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Consciousness Disorders clinical trials

View clinical trials related to Consciousness Disorders.

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NCT ID: NCT05802524 Completed - Clinical trials for Cognitive Impairment

Neurophysiological Evaluation of Residual Cognitive Functions in Patients With Severe Alterations of Consciousness

Start date: June 14, 2020
Phase:
Study type: Observational

Identify potential markers of recovery through event-related potentials (ERPs) in the evolution of altered consciousness with potential ability to discriminate between different conditions of altered state of consciousness. Identify potential markers with prognostic value, in order to identify personalized and specific intensive rehabilitation paths based on the outcome indexes obtained.

NCT ID: NCT05747170 Active, not recruiting - Clinical trials for Disorder of Consciousness

Olfactory Stimulation in Severe Brain Injury

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

The management of patients with disorders of consciousness (DoC) represents a topic of great importance and topicality in the medical-scientific field because of the complexity and extent of associated disabilities and the difficulty in identifying effective therapeutic approaches. Despite significant advances in neuroscience, much remains to be elucidated about the mechanisms that regulate consciousness, and which of these to act on to stimulate plasticity and thus promote responsiveness and functional recovery in patients. Evidence on treatments that promote arousal and communication skills in individuals with DoC is still limited. Among the possible interventions proposed in the literature, sensory stimulation would act by stimulating synaptic plasticity, counteracting the sensory deprivation to which these patients are exposed. Published studies on the topic have produced results that are not unique and difficult to compare across different stimulation protocols (content, intensity, frequency, modality), settings and patient populations.

NCT ID: NCT05740735 Recruiting - Clinical trials for Disorder of Consciousness

Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness

ExpressComa
Start date: March 25, 2024
Phase:
Study type: Observational

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.

NCT ID: NCT05734183 Active, not recruiting - Clinical trials for Acquired Brain Injury

Multisensorial IMmersive Experiences (MIME) in Disorders of Consciousness

MIME
Start date: October 29, 2021
Phase: N/A
Study type: Interventional

Disorder of consciousness (DoC) is a state in which consciousness is altered because of brain damage and can occur under a variety of conditions: in fact, the most frequent causes of DoC are vascular disease, head trauma, and cerebral hypoxia. DoCs result from the loss of regulation of neural function of the two components of consciousness, alertness and awareness. Depending on the patient's behavior and responsiveness, DoCs can be identified in different states, from coma to persistent vegetative state (VS) to intermittent minimally conscious state (MCS). Regarding the prognosis of recovery, in patients with DoC the chance of having functional improvement decreases with time, although some positive functional changes have been observed in chronic patients. Therapies for DoC include some drugs, such as dopaminergic, GABAergic and amantadine drugs, which work to facilitate the recovery of consciousness. Neurorehabilitation, however, seems to be the most recognized intervention that aims to strengthen, in uninjured brain regions, the spontaneous neuroplasticity that occurs to compensate for lost function. Simultaneous stimulation of multiple senses, such as hearing, sight and smell, provides the neural network with more stimuli that are more effective than a single stimulus. In fact, multisensory stimuli can more easily activate attention because cortical processing is predominantly multimodal. As for content, it would seem that those with autobiographical and emotionally salient character could engage multiple brain networks and have priority access to attention. Numerous trials show that stimulus-containing content led to increased behavioural activity, improving self-awareness in patients with DoC. Considering that a communication system that can combine both visual and auditory channels proves to be more effective than a "single-sense" channel, multisensory stimulation is likely to provide simultaneous activation of different brain areas by enhancing plasticity processes. Furthermore, the intensity of stimulation could be one of the main variables with greater impact on the patient: in fact, higher intensity would correspond to a greater effect on the brain.

NCT ID: NCT05714215 Recruiting - Clinical trials for Disorder of Consciousness

SECONDs' Italian Translation and Transcultural Validation

IT-SECONDs
Start date: October 28, 2021
Phase:
Study type: Observational

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

NCT ID: NCT05706831 Recruiting - Stroke Clinical Trials

Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT05682248 Enrolling by invitation - Clinical trials for Disorder of Consciousness

Study of Brain Function Evaluation and Intervention System for Acute and Prolonged Disorders of Consciousness

Start date: April 13, 2022
Phase: N/A
Study type: Interventional

The research focuses on establishing a system for validating the effectiveness of key technologies for targeted combined non-invasive interventions in awakening consciousness.

NCT ID: NCT05670873 Not yet recruiting - Ischemic Stroke Clinical Trials

Transcranial Magnetic Stimulation in Disorder of Consciousness in Acute Severe Cerebrovascular Disease Patients

I-HELP
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

This study is aimed at evaluating the potential of transcranial magnetic stimulation in patients with acute severe ischemic stroke with DoC while assessing patients with a hybrid neural network evaluation model. This model may be the basis for initiating individualized closed-loop neuromodulation treatment in patients with DoC.

NCT ID: NCT05640544 Recruiting - Clinical trials for Disorder of Consciousness

Gamma Entrainment Improve the Recovery of Awareness

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

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.

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.