Study of Apomorphine Infusion for Treatment in Adults with Severe Brain Injury Disorders of Consciousness

What this Trial Is About

Researchers are evaluating the effects of apomorphine, a dopamine agonist, in patients who have survived severe brain injuries and developed chronic disorders of consciousness DoC. This randomized controlled trial aims to verify the impact of apomorphine subcutaneous infusion on behavioral recovery and to study the brain networks involved in the treatment response. The study addresses the urgent need for effective therapies in this challenging patient population. Participants will be randomly assigned to receive either apomorphine hydrochloride or a placebo via continuous subcutaneous infusion pump. The apomorphine group undergoes a 30-day treatment with a titration phase increasing from 0 to 4 mgh over 5 days, followed by 18 days at 4 mgh or up to 6 mgh depending on tolerance. Domperidone is administered to reduce side effects starting 2 days before apomorphine. The placebo group receives a sodium chloride infusion following the same schedule. Throughout the study, participants will be closely monitored using multiple behavioral scales including the Coma Recovery Scale - Revised and others to assess response to treatment. Brain function and metabolism will be evaluated with EEG, PET, and fMRI scans. Circadian rhythms will be tracked using actimetry and body temperature. Long-term outcomes will be followed up to 24 months post-treatment using phone assessments. Safety and efficacy data will be analyzed at both individual and group levels over a 90-day treatment and observation period.

Apomorphine in Severe Brain-injured Patients