RecruitingPhase 2Phase 3NCT05343507

Ketamine to Treat Patients With Post-comatose Disorders of Consciousness

Complexity-enhancing Drugs to Treat Disorders of Consciousness (DoC): a Ketamine Study

Sponsor

University of Liege

Enrollment

30 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

Disorder of Consciousness

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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 Criteria8

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGKetalar 50 MG/ML Injectable Solution

Intravenous solution (other info already provided)

DRUGPlacebo

Saline Solution

Locations(1)

Centre Hospitalier Neurologique William Lennox

Ottignies-Louvain-la-Neuve, Wallonia, Belgium

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05343507

Related Trials

Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousness Disorders

NCT068962792 locations

Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial

NCT064699836 locations