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NCT05802524 Clinical Trial

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

Cognitive Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05802524
Other study ID # Multi-NW
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 14, 2020
Est. completion date June 14, 2022

Study information
Verified date March 2023
Source IRCCS Centro Neurolesi "Bonino-Pulejo"
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 14, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Neurowave Group
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

Locations
Country Name City State
Italy IRCCS Centro Neurolesi "Bonino-Pulejo" Messina

Sponsors (1)
Lead Sponsor Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Event-related evoked potentials(ERPs) Event-related evoked potentials(ERPs) are variations of the electric potential deriving from a visual, somesthetic or auditory stimulus. 24 months
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