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Persistent Vegetative State clinical trials

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NCT ID: NCT06081283 Recruiting - Stroke Clinical Trials

Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

Start date: November 20, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to explore the effect of FDA-approved antiseizure drugs in the brain connectivity patterns of severe and moderate acute brain injury patients with suppression of consciousness. The main questions it aims to answer are: - Does the antiseizure medication reduce the functional connectivity of seizure networks, as identified by resting state functional MRI (rs-fMRI), within this specific target population? - What is the prevalence of seizure networks in patients from the target population, both with EEG suggestive and not suggestive of epileptogenic activity? Participants will have a rs-fMRI and those with seizure networks will receive treatment with two antiseizure medications and a post-treatment rs-fMRI. Researchers will compare the pretreatment and post-treatment rs-fMRIs to see if there are changes in the participant's functional connectivity including seizure networks and typical resting state networks.

NCT ID: NCT05954650 Completed - Clinical trials for Disorder of Consciousness

Clinical Validity of the Minimally Conscious State "Plus" and "Minus"

Start date: September 30, 2004
Phase:
Study type: Observational

The goal of this observational retrospective study is to investigate and compare the clinical evolution of a sample of patients with the diagnosis of MCS+ versus MCS- according to the CRS-R. The main questions it aims to answer are the presence of differences in the likelihood of emergence from the MCS (EMCS) between these two groups and in the progress of disability and functional independence after the EMCS.

NCT ID: NCT05558930 Recruiting - Clinical trials for Disorder of Consciousness

Cerebellar iTBS in Patients With Disorders of Consciousness

CTPDOC
Start date: April 29, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05536921 Completed - Clinical trials for Traumatic Brain Injury

Eye Tracking Technology in the Diagnosis of Neurological Patients

Start date: May 1, 2022
Phase:
Study type: Observational

Demonstrating that diagnostics of the state of consciousness and cognitive functions of patients with consciousness disorders performed using C-Eye X (based on eye-tracking technology) allows a more objective assessment of state of patients who were wrongly diagnosed based on popular methods using in a clinical practice (like behavioural scales on paper forms).

NCT ID: NCT05496985 Completed - Brain Diseases Clinical Trials

Chinese Validation of the Simplified Evaluation of CONsciousness Disorders(SECONDs)

Start date: December 20, 2021
Phase: N/A
Study type: Interventional

The aim of this study was to translate the SECONDs from French into Chinese and assess the validity and reliability of the Chinese version of the SECONDs .

NCT ID: NCT04921683 Completed - Clinical trials for Traumatic Brain Injury

The Use of LIFUP in Chronic Disorders of Consciousness

Start date: June 21, 2021
Phase: N/A
Study type: Interventional

When patients survive a severe brain injury but fail to fully recover, they often enter a Disorder of Consciousness (DoC) --that is, a set of related conditions of decreased awareness and arousal including the Vegetative State (VS) and the Minimally Conscious State (MCS). When these conditions become chronic, there are no approved treatments to help bolster any further recovery. In prior work, we have shown the clinical feasibility and potential of Low Intensity Focused Ultrasound Pulsation (LIFUP) as a remarkably safe form of non-invasive brain stimulation in these conditions.

NCT ID: NCT04798456 Recruiting - Caregivers Clinical Trials

Aiming for a Better Understanding and Improvement of the Diagnosis and Prognosis of Patients With Disorders of Consciousness Through Multimodal Observations

PerBrain
Start date: June 1, 2020
Phase:
Study type: Observational

Improved treatment of severe brain injuries has resulted in increased survival rates. While some of these patients regain consciousness after a transient state of coma, others may develop a disorder of consciousness (DoC). Diagnosis of DoC currently relies on standardized behavioral assessment. The importance of accuracy in such diagnosis cannot be overstated, as it guides critical decisions on treatment (including pain management), and could underlie end-of-life decisions. Despite this importance, current behavioral diagnosis often fails, if because of the major sensory and motor deficits associated with DoC, or because of the heterogeneous etiology and pathophysiology associated with the condition. Finally, the need for accurate diagnosis and prognosis transcends the needs of the patients alone: caregiving of these patients is very stressful, principally for the large uncertainty associated with them. Thus, more accurate diagnosis and prognosis provide major relief for caregivers, and paradoxically, even if the news is not "good". For all these reasons it is critical to developing personalized diagnosis and prognosis prediction tools that permit a stratified analysis at the single-patient level. The PerBrain Project will benefit from the multidisciplinary partners' expertise, and the unique opportunity to perform longitudinal assessments in four clinical sites through both established and novel electrophysiological, neuroimaging, and physiological techniques. Based on the collected data, the investigators will develop a multimodal personalized diagnostic tool for DoC patients using state-of-the-art computational tools, such as machine learning, in order to better determine the current state (diagnosis) and future outcome (prognosis). The overall aim of this project will provide for a better understanding of the pathophysiological mechanisms in DoC, which will, in turn, allow personalized rehabilitation strategies, and improved single-patient predictions of state and prognosis.

NCT ID: NCT04687553 Completed - Clinical trials for Minimally Conscious State

Validation of the Chinese Version of the SECONDs

Start date: November 10, 2020
Phase: N/A
Study type: Interventional

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

NCT ID: NCT04614792 Completed - Clinical trials for Disorder of Consciousness

Excitatory Prefrontal Weak Current Stimulation in Vegetative Patients

VEG-TDCS
Start date: April 30, 2014
Phase: N/A
Study type: Interventional

In response to "conscious" EEG findings related to detectable cognitive function that reliably denote awareness in vegetative state patients, in the current study, we will assess the covert conscious EEG activity (as well as standard clinical overt measures) and neuroplasctic propensity (i.e., changes in EEG spectral power synchronization values following tDCS intervention) in vegetative-state patients receiving repetitive transcranial direct current stimulation (tDCS) treatment over frontal motor areas for a period of two weeks. In support of this approach, a recent tDCS study with vegetative and minimally conscious patients implied that a twenty minutes anodal stimulation (i.e., excitatory stimulation) to the left dorsolateral prefrontal cortex (DLPFC) significantly increased CRS-R scores versus sham (placebo: non-active stimulation) stimulation condition. It was noted that this tDCS effect was more pronounced in minimally conscious state patients versus vegetative state patients excluding effects of chronicity or etiology. Thus, the investigators in this study suggested that tDCS could be effective in improving cognitive recovery in severely brain-injured patients. However, their findings would benefit neural activation correlates that could support their conclusion regarding the effectiveness of this type of non-invasive intervention in promoting neurocognitive recovery. Most importantly, tDCS is safe for use in humans, has no adverse effects, is considered the most non-invasive transcranial stimulation method because it uses extremely weak currents (0.5 to 2 mA), and, is known to only temporarily shift the neuron's membrane potential towards excitation/inhibition. In regard to the method's potential to induce functional recovery in vegetative state patients, recent clinical studies indicate that tDCS could counteract the negative effects of brain damage by influencing neurophysiological mechanisms, and is likely to contribute to the "formation of functionally meaningful connections and the maintenance of existing pathways" .

NCT ID: NCT04499092 Completed - Clinical trials for Acquired Brain Injury

COgnitive REhabilitation in Pediatric Patients With sABI From Vegetative State to Functional Recovery

COREABI
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Acquired brain lesions (GCLA) represent one of the most important cause of disability and mortality during the pediatric age, also in the western Countries. The important medical progresses of the last decade in the medical field have increased the percentages of survival, also in the most severe clinical pictures. On the other hand, a brain lesion reported in the first years of life presents with a more dramatic impact on the cognitive and neurological development of the patients and it can significantly interfere with the same quality of their life. Recent studies suggest that a brain damage in this stage of the life is related to more persistent sequelae in comparison of the same lesion reported by an adult patient, because of the neurological immaturity at the moment of the insult. Furthermore, in most cases, the brain lesion is related not only to motor and sensorial deficits but also to very important behavioral and cognitive problems, that can arise immediately after the acute phase, or also several years after the pathological event.