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Clinical Trials/NCT05802524
NCT05802524
Completed
N/A

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

IRCCS Centro Neurolesi "Bonino-Pulejo"1 site in 1 country20 target enrollmentJune 14, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Consciousness Disorder
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
Enrollment
20
Locations
1
Primary Endpoint
Event-related evoked potentials(ERPs)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 14, 2020
End Date
June 14, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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).

Outcomes

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.

Study Sites (1)

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