Ongoing Clinical Trials for Coma
There are currently 5 ongoing clinical trials exploring new treatments for patients in coma. These studies are investigating various approaches including anti-seizure medications, consciousness-enhancing drugs, neuroprotective solutions, and infection prevention strategies. The trials are being conducted across several European countries: Belgium, Denmark, the Netherlands, and Spain.
Clinical trial locations
- Belgium
- Denmark
- Netherlands
- Spain
Study of anti-seizure drug combination in comatose patients with status epilepticus after cardiac arrest
This trial is designed for patients who remain unconscious after surviving a cardiac arrest and who develop status epilepticus, which is a dangerous condition of continuous seizure activity. The study is being conducted in Belgium and the Netherlands.
Who can participate: You may be eligible if you are at least 18 years old and in a deep state of unconsciousness following an out-of-hospital cardiac arrest. Your brain activity must be monitored with an EEG started within 24 hours after your heart started beating again. The EEG must show signs of evolving status epilepticus, and treatment must be able to begin within 3 hours of detecting this seizure activity.
Who cannot participate: You cannot join this study if you are under 18 years old, have a terminal illness, have pre-existing severe brain damage affecting daily function, have had previous cardiac arrests, are allergic to the study medications, are pregnant or breastfeeding, are already taking anti-seizure medications, have severe liver or kidney problems, had brain surgery in the past 30 days, or have a history of drug-resistant epilepsy.
What the trial involves: The study compares patients who receive anti-seizure treatment with those who do not. If assigned to the treatment group, you will receive several anti-seizure medications through a vein, including diazepam, midazolam, lorazepam, propofol, esketamine, lacosamide, levetiracetam, and sodium valproate. These are given in a step-by-step approach to stop seizure activity. Your brain activity will be continuously monitored throughout your hospital stay, and your recovery will be assessed six months after the cardiac arrest through a telephone interview.
Investigational drugs: The trial uses multiple anti-seizure medications administered intravenously, including diazepam, midazolam, lorazepam, propofol, esketamine, lacosamide, levetiracetam, and sodium valproate, given in sequence to control seizure activity.
Study on Apomorphine and Psilocybin for Recovery in Coma Patients with Acute Brain Injury
This Danish trial explores whether two experimental treatments can help improve consciousness levels in patients who are unresponsive due to sudden brain injuries. The study is focused on finding safe doses for these treatments in critically ill patients.
Who can participate: You must be at least 18 years old and in the Intensive Care Unit in a state where you are not responding to stimuli due to a brain injury or other serious condition causing unconsciousness. Your doctors must expect your unconscious state to last for at least 3 days.
Who cannot participate: You cannot participate if you are not in a state of unconsciousness or altered consciousness, do not have an acute brain injury, are not in the ICU, or are responsive to your surroundings.
What the trial involves: The study uses two main medications: apomorphine and psilocybin. Apomorphine is given through a subcutaneous infusion, while psilocybin is given as a capsule taken orally. The study monitors how quickly patients regain consciousness within 30 days, along with eye responses and brain activity at days 1 and 7. Follow-up assessments continue until day 90 to evaluate overall recovery and any side effects.
Investigational drugs: Apomorphine works by stimulating dopamine receptors in the brain to enhance alertness and awareness. Psilocybin activates serotonin receptors, which may influence perception and mood. Both are being tested to determine safe and effective doses for improving consciousness in brain injury patients.
Study on the Effects of Sodium Lactate and Electrolyte Solution in Comatose Patients After Cardiac Arrest
This Belgian trial examines whether a special solution containing sodium lactate can help reduce brain injury in patients who remain unconscious after cardiac arrest. The goal is to protect the brain from further damage after the heart has been restarted.
Who can participate: You must be over 18 years old and have remained in a state of unconsciousness after your heart spontaneously started beating again for at least 20 minutes following cardiac arrest. Your Glasgow Coma Scale score must be less than 9, and the time to return of circulation must have been more than 15 minutes.
Who cannot participate: You cannot participate if you have a brain injury unrelated to oxygen deprivation, are not in a comatose state, have not experienced cardiac arrest, do not have post-cardiac arrest syndrome, or fall outside the specified age range.
What the trial involves: Participants receive an infusion of hypertonic sodium lactate solution along with an electrolyte solution called Plasmalyte A Viaflo through an intravenous line. The primary measurement involves checking levels of a specific protein in your blood 48 hours after your heart restarted. The study also tracks your recovery score at 90 days, length of stay in intensive care, mortality rates, and various blood protein levels at different time points.
Investigational drugs: Hypertonic sodium lactate is an infusion solution that provides an energy source to the brain, potentially improving cell metabolism and reducing injury after cardiac arrest. The solution is being studied for its potential to protect brain tissue from further damage.
Study on Preventing Early Respiratory Infections in Intubated Patients Using Ceftriaxone, a Cough Simulator, and Subglottic Secretion Aspiration
This Spanish trial focuses on preventing lung infections in patients who require a breathing tube due to reduced consciousness from severe trauma, brain injury, stroke, cardiac arrest, or other causes. The study tests three approaches: an antibiotic, a device that simulates coughing, and a method to remove secretions from the throat area.
Who can participate: You must be over 17 years old and have a breathing tube expected to remain in place for more than 48 hours. You must have one of the following conditions: severe trauma or head trauma, stroke (either from blockage or bleeding), successful resuscitation after cardiac arrest, harmful substances affecting your brain and spinal cord, or status epilepticus (prolonged seizures).
Who cannot participate: You cannot participate if you have reduced consciousness due to severe trauma, traumatic brain injury, stroke, cardiac arrest, or other unspecified causes. Note that the exclusion criteria appear to overlap with inclusion criteria, which may indicate specific subtypes or severities being excluded.
What the trial involves: Participants receive a short course of the antibiotic ceftriaxone given through a vein. Additionally, two methods are used to help clear the airways: a cough simulator device and aspiration of secretions that build up above the breathing tube. The study monitors for serious side effects and respiratory infections for 14 days, then tracks additional outcomes like duration of breathing support, intensive care stay length, and overall health up to 90 days.
Investigational drugs: Ceftriaxone is a systemic antibiotic that kills or stops the growth of bacteria. The cough simulator helps clear mucus from the lungs by mimicking natural coughing. Subglottic secretion aspiration removes secretions from just above the breathing tube to prevent them from entering the lungs and causing infection.
Study on Psilocybin and Apomorphine for Improving Consciousness in Patients with Coma and Brain Injury
This Danish trial investigates whether psilocybin and apomorphine can help patients regain consciousness after brain injuries. The study aims to determine if these treatments can improve awareness and responsiveness in unconscious patients.
Who can participate: You must be at least 18 years old and in a state where you do not respond to stimuli due to a brain injury (from accident or other causes) or a medical or surgical condition causing unconsciousness not related to medication. Your doctors must expect your unconscious state to last at least 3 days.
Who cannot participate: You cannot participate if you are not in a state of unconsciousness or altered consciousness, have not experienced a brain injury, are outside the specified age range, do not belong to the specific clinical trial group being studied, or are not part of the vulnerable population selected for the study.
What the trial involves: Participants receive either a single oral dose of psilocybin (25 mg in capsule form) or apomorphine given as a subcutaneous infusion. Some patients may receive a placebo for comparison. Your consciousness levels are measured within 3 to 6 hours after treatment using specialized scoring systems. Additional assessments include pupil reactions to light and brain activity measurements on days 1 and 7. Your overall recovery is evaluated at day 90, and the study tracks the number of days you are alive outside the ICU.
Investigational drugs: Psilocybin activates serotonin receptors in the brain, which may help stimulate awareness and consciousness. Apomorphine stimulates dopamine receptors, potentially affecting alertness and motor control. Both are being studied for their ability to enhance consciousness levels in brain injury patients.
Summary
The five ongoing clinical trials for patients in states of unconsciousness represent diverse approaches to improving outcomes. Two trials are focused specifically on cardiac arrest survivors, examining anti-seizure treatment and neuroprotective solutions. Two Danish trials are exploring innovative consciousness-enhancing drugs, including psilocybin and apomorphine, representing a novel approach to treating disorders of consciousness. One Spanish trial addresses the practical challenge of preventing respiratory infections in intubated patients.
Belgium hosts two trials, both focused on cardiac arrest-related conditions, while Denmark leads in exploring consciousness-enhancing medications with two trials. The Netherlands and Spain each host one trial. The studies reflect different strategies: immediate intervention with anti-seizure medications, neuroprotection with specialized solutions, consciousness enhancement with experimental drugs, and infection prevention in critically ill patients. Most trials are designed for adults aged 18 and older, with intensive monitoring in ICU settings and follow-up periods ranging from 14 days to 6 months.
