Cognitive Impairment Clinical Trial
Official title:
Neurophysiological Approach for the Evaluation of Residual Cognitive Functions in Patients With Severe Alterations of Consciousness
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 |
Verified date | March 2023 |
Source | IRCCS Centro Neurolesi "Bonino-Pulejo" |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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). |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Centro Neurolesi "Bonino-Pulejo" | Messina |
Lead Sponsor | Collaborator |
---|---|
IRCCS Centro Neurolesi "Bonino-Pulejo" |
Italy,
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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