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Ketamine to treat patients with post-comatose disorders of consciousness
EU CTIS ID: 2024-518433-29-00
What this study is testing
This clinical trial aims to evaluate the efficacy of intravenous ketamine for the treatment of patients with disorders of consciousness (DoC) after a coma and assess the prevalence of responders.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- More than 18 years old
- Clinically stable, not dependent on medical ventilators for respiration
- Diagnosed as an unresponsive wakefulness syndrome, a minimally conscious state, or emergent from the minimally conscious state according to the international criteria and based on at least 2 standardized behavioral assessments with the Simplified Evaluation of CONsciousness Disorders (SECONDs)
- More than 28 days post-insult
- Informed consent from a legal representative of the patient
You likely can't join if
- Known allergy or hypersensitivity to ketamine
- Active epilepsy (contrary advice by a neurologist upon standard EEG)
- A history of previous neurological functional impairment other than related to their acquired brain injury
- A history of psychotic disorders (schizophrenia or bipolar disorder)
- Use of drugs known to interact with ketamine. Among them: thyroid hormones, diazepam and barbitudes, drugs that interact with CYP3A4, other anesthetic like tramadol or anestethic halogen
- Patient with coronary insufficiency
See the full eligibility criteria
- More than 18 years old
- Clinically stable, not dependent on medical ventilators for respiration
- Diagnosed as an unresponsive wakefulness syndrome, a minimally conscious state, or emergent from the minimally conscious state according to the international criteria and based on at least 2 standardized behavioral assessments with the Simplified Evaluation of CONsciousness Disorders (SECONDs)
- More than 28 days post-insult
- Informed consent from a legal representative of the patient
- Known allergy or hypersensitivity to ketamine
- Active epilepsy (contrary advice by a neurologist upon standard EEG)
- A history of previous neurological functional impairment other than related to their acquired brain injury
- A history of psychotic disorders (schizophrenia or bipolar disorder)
- Use of drugs known to interact with ketamine. Among them: thyroid hormones, diazepam and barbitudes, drugs that interact with CYP3A4, other anesthetic like tramadol or anestethic halogen
- Patient with coronary insufficiency
- Other sympathomimetic drugs
- Pregnancy
- Conditional exclusion criteria: contraindication to MRI, PET, or TMS (e.g., electronic implanted devices, external ventricular drain). In case of those, the participant would be included only for the techniques without contradiction.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.