Overview
Ketamine to Treat Patients With Post-comatose Disorders of Consciousness
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2026-05-01
2026-05-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
University of LiegeCollaborators:
Centre Hospitalier Universitaire de LiegeWilliam Lennox Neurological Center UCLouvain
Treatments:
KetamineCriteria
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