Overview

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