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

March 27, 2023 updated by: IRCCS Centro Neurolesi "Bonino-Pulejo"

Neurophysiological Approach for the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Diagnostic test: Neurowave Group

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Messina, Italy, 98124
    - IRCCS Centro Neurolesi "Bonino-Pulejo"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Departments of Serious Acquired Brain Injuries

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Centro Neurolesi "Bonino-Pulejo"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2020

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 14, 2022

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)