This double-blind, placebo-controlled trial (n=30) aims to investigate the efficacy of intravenous subanesthetic doses of ketamine in treating patients with post-comatose disorders of consciousness (DoC), conducted by the University of Liege.
The study involves three phases: baseline assessment using fMRI, PET, and EEG, experimental phase with ketamine or placebo infusion, and follow-up evaluations at 1, 6, and 12 months. Patients will undergo TMS-EEG during ketamine infusion to measure brain activity and complexity.
The primary outcomes include the emergence of new conscious behaviours and higher brain complexity following ketamine infusion. Secondary outcomes focus on baseline differences in neurophysiological and brain imaging measures between responders and non-responders. The study commenced in May 2022 and is expected to conclude by May 2026.
Trial Details
The investigators will run a Randomized Clinical Trial with 30 patients with disorders of consciousness (DoC), with intravenous subanesthetic doses of ketamine. Patients will simultaneously undergo TMS-EEG. The piloting will be done on 3 patients, with EEG only.Trial Number NCT05343507