View clinical trials related to Disorder of Consciousness.
Filter by:With the rapid development of life support technology, more and more people can survive severe brain injury. Some survivors regain consciousness after a period of coma, however, many patients develop prolonged disorders of consciousness (DOC), which poses a therapeutic challenge for clinicians and a heavy burden for their families. The investigators design an Electro-acupuncture to treat disorder of consciousness (AcuDoc) trial with the aim of validating the clinical effect of electroacupuncture in treating DOC and exploring its therapeutic mechanisms by integrating EEG, neuroimaging, evoked potential tests, and behavioral assessments.
Early prediction of outcomes after acute brain injury (ABI) remains a major unsolved problem. Presently, physicians make predictions using clinical examination, traditional scoring systems, and statistical models. In this study, we will use a novel technique, "SeeMe," to objectively assess the level of consciousness in patients suffering from comas following ABI. SeeMe is a program that quantifies total facial motion over time and compares the response after a spoken command (i.e. "open your eyes") to a pre-stimulus baseline.
The goal of this observational study is to compare Nociception Coma Scale-Revised Recorded (NCS-R) scores obtained with the standard pressure on fingernail bed (standard stimulus, SS) versus other personalized painful stimuli (PS), in non-communicative patients with disorders of consciousness (DoC), as indicated by professionals and caregivers involved in their care and rehabilitation. The study aims also to establish possible correlations between NCS-R and Coma Recovery Scale-Revised (CRS-R.) The main question : an integrated patient-centered approach for assessment of the physical pain, in which clinical measures and behavioral observations will be integrated, to understand and manage the pain intensity, may improve treatment and rehabilitation outcome. Specifically, a new version of NCS-R, adapted with PS, may produce more intentional and specific responses to pain-inducing maneuvers. Investigating pain perception in non-communicative patients, through recognition of a personalized source of nociception and pain, may avoid non specific, useless and harmful noxious tests (as with standard pain scales) and may provide tools for revealing nociception even in the lack of any response to standard clinical evaluation. Question 1: the superiority of personalized painful stimulus a standard painful stimulation in nin communicative patients. Question 2: the parallel recovery of painful stimuli responsiveness and consciousness Participants will Responsiveness and pain perception will be assessed respectively with the CRS-R and the NCS-R. Pain responses will be assessed by means of standard stimulus (NCS-R-SS, as used in the CRS-R) and personalized stimulation (NCS-R-PS), at admission and discharge. CRS-R will be administered within the first month after admission, at least 5 times in different days, choosing the highest score as reference and repeated during recovery of consciousness or discharge. After informed consent by patient's legal representative or the primary caregiver, for the purpose of the study, caregivers (including relatives, nurses, therapists, physicians) will be asked to record all manoeuvres they feel are associated with potential pain, with a window of observation of the rehabilitation and nursing staff of around one week to identify the personalized painful stimulus (about the second week after admission at the rehabilitation ward). Amongst them, the manoeuvres that consistently over time induced the most motor/behaviour responses suggestive of pain perception, reported at least by 2 members of the rehabilitation staff or by one of them and one caregiver, will be chosen as the personalized stimulus (PS). NCS-R with standard stimulus (NCS-R-SS) and with personalized stimulus (NCS-R-PS), will be recorded within 30 days after admission, alternating the order of the 2 painful stimulations; CRS-R will be recorded accordingly, in parallel to NCS-R-SS and NCS-R-PS and will be blindly recorded, at the same time, by two different rehabilitation staff members, to assess inter-rater reliability, whereas two of them will repeat both NCS-R_SS and NCS-R-PS during the same week to assess intra-rater reliability of both NCS-R-SS and NCS-R-PS, with an interval of at least 6 hours from the last pain killer or anti-spastic drugs administration, including GABAergic, anti-inflammatory drugs or opiates. Both CRS-R and NCS-R (SS and PS) will be repeated 1 month and 3 months after the first assessment with the same procedures of the first time.
The purpose of this study is to determine if the use of emotional sound as subject own name (SON) pronounced by a familiar voice (FV) compared to SON pronounced by a non-familiar voice (NFV) during event related potential (ERP) produced a more reliable neurophysiological P300 responses, and to assess the prognostic value of this P300 responses induced by the SON with a FV.
The coma recovery scale-revised (CRS-R) is the recommended diagnostic scale for consciousness but it requires time, training, and provides total scores that do not always reflect the correct level of consciousness. Recently, a new short-term assessment tool for consciousness assessment has been validated, which could easily be implemented in daily practice to determine the level of consciousness in severely brain injured individuals: the simplified evaluation of consciousness disorders (SECONDs) .Its administration should be significantly shorter than CRS-R and accurate to allow monitoring of consciousness in the subacute / chronic phase. The SECONDs scale was constructed by selecting the items that, based on the latest scientific evidence, are most frequently associated with a minimally consciousness state. In fact, recent studies have shown that 5 items of the CRS-R allow to identify 99% of individuals with minimally consciousness state 1) reproducible movement on command, 2) visual pursuit 3) visual fixation 4) automatic motor response, and 5) localization to pain) 12. In addition, some changes have been introduced such as 1) the assessment of fixation and visual tracking through the use of the mirror 2) the use of autobiographical questions for the assessment of communication 3) the reduction of the number of orders on command to 2 of 3 instead of 3 out of 4 as in the CRS-R. All these changes have been made to minimize time for administration without compromising the accuracy of consciousness detection, to improve feasibility in clinical practice, and also to limit fatigue, which could produce better patient concentration and collaboration. The aim of the multicentre study is to carry out a cross-cultural translation of the SECONDs assessment scale into Italian and to perform a validation between operators of different professions of the Italian version. validation will be conducted on a group of patients with prolunged disorders of consciousness in the subacute phase admitted to two units of severe acquired brain injuries of the don Carlo Gnocchi Foundation of Florence and Sant'Angelo dei Lombardi, and in the chronic phase IRCCS foundation Carlo Besta neurological institute
The goal of this clinical trial is to evaluate the efficacy of a musical interventionand non-invasive brain stimulation in neurological patients. The main questions it aims to answer are: - to evaluate the residual neuroplastic processes in DOC state related to music exposure - to determine the putative modulation of the aforementioned processes and the clinical outcome of DOC patients by non-pharmacological strategies, i.e., electric (tDCS) and music stimulation - to evaluate the impact of this intervention on caregiver's burden and psychological distress. Participants will be randomly assigned to one of three different music-listening intervention groups. Primary outcomes will be clinical, that is based on the neurologist's observations of clinical improvement, and neurophysiological, collected pre-intervention, post-intervention and post-placebo.
The purpose of this study is to elucidate the occurrence of Gamma entrainment and optimize the acousto-optic stimulation parameters to induce it in patients with disorders of consciousness (DOC), to explore the prognostic value of gamma entrainment in patients with DOC, and to clarify the effect of gamma entrainment on the recovery of awareness in DOC patients. This study is divided into three parts. The first and third parts are prospective cohort studies, the second part is a randomized cross control study. We recruit DOC patients, including vegetative state/unresponsive wakefulness syndrome (VS/UWS) or minimally conscious state (MCS). The patients receive sound and light stimulation in the Gamma band, and the changes of EEG are observed simultaneously to explore the occurrence of Gamma entrainment. Meanwhile, the changes of clinical behavior of patients before and after stimulation are evaluated.
Previous studies showed the excitatory effect of cerebellar transcranial magnetic stimulation(TMS) on motor cortex.Investigator evaluate the effects of bilateral cerebellar TMS on Coma Recovery Scale-Revised (CRS-R) scores in patients with disorders of consciousness(DOC) in a randomized, double-blinded, sham-controlled, crossover experimental design.
Introduction: Many patients on intermediate care (IMC) and intensive care units (ICU) suffer from reduced consciousness. In this situation, a treatment attempt with Amantadine is often undertaken. While clinicians report good results with this approach, the treatment is off-label and the scientific evidence limited. Study design: Monocenter, phase IIb, proof of concept, open-label pilot study. Methods: 50 intensive care patients with reduced consciousness not otherwise explained will be treated with Amantadine for 5 days. Vigilance is checked before, during and after treatment (on discharge and after 3 months) using electroencephalography (EEG) and established clinical tests, for instance Glasgow Coma Scale (GCS), Glasgow Outcome Scale - Extended (GOS-E), Coma Recovery Scale Revised (CRS-R) and others. Results: The primary endpoint "improvement of the GCS scale from screening to day 5 of at least 3 points" is analysed according to the Simon design. The secondary endpoints (GCS continuous scale, modified Rankins Scale (mRS), National Institute of Health Stroke Scale (NIHSS), GOS-E, CRS-R and Montreal Cognitive Assessment (MoCA) after 90 days, Richmond Agitation-Sedation Scale (RASS) and Intensive Care Delirium Screening Checklist (ICDSC) will be analysed by mixed models with time (categorically coded) as only factor including all measurements up to 3 months follow up. Discussion: The investigators aim to shed light on an established clinical practice without sufficient scientific evidence. The investigators are aware that the power of our study is limited by design (no control group, no blinding). However, if successful, this study may be the basis for a randomized controlled trial in the future.
Background: The evaluation and treatment of disorders of consciousness(DOC) is a challenging undertaking. Now many neuroimaging techniques were used to detect the level of consciousness and electroencephagram(EEG) was widely used because of its high temporal resolution. Music would be an effective for DOC, due to its highly arousal value. Preferred music was near to persons, so that it would excite more range of cortical and increase the functional connectivity between cortices. Methods: The exploratory study included 15 health controls and 30 DOC, with 15 minimally conscious state(MCS) and 15 vegetative state(VS). After 5 minutes baseline silence, they listened to relaxing music(RM), preferred music(PM) and amplitude modulated sound(AMS), with 5 minutes baseline silence in the end, meanwhile EEG recorded their cortical activity. Each music was appropriately 5 minutes and separated by 3 minutes washout. Discussion: The study would verify the effect of preferred music to the functional connectivity of DOC. Music would excite the networks related to consciousness by cross-modal.