In short
Currently, there is 1 ongoing clinical trial investigating treatment approaches for patients with conditions affecting brain electrical activity following severe acute brain injury. This trial is being conducted in Denmark and focuses on testing a medication called esketamine hydrochloride to help reduce abnormal brain wave activity that can worsen outcomes after brain injuries.
Clinical trial locations
- Denmark
Study on Esketamine Hydrochloride and Sodium Chloride for Patients with Severe Acute Brain Injury
This trial is investigating the use of esketamine hydrochloride in patients who have suffered severe acute brain injuries, including subarachnoid hemorrhage (bleeding around the brain), intracerebral hemorrhage (bleeding within the brain tissue), or traumatic brain injury (damage caused by external force to the head).
Main inclusion criteria: To participate in this study, patients must be at least 18 years old and admitted to the Neurointensive Care Unit with one of the qualifying brain injury diagnoses. Participants need to be scheduled for brain surgery involving either a supratentorial craniotomy (where part of the skull is temporarily removed to access the upper brain) or craniectomy (where part of the skull is removed to relieve pressure). After surgery, patients must be expected to remain on sedation (medication to help them relax or sleep) and mechanical ventilation (a machine that helps with breathing).
Main exclusion criteria: Patients cannot participate if they have a previous history of subarachnoid hemorrhage, intracerebral hemorrhage, or traumatic brain injury before the current event.
Main focus and goal: The trial aims to determine how effective and safe esketamine hydrochloride is in reducing abnormal brain wave activity called cortical spreading depolarisations. These are waves of electrical disturbance that can spread across the brain after injury and potentially worsen the damage. Researchers will monitor how often these brain activities occur during treatment and track any side effects. The study will also follow participants for six months after treatment to evaluate their recovery and functional abilities using standard assessment scales.
Investigational drug: The trial is testing S-ketamine (esketamine hydrochloride), which is given through an intravenous infusion for up to 14 days. S-ketamine works by blocking specific receptors in the brain called NMDA receptors, which are involved in pain transmission and the development of these harmful brain wave disturbances. The medication will be compared against sodium chloride (a saline solution) to understand its specific effects.
Summary
This single ongoing trial represents an important investigation into new treatment options for patients with severe brain injuries. The study is being conducted in Denmark and focuses specifically on addressing cortical spreading depolarisations, which are abnormal brain wave patterns that can complicate recovery after brain injury. The trial is testing esketamine hydrochloride, a medication that works differently from standard treatments by targeting specific brain receptors involved in these electrical disturbances. Results from this study could provide valuable insights into whether this approach can improve outcomes for patients recovering from serious brain injuries such as hemorrhages and trauma.
