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
• Status: Completed
• 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
• 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).

Related Conditions & MeSH terms

• Cognitive Impairment
• Consciousness Disorder
• Consciousness Disorders

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