Status:
COMPLETED
Use of Analgesic Treatment to Reduce Signs of Pain in Patients With Disorders of Consciousness.
Lead Sponsor:
University of Liege
Conditions:
Disorders of Consciousness
Severe Brain Injury
Eligibility:
All Genders
16-99 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to characterize and improve pain and nociception management in patients with disorders of consciousness (DOC). This project is divided into two phases, a first phase to ev...
Detailed Description
The study will be performed within one week (i.e, 7 days) and consists of two phases: * Phase 1 "Patients selection (D0)": Patients will be assessed by the NCS-R during experimental stimulation (rest...
Eligibility Criteria
Inclusion
- Have had an acquired brain injury with a loss of consciousness \> 28 days (patients) or have no history of previous brain injury (healthy controls)
- Legally authorized surrogate available to provide informed consent.
- Diagnosis of vegetative/unresponsive (VS/UWS) or minimally conscious state (MCS) or emergence of the minimally conscious state without communication (eMCS; as defined by the CRS-R, see above).
- Medically stable (i.e., no systemic illness or disease).
- Patients with NCS-R score during mobilization above or equal to the previously determined cut-off score or NCS-R scores during mobilization equivalent to NCS-R score obtain during nociceptive stimulation will be included in the second phase of the study (i.e. D1 and D2).
Exclusion
- History of developmental, neurologic, or major psychiatric disorder resulting in functional disability.
- Contraindication or unwillingness to discontinuing sedating and centrally-active drugs (benzodiazepine, long-acting sedating drugs) within 48 hours of assessment.
- Upper limb contusions, fractures or flaccid paralysis.
- Uncontrolled epilepsy and already on level 1 drugs
Key Trial Info
Start Date :
February 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04330547
Start Date
February 21 2018
End Date
April 28 2021
Last Update
May 3 2021
Active Locations (1)
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1
Centre Hospitalier Universitaire de Liège
Liège, Belgium, 4000