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

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.

Completed

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Key information

Conditions

Consciousness Disorder Cognition Disorders Cognitive Dysfunction Cognitive Impairment Consciousness Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, 98124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Glasgow Coma Scale (GCS) > 8;

Level of Cognitive Scale (LCF) = 1-3;

Signature of the consent from the family member and/or guardian.

Exclusion criteria

Failure to sign the consent of the family member and/or legal guardian;

Patients with cranial anatomical alterations that do not allow the correct assembly of the electrodes, caps, etc.;

Patients with absence of neurophysiological responses in visual evoked potentials (VEP) and with absence of peripheral waves (I-II wave) to acoustic potentials (PEA).

Treatment and study plan

Neurowave Group

Diagnostic Test

Neurosensory stimulation will consist in the administration of pairs of stimuli consisting of emotionally significant images and sounds in the personal life history (two rare stimuli) alternating with neutral images and sounds devoid of emotional significance (two "distracting" stimuli

Primary outcomes

Event-related evoked potentials(ERPs)

Time frame: 24 months

Event-related evoked potentials(ERPs) are variations of the electric potential deriving from a visual, somesthetic or auditory stimulus.

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Apr 6, 2023
Registry last updated: Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed