Detecting signatures of consciousness in acute brain injury after stimulation with apomorphine and methylphenidate: Protocol for a placebo-controlled, randomized, cross-over study
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Methods In a placebo-controlled, randomised, cross-over setting, we evaluate the effect of methylphenidate and apomorphine in 50 DoC patients with acute traumatic or non-traumatic brain injury admitted to the ICU. Patients are examined before and after administration of the trial drugs using (1) neurobehavioural scales to determine the clinical level of consciousness, (2) automated pupillometry to record pupillary responses as a signature for awareness and (3) near-infrared spectroscopy combined with electroencephalography to record neurovascular coupling as a measure for cortical activity. Primary outcomes include pupillary dilations and increase in cortical activity during passive and active paradigms.
Ethics The study has been approved by the ethics committee (Journal-nr: H-21022096) and follows the principles of the Declaration of Helsinki. It is deemed to pose minimal risks and to hold a significant potential to improve treatment options for DoC patients. If the stimulants are shown to enhance cortical modulation of pupillary function and neurovascular coupling, this would warrant a large multicentre trial to evaluate their clinical impact.
Originalsprog | Engelsk |
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Artikelnummer | e000584 |
Tidsskrift | BMJ Neurology Open |
Vol/bind | 6 |
Udgave nummer | 1 |
Antal sider | 11 |
DOI | |
Status | Udgivet - 2024 |
Bibliografisk note
Funding Information:
This study has received funding from Region Hovedstadens Forskningsfond, Rigshospitalets Forskningspuljer, Offerfonden (journal nr.: 19-610-00060) and Jascha Fonden in support of health care research. The funding will go to remuneration of the primary investigator’s Ph.D. programme and expenses related to medication, devices and data analysis. The contributors have no financial interest in the study. There are no conflicts of interest. The study participants receive no financial compensation.
Publisher Copyright:
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
ID: 381058097