Ketamine to Treat Patients With Post-comatose Disorders of Consciousness

• Status: Not yet recruiting
• Trial end date: 2026-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Liege
• Collaborators: Centre Hospitalier Universitaire de Liege; William Lennox Neurological Center UCLouvain
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• Clinically stable

• Diagnosis of UWS or MCS based on repeated "coma recovery scale-revised) (CRS-R) or SECONDs

• More than 28 days post-insult

• Informed consent from the legal representative of the patient

Exclusion Criteria:

• Neurological medications other than anti-spasticity drugs in the last 2 weeks or 4 half-lives

• Previous neurological functional impairment other than related to their DoC

• A history of psychotic disorders

• Contraindication to MRI, EEG, PET or TMS

• Use of nitrates or other vasodilators, central nervous system acting agents such as barbiturates, morphine and related drugs.

• Use of drugs known to interact with ketamine (i.e., CYP3A4, diazepam, ...)

• Coronary insufficiency

• Other sympathomimetic drugs