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

Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo" (Other)
Overall Status
Completed
CT.gov ID
NCT05802524
Collaborator
(none)
20
1
24
0.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Neurowave Group

Study Design

Study Type:
Observational
Actual Enrollment :
20 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Neurophysiological Approach for the Evaluation of Residual Cognitive Functions in Patients With Severe Alterations of Consciousness
Actual Study Start Date :
Jun 14, 2020
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jun 14, 2022

Outcome Measures

Primary Outcome Measures

  1. Event-related evoked potentials(ERPs) [24 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Centro Neurolesi "Bonino-Pulejo" Messina Italy 98124

Sponsors and Collaborators

  • IRCCS Centro Neurolesi "Bonino-Pulejo"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IRCCS Centro Neurolesi "Bonino-Pulejo"
ClinicalTrials.gov Identifier:
NCT05802524
Other Study ID Numbers:
  • Multi-NW
First Posted:
Apr 6, 2023
Last Update Posted:
Apr 6, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2023