EUCTR2021-001453-31-DK
Active, not recruiting
Phase 1
Automated pupillometry and NIRS-EEG to detect signatures ofconsciousness in acute brain injury after apomorphine andmethylphenidate stimulation: A placebo-controlled, randomized, cross-overstudy
Copenhagen University Hospital Rigshospitalet0 sites41 target enrollmentMarch 22, 2021
ConditionsWe investigate the possible effects of commercially availableapomorphine and methylphenidate on signatures of consciousness inpatients admitted to the ICU with acute disorder of consciousness, usingautomated pupillometry and NIRS-EEG.MedDRA version: 20.0Level: HLTClassification code 10013509Term: Disturbances in consciousness NECSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10067967Term: Brain injurySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- We investigate the possible effects of commercially availableapomorphine and methylphenidate on signatures of consciousness inpatients admitted to the ICU with acute disorder of consciousness, usingautomated pupillometry and NIRS-EEG.
- Sponsor
- Copenhagen University Hospital Rigshospitalet
- Enrollment
- 41
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \= 18 years.
- •Fluent in Danish or English language
- •Patients with severe acute traumatic or non\-traumatic brain injury in a
- •state of vegetative state/unresponsive wakefulness syndrome or
- •minimal consciousness state according to FOUR and SECONDs.
- •Written informed consent for trial participation from next\-of\-kin.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 20
Exclusion Criteria
- •Recovery of the ability to follow commands clinically prior to
- •enrollment.
- •Pre\-existing disorder of consciousness before the onset of brain injury.
- •Pre\-existing mental or physical impairments.
- •Deafness, blindness or bilateral eye surgery before the onset of brain
- •Ongoing use of dopamine agonists or antagonists within 6 half\-lives of
- •Ongoing or previous use of psychoactive or psychotropic substances 2
- •weeks prior examination or within 6 half\-lives of the drug.
- •Clinically unstable patients requiring immediate neurological, medical
- •or surgical management.
Outcomes
Primary Outcomes
Not specified
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