder of consciousness (DoC) is a state in which consciousness is altered because of brain damage and can occur under a variety of conditions: in fact, the most frequent causes of DoC are vascular disease, head trauma, and cerebral hypoxia. DoCs result from the loss of regulation of neural function of the two components of consciousness, alertness and awareness. Depending on the patient's behavior and responsiveness, DoCs can be identified in different states, from coma to persistent vegetative state (VS) to intermittent minimally conscious state (MCS). Regarding the prognosis of recovery, in patients with DoC the chance of having functional improvement decreases with time, although some positive functional changes have been observed in chronic patients. Therapies for DoC include some drugs, such as dopaminergic, GABAergic and amantadine drugs, which work to facilitate the recovery of consciousness. Neurorehabilitation, however, seems to be the most recognized intervention that aims to strengthen, in uninjured brain regions, the spontaneous neuroplasticity that occurs to compensate for lost function. Simultaneous stimulation of multiple senses, such as hearing, sight and smell, provides the neural network with more stimuli that are more effective than a single stimulus. In fact, multisensory stimuli can more easily activate attention because cortical processing is predominantly multimodal. As for content, it would seem that those with autobiographical and emotionally salient character could engage multiple brain networks and have priority access to attention. Numerous trials show that stimulus-containing content led to increased behavioural activity, improving self-awareness in patients with DoC. Considering that a communication system that can combine both visual and auditory channels proves to be more effective than a "single-sense" channel, multisensory stimulation is likely to provide simultaneous activation of different brain areas by enhancing plasticity processes. Furthermore, the intensity of stimulation could be one of the main variables with greater impact on the patient: in fact, higher intensity would correspond to a greater effect on the brain.