Status:
UNKNOWN
Pain Protocol: Nociception Coma Scale-Revised With Personalized Stimulus
Lead Sponsor:
I.R.C.C.S. Fondazione Santa Lucia
Conditions:
Disorder of Consciousness
Eligibility:
All Genders
18-65 years
Brief Summary
The goal of this observational study is to compare Nociception Coma Scale-Revised Recorded (NCS-R) scores obtained with the standard pressure on fingernail bed (standard stimulus, SS) versus other per...
Eligibility Criteria
Inclusion
- severe acquired brain injury (sABI),
- clinical history and neuroimaging (brain CT and/or MRI) and fulfilling the criteria proposed for the sABI diagnosis:
- Glasgow Coma Scale (GCS) score ≤ 8 within 24 hours after injury,
- diagnosis of disorders of consciousness (DoC), (VS/UWS or MCS), according to the Coma Recovery Scale-Revised (CRS-R),
- interval from the acute event of at least 3 months.
Exclusion
- history of previous brain injury,
- neurological or psychiatric disorders,
- alcohol or illicit drug abuse and concomitant spinal cord injury
Key Trial Info
Start Date :
July 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06012357
Start Date
July 9 2019
End Date
December 31 2023
Last Update
August 25 2023
Active Locations (1)
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1
Rita Formisano
Rome, Italy, 00179