Condition: Disorder of Consciousness · Sponsor: University of Liege
Background: Patients who survive severe brain injury may develop chronic disorders of consciousness (DoC). Treating these patients to improve recovery is extremely challenging because of scarce and inefficient therapeutical options. Among pharmacological treatments, apomorphine, a potent direct dopamine agonist, has exhibited promising behavioral effects, but its true efficacy and its mechanism remains unknown. This randomized controlled study aims to verify the effects of apomorphine subcutaneous infusion in patients with disorders of consciousness and investigate the neural networks targeted by this treatment. Methods/design: The double-blind randomized controlled trial will include 48 patients: 24 patients will be randomly assigned to the apomorphine and 24 to the placebo group. Investigators and the patients will be unaware of the nature of the treatment rendered. Primary outcome will be determined as behavioral response to treatment as measured by changes of diagnosis using the Coma Recovery Scale - Revised (CRS-R), while secondary outcome measures will include the Nociception Coma Scale - Revised (NCS-R), Disability Rating Scale (DRS), Wessex Head Injury Matrix (WHIM), circadian rhythm using actimetry, electroencephalography (EEG), positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). The Glasgow Outcome Scale - Extended (GOS-E) and a phone-adapted version of the CRS-R will be used for long-term follow-up. Statistical analyses will fo…
This description comes directly from the study's public registry record.
Emilie Szymkowicz, MSc. · +32492319947 · emilie.szymkowicz@uliege.be
Leandro RD Sanz, M.D. · +3243663915 · leandro.sanz@uliege.be
Always discuss trial participation with your own doctor first.
| University of Liege | Liège, Liege, Belgium | Active Not Recruiting |
| Hôpital Valdor - ISoSL | Liège, Liège, Belgium | Recruiting |
| Centre Hospitalier Neurologique William Lennox | Ottignies-Louvain-la-Neuve, Belgium | Recruiting |
| VITHAS | Valencia, Spain | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT05213169