RecruitingPhase 2ketamine

Ketamine to Treat Patients With Post-comatose Disorders of Consciousness

NCT ID

NCT05343507

Target Enrollment

30 participants

Start Date

2022-05-01

Est. Completion

2026-05-01

About This Study

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.

Conditions Studied

Disorder of Consciousness

Interventions

•Ketalar 50 MG/ML Injectable Solution
•Placebo

Eligibility

Age:18 Years - 65 Years

Healthy Volunteers:No

View full eligibility 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

Study Locations (1)

Centre Hospitalier Neurologique William Lennox

Ottignies-Louvain-la-Neuve, Wallonia, Belgium