Using ketamine to help patients with disorders of consciousness
Complexity-enhancing Drugs to Treat Disorders of Consciousness (DoC): a Ketamine Study
PHASE2; PHASE3 · University of Liege · NCT05343507
This study is testing if low doses of ketamine can help people with disorders of consciousness show signs of awareness and improve brain activity.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Liege (other) |
| Locations | 1 site (Ottignies-Louvain-la-Neuve, Wallonia) |
| Trial ID | NCT05343507 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of intravenous subanesthetic doses of ketamine on patients with disorders of consciousness (DoC). It involves a randomized, controlled design with 30 participants undergoing a series of assessments including fMRI, PET, and EEG. Patients will receive either ketamine or a placebo in two sessions spaced five days apart, with brain activity monitored through TMS-EEG to evaluate changes in consciousness and brain complexity. The study aims to identify new signs of consciousness and measure neurophysiological differences between responders and non-responders.
Who should consider this trial
Good fit: Ideal candidates are clinically stable patients diagnosed with unresponsive wakefulness syndrome (UWS) or minimally conscious state (MCS) who are more than 28 days post-insult.
Not a fit: Patients with a history of psychotic disorders or those on certain neurological medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new treatment options for patients with disorders of consciousness, potentially improving their quality of life.
How similar studies have performed: While the use of ketamine in this context is novel, previous studies have shown promising results with psychedelics in altering consciousness levels.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ottignies-Louvain-la-Neuve, Wallonia
- Centre Hospitalier Neurologique William Lennox — Ottignies-Louvain-la-Neuve, Wallonia, Belgium (RECRUITING)
Study contacts
- Principal investigator: Olivia Gosseries, PhD — Coma Science Group (ULiege) & Centre du Cerveau2 (CHU Liege)
- Study coordinator: Paolo Cardone, MSc
- Email: p.cardone@uliege.be
- Phone: 0456309880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Disorder of Consciousness, Psychedelics, Complexity, Ketamine, Clinical Diagnosis, Consciousness level