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Persistent Vegetative State clinical trials

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NCT ID: NCT02566720 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study

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

This is a pilot study. The objective is to further understand the mechanism by which amantadine improves function in patients with persistent vegetative state and minimally conscious state. Specifically, the investigators will measure the size of the nerve fibers that mediate arousal (reticular activating system, or RAS) pre and post treatment on MRI tractography. MRI findings will be correlated with the Disability Rating Scale (DRS) score. The information gathered from this study will be used to formulate a larger clinical trial.

NCT ID: NCT02288533 Completed - TBI Clinical Trials

Transcranial Direct Current Stimulation Effects in Patients With Chronic Consciousness Disorders

Start date: September 2014
Phase: N/A
Study type: Interventional

Chronic consciousness disorders have high level of impact on public health and its costs.

NCT ID: NCT02019615 Completed - Clinical trials for Patients in Minimally Conscious State After a Severe Brain Injury (e.g., Anoxia, Traumatic Brain Injury, Stroke)

tDCS in MCS: Repeated Stimulations

tDCS in MCS
Start date: February 2013
Phase: N/A
Study type: Interventional

In this study researchers will apply transcranial direct current stimulation (tDCS) for 5 consecutive days in chronic patients in minimally conscious state (MCS). 2 sessions of 5 days of stimulation will be realized, one anodal and one sham. After each stimulation, behavioral improvement will be assessed with the Coma Recovery Scale Revised (CRS-R). A final assessment will be done one week after the end of the sessions to assess the long term effect of the tDCS.

NCT ID: NCT01820923 Completed - Clinical trials for Minimally Conscious State

Transcranial Brain Stimulation in Vegetative State Patients

Start date: July 2011
Phase: N/A
Study type: Interventional

The aim of this study is to determine whether transcranial brain stimulations, such as repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS), are effective in terms of EEG coherence and clinical changes in patients in vegetative and minimally conscious state.

NCT ID: NCT01718249 Completed - Clinical trials for Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)

Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness

Post-coma DBS
Start date: April 2012
Phase: N/A
Study type: Interventional

Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this protocol is to study the effects of deep brain stimulation on conscious behavior, using a patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised (CRS-R) as clinical assessment criterion.

NCT ID: NCT01673126 Completed - Clinical trials for Minimally Conscious State

Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness

tDCS in DOC
Start date: January 2010
Phase: Phase 2
Study type: Interventional

Previous studies showed that anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal (DLPF) cortex transiently improves performance of memory and attention. Investigator assessed the effects of left DLPF-tDCS on Coma Recovery Scale-Revised (CRS-R) scores in severely brain damaged patients with disorders of consciousness in a double-blind sham-controlled experimental design.

NCT ID: NCT01467908 Completed - Stroke Clinical Trials

Navigated Brain Stimulation in Diagnosis of Minimally Conscious State

C-fMRI-NBS
Start date: June 2011
Phase: N/A
Study type: Interventional

It has already been demonstrated that mental imagining of the complex motor act, such as limb lifting, can evoke the activation of the involved motor centres even if it doesn't result in movement due to paresis. Aim of the study: using the navigated brain stimulation system create a new diagnostic model for the differential diagnostics between the vegetative state and the minimally conscious state. If the investigators could get from patient the efferent motor response after a verbal command, his level of conscious should not be defined less than the minimally conscious state.

NCT ID: NCT01438684 Suspended - Clinical trials for Chronic Vegetative State

The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study

RPh-in-CVS
Start date: September 2012
Phase: Phase 1
Study type: Interventional

The aim is to evaluate the impact of RPh201 on brain activity in chronic vegetative state patients. The assessment will be done using clinical measurements and functional MRI studies.

NCT ID: NCT01417299 Withdrawn - Clinical trials for Chronic Vegetative State

The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements

CVS
Start date: October 2011
Phase: Phase 1/Phase 2
Study type: Interventional

The investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201 has been reported to induce neuronal regeneration in animal models. Evaluation will be done by combining clinical /behavioral assessment with fMRI studies.

NCT ID: NCT01260090 Withdrawn - Clinical trials for Persistently Vegetative States Due to Traumatic Brain Injury

Vagus Nerve Stimulation to Augment Recovery From Minimally Conscious or Persistently Vegetative States After Traumatic Brain Injury

Start date: January 2011
Phase: Phase 2/Phase 3
Study type: Interventional

Traumatic brain injury has a high morbidity and mortality in both civilian and military populations. Blast and other mechanisms of traumatic brain injury damage the brain by causing neurons to disconnect and atrophy. Such traumatic axonal injury can lead to persistently vegetative and minimally conscious states, for which extremely limited treatment options exist, including physical, occupational, speech and cognitive therapies. More than 50,000 patients have received vagus nerve stimulation for epilepsy and depression. In addition to decreased seizure frequency and severity, patients report enhanced mood, reduced daytime sleepiness independent of seizure control, increased slow wave sleep, and improved cognition, memory, and quality of life. The purpose of this study is to demonstrate objective improvement in clinical outcome by placement of a vagus nerve stimulator in patients who are recovering from severe traumatic brain injury. Our hypothesis is that stimulation of the vagus nerve results in increased cerebral blood flow and metabolism in the forebrain, thalamus and reticular formation, which promotes arousal and improved consciousness, thereby improving outcome after traumatic brain injury resulting in minimally conscious or persistent vegetative states. If this study demonstrates that vagus nerve stimulation can safely and positively impact outcome, then a larger randomized prospective crossover trial will be proposed. The investigators will achieve this objective by evaluating whether vagus nerve stimulation impacts clinical recovery from minimally conscious or persistent vegetative states caused by traumatic brain injury as assessed by the FIMâ„¢ instrument and Functional Assessment Measure (FIM+FAM) as well as the JFK Coma Recovery Scale Score. The investigators will also evaluate whether vagus nerve stimulation alters resting and activational functional MRI. Twelve patients will be enrolled in this initial crossover pilot study. These patients will have sustained a severe traumatic brain injury (Disability Rating Scale score of 22 to 29) more than twelve months from starting the study, and have no other concurrent active severe medical problems. Baseline EEG and magnetic resonance imaging (MRI) will be performed prior to left vagus nerve stimulation implantation. Patients will be randomized to alternating three month periods with the device on or off. Outcomes will be assessed at three month intervals with the FIMâ„¢ instrument and Functional Assessment Measure (FIM+FAM) and JFK Coma Recovery Scale by a neuropsychologist blinded to the status of the device. Outcomes will also be assessed using quantitative eye movement tracking and functional magnetic resonance imaging. Patients will cross over every 3 months and be followed for at least 18 months.