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Vegetative State clinical trials

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NCT ID: NCT03826407 Active, not recruiting - Clinical trials for Disorder of Consciousness

Development of a Point of Care System for Automated Coma Prognosis

Start date: October 1, 2019
Phase:
Study type: Observational

Electroencephalogram/event-related potentials (EEG/ERP) data will be collected from 50 participants in coma or other disorder of consciousness (DOC; i.e., Unresponsive Wakefulness Syndrome [UWS] or Minimally Conscious State [MCS]), clinically diagnosed using the Glasgow Coma Scale (GCS). For coma patients, EEG recordings will be conducted for up to 24 consecutive hours at a maximum of 5 timepoints, spanning 30 days from the date of recruitment, to track participants' clinical state. For DOC patients, there will be an initial EEG recording up to 24 hours, with possible subsequent weekly recordings up to 2 hours. An additional dataset from 40 healthy controls will be collected, each spanning up to a 12-hour recording period in order to formulate a baseline. Collected data are to form the basis for automatic analysis and detection of ERP components in DOC, using a machine learning paradigm. Salient features (i.e., biomarkers) extracted from the ERPs and resting-state EEG will be identified and combined in an optimal fashion to give an accurate indicator of prognosis.

NCT ID: NCT03823508 Completed - Clinical trials for Disorder of Consciousness

Prefontal tDCS in Patients With Disorders of Consciousness: Neurophysiological and Behavioural Outcomes

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Non-invasive brain stimulations techniques have recently shown promising results in patients with disorders. Notably, transcranial direct current stimulation (tDCS) applied over the left dorsolateral prefrontal cortex has proved to be effective in improving signs of consciousness in about 50% of patients in MCS either after a single stimulation or after repeated sessions. However, brain mechanisms underlying tDCS effects remain poorly understood. Here we aim to assess the effects of prefrontal tDCS on neurophysiological (i.e., electroencephalography - EEG - primary outcome) and behavioral (secondary outcome) measures in severely brain-injured patients with DOC.

NCT ID: NCT03797573 Completed - Spasticity, Muscle Clinical Trials

Multichannel tDCS to Reduce Hypertonia in Patients With Prolonged DOC

Start date: January 20, 2014
Phase: Phase 1
Study type: Interventional

Previous studies showed that transcranial direct current stimulation (tDCS) transiently improves performance of motor function in stroke patients, as well as decrease muscle hypertonia. In severely brain injured patients with disorders of consciousness (DOC), a single stimulation over the left dorsolateral prefrontal cortex has shown to improve patients' sign of consciousness. Nevertheless, other brain areas could be stimulated in order to manage other symptoms occurring in this population of patients, such as muscle hypertonia. In this study, investigators will assess the effects of bilateral fronto-central tDCS on spasticity as measured with the Modified Ashworth Scale (MAS) and on the Coma Recovery Scale-Revised (CRS-R) scores in patients with DOC in a double-blind sham-controlled experimental design.

NCT ID: NCT03732092 Completed - Clinical trials for Minimally Conscious State

The Effects of Olfactory Stimulation on Diagnosis and Prognosis of DOC Patients

Start date: March 15, 2018
Phase:
Study type: Observational

Analyze the behavioral response of patients with disorders of consciousness through olfactory stimulation, compare the response of olfactory stimulation in patients with different consciousness, and analyze the impact of olfactory stimulation on diagnosis; After the first, third, and sixth months of initial enrollment, the recovery of prognosis was tracked by the Coma Recovery Scale-Revision (CRS-R).

NCT ID: NCT03508336 Completed - Clinical trials for Minimally Conscious State

The Initiation of Swallowing Can Indicate the Prognosis of DOC

Start date: June 3, 2016
Phase:
Study type: Observational

This study is aimed to detect the initiation of swallowing act in DOC patients, to find if it is a good item as a stimulus and to detect the relationship between the initiation of swallowing act and the prognosis of DOC patients.

NCT ID: NCT03494218 Completed - Clinical trials for Minimally Conscious State

Reliability and Validity of the NCS (NCS-R)-Chinese Version

Start date: October 28, 2017
Phase: N/A
Study type: Interventional

The aim of this study was to translate the NCS from English into Chinese and determine the validity of this Chinese version.

NCT ID: NCT03492294 Completed - Clinical trials for Minimally Conscious State

The Role of Music Stimulation in Disorders of Consciousness State: an fMRI Study

Start date: December 2008
Phase:
Study type: Observational

The aim of the present study was to evaluated the neural effect of music on the cerebral activation in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) by using functional magnetic resonance imaging (fMRI).

NCT ID: NCT03367078 Terminated - Clinical trials for Cognitive Impairment

tDCS in Patients With Disorder of Consciousness Due to Severe Acquired Brain Injury

Start date: June 18, 2018
Phase:
Study type: Observational

The present observational study is aimed at reporting the short-, mid- and long-term outcomes of patients with Disorder of Consciousness (DOC), in Vegetative State (VS) or Minimally Conscious State (MCS), due to a severe Acquired Brain Injury (sABI), after repeated treatments with anodal Transcranial Direct Current Stimulation (tDCS) on Left Dorsolateral Prefrontal Cortex (L-DLPFC), to stimulate recovery of consciousness. The results obtained will also be compared with those of a historical control cohort, before the introduction of tDCS, matched for demographic and clinical characteristics.

NCT ID: NCT03126929 Completed - Clinical trials for Minimally Conscious State

Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R

Start date: March 2012
Phase: N/A
Study type: Observational

This study aims to provide, in a large sample, further psychometric data as regards the internal consistency, the test-retest reliability and the diagnostic validity of the Coma Recovery Scale-Revised (CRS-R).

NCT ID: NCT03007784 Recruiting - Clinical trials for Cognitive Impairment

Two Intensities of Transcranial Direct Current Stimulation to Improve Consciousness in Severely Brain Injured Patients

STIMCOM
Start date: January 2017
Phase: Phase 3
Study type: Interventional

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.