Status:
RECRUITING
Ketamine to Treat Patients With Post-comatose Disorders of Consciousness
Lead Sponsor:
University of Liege
Collaborating Sponsors:
Centre Hospitalier Universitaire de Liege
William Lennox Neurological Center UCLouvain
Conditions:
Disorder of Consciousness
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief 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 TM...
Detailed Description
The protocol will be organized in three phases: baseline, experimental, and follow-up. In the baseline, patients will receive a multimodal assessment \[functional magnetic resonance imaging (fMRI), po...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05343507
Start Date
May 1 2022
End Date
May 1 2026
Last Update
November 7 2022
Active Locations (1)
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1
Centre Hospitalier Neurologique William Lennox
Ottignies-Louvain-la-Neuve, Wallonia, Belgium, 1340