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Consciousness Disorders clinical trials

View clinical trials related to Consciousness Disorders.

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NCT ID: NCT02930213 Completed - Clinical trials for Disorders of Consciousness

The Core Body Temperature Rhythms: Distinguishing MCS From UWS

Start date: January 2015
Phase: Phase 2
Study type: Observational [Patient Registry]

In this study, the core body temperature of 7 disorders of consciousness ( DOC ) patients were measured every 2 hour for 168 h .

NCT ID: NCT02879565 Completed - Clinical trials for Disorders of Consciousness

Families Expectations and Hope Raised by an Evaluation of Consciousness in Patients in a Vegetative State

REVE
Start date: September 2011
Phase: N/A
Study type: Interventional

Progress in resuscitation has increased the chances of survival after anoxic or traumatic brain injury. More and more patients with severe cerebral damages are resuscitated but upon awakening from coma, some patients remain in a state which cannot be qualified as conscious and is now known as an unresponsive wakefulness syndrome (UWS; formerly known as vegetative state). This condition can be transitory and evolve towards recovery, or remain chronic and lasting for years. To improve the diagnosis of patients with disorders of consciousness, recent advances in brain imaging have led to the development of new methods of detecting awareness. In the absence of overt behavioral responses from these patients, imaging-based diagnostic methods have been first used to assess whether some cerebral areas were preserved in UWS patients and showed an activation of the primary sensory cortices in some UWS patients, whether it occurs at the auditory, visual or somatosensory level. Unavoidable technical and ethical issues are raised for clinicians before responding to such requests: 1. Is it technically possible to generalize neuroimaging protocols to all healthcare institutions? 2. Is it ethically acceptable to propose neuroimaging protocols without an accurate estimation of their psychological impact on families and caregivers? The present study aims to understand and anticipate the technical and ethical issues related to an evaluation of consciousness with functional neuroimaging. How the evaluation of awareness in a patient affects the caregivers and family members will be investigated. By using qualitative research hopes and expectations will be clarified through the experiences of families, clinicians and nurses faced to this situation. Will be included in this research professional caregivers and persons closely related to UWS patients: - Family members or close circle visiting the patients on a regular basis - Referring clinicians - Nurses in charge of the patients' care This prospective study uses qualitative, interview-based, research. Two key-moments are explored in succession to examine the impact of a neuroimaging evaluation of consciousness in institutionalized UWS patients: - interviews of professional caregivers and families about their hopes concerning the evaluation of consciousness of UWS patients, - interviews of professional caregivers and families about the impact of evaluating consciousness on their beliefs

NCT ID: NCT02828371 Completed - Brain Injury Clinical Trials

Early Stepping Verticalization in ICU for ABI Patients

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

Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. The investigators evaluated the effectiveness of a very early stepping verticalization protocol on the functional and neurological outcome of patients affected by disorder of consciousness due to ABI. Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to a Neurorehabilitation unit for an individualized treatment. Outcome measures were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2).

NCT ID: NCT02772302 Completed - Clinical trials for Consciousness Disorders

Feasibility of mindBEAGLE in Disorders of Consciousness or Locked-In Syndrome

Start date: March 1, 2016
Phase: N/A
Study type: Interventional

The primary aims of this study are: 1. To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome (LIS); 2. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness; 3. To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness; 4. To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.

NCT ID: NCT02760446 Completed - Clinical trials for Patients With Mental Confusion

Translation and Validation of the French Version of Confusion Assessment Method for the Intensive Care Unit

CAM-ICU
Start date: November 2015
Phase: N/A
Study type: Interventional

Validity and Reliability of French Version of the Confusion Assessment Method for the Intensive Care Unit (psychometric validation study after translation/back translation process assessed by the original team : W.Ely, MD, Ph.D, Vanderbilt University)

NCT ID: NCT02759068 Completed - Clinical trials for Disorders of Consciousness

Beneficial Effects of Preference on Behavior in DOC Patients (COGNICOMA)

COGNICOMA
Start date: November 2014
Phase: N/A
Study type: Interventional

Preferred music improves cognitive function in patients with disorders of consciousness (DOC). However, it is still unknown whether it is a general effect of music (because of its acoustic features) or an autobiographical effect (because of its emotional and meaningful contents). The aim of the present study was to investigate the effect of sensory modality (auditory versus olfactory) and preference (preferred versus neutral) of the testing context on the performance of four items from the coma recovery scale-revised

NCT ID: NCT02732288 Terminated - Clinical trials for Disorders of Consciousness

Exploratory Study of Melatonin Induced Sleep Regularization in Severe Brain Injury

Start date: May 2016
Phase: N/A
Study type: Interventional

Patients with severe brain injuries often have slow accumulating recoveries of function. In ongoing studies, we have discovered that elements of electrical activity during sleep may correlate with the level of behavioral recovery observed in patients. It is unknown whether such changes are causally linked to behavioral recovery. Sleep processes are, however, associated with several critical processes supporting the cellular integrity of neurons and neuronal mechanisms associated with learning and synaptic modifications. These known associations suggest the possibility that targeting the normalization of brain electrical activity during sleep may aid the recovery process. A well-studied mechanism organizing the pattern of electrical activity that characterizes sleep is the body's release of the substance melatonin. Melatonin is produced in the brain and released at a precise time during the day (normally around 8-10PM) to signal the brain to initiate aspects of the sleep process each day. Ongoing research by other scientists has demonstrated that providing a small dose of melatonin can improve the regular pattern of sleep and help aid sleep induction. Melatonin use has been shown to be effective in the treatment of time change effects on sleep ("jet lag") and mood disturbances associated with changes in daily light cues such as seasonal affective disorder. We propose to study the effects of melatonin administration in patients with severe structural brain injuries and disorders of consciousness. We will measure the patient's own timing of release of melatonin and provide a dose of melatonin at night to test the effects on the electrical activity of sleep over a three month period. In addition to brain electrical activity we will record sleep behavioral data and physical activity using activity monitors worn by the patients. Patient subjects in this study will be studied twice during the three month period in three day inpatient visits where they will undergo video monitoring and sampling of brain electrical activity using pasted electrodes ("EEG"), hourly saliva sampling for one day, and participation in behavioral testing.

NCT ID: NCT02714491 Recruiting - Clinical trials for Consciousness Disorders

Effects of Auditory Stimulation During Verticalization With Erigo in Patients With Disorder of Consciousness

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

Aim of the study is to define if the auditory stimulation during stepping verticalization sessions with "Erigo" is able to modify the cerebral electric activity or improve consciousness in patients affected by vegetative state or minimally conscious state.

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: NCT02667899 Recruiting - Clinical trials for Consciousness Disorders

The Consciousness Variation of Deep Brain and Transcranial Magnetic Stimulation for Disorders of Consciousness Patients

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

Aims:To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS (Transcranial Magnetic Simulation) for DOC (Disorders of Consciousness) patients. Methods:Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group and Control group. Three months after treatments, the result will be analysed and concluded.