Can apomorphine and methylphenidate increase signs of consciousness inpatients suffering with disorder of consciousness following severe braininjury?

Phase 1

• 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.; MedDRA version: 20.0Level: HLTClassification code 10013509Term: Disturbances in consciousness NECSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.1Level: PTClassification code 10067967Term: Brain injurySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2021-001453-31-DK
• Lead Sponsor: Copenhagen University Hospital Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-22
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 41

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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
injury.
• Ongoing use of dopamine agonists or antagonists within 6 half-lives of
the drug.
• 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.
• Relatives' refusal of consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified