Ongoing Clinical Trials for Craniocerebral Injury
There are currently 6 clinical trials investigating new approaches to treating and understanding craniocerebral injury. These studies are taking place across Europe, including Sweden, France, Belgium, Italy, Romania, and the Netherlands. The trials explore various treatments ranging from advanced imaging techniques to help understand brain damage, to experimental medications and cell-based therapies aimed at improving recovery after traumatic brain injury.
Clinical trial locations
- Belgium
- France
- Italy
- Netherlands
- Romania
- Sweden
Study of Brain Injury and Concussion Symptoms Using Tau Tracer [18F]RO6958948 in Patients with Traumatic Brain Injury and Hemorrhages
This study, taking place in Sweden, uses advanced brain imaging to understand how different types of brain injuries affect the brain. The research focuses on a protein called tau, which may build up in the brain after injury.
Who can participate: This trial is open to adults aged 18-60 years who have experienced certain types of brain injuries including traumatic brain injury, bleeding inside the brain, or bleeding around the brain. These patients must have been treated in an intensive care unit, and their families must not object to their participation. The study also includes athletes aged 18-40 years who have had at least one concussion during sports with symptoms lasting at least 6 months. All participants must be stable enough to undergo a PET scan and be able to understand the study information.
Who cannot participate: People with mild brain injuries (cerebral commotio) or those with specific types of bleeding in the brain are excluded from this study.
What the study aims to do: The main goal is to determine whether tau protein levels are increased in the brains of people with these injuries compared to healthy individuals, and to identify which specific areas of the brain show these changes. This information could help doctors better understand the long-term effects of brain injuries and concussions.
Treatment being tested: The study uses an imaging agent called [18F]RO6958948, which is injected into the bloodstream. This special tracer helps make the tau protein visible during PET scans, allowing researchers to see where it accumulates in the brain.
Study on Dopaminergic Pathway Disruption in Comatose Patients with Traumatic Brain Injury Using [18F]LBT-999
This French study investigates how severe brain injuries affect dopamine systems in the brain, which play an important role in movement, mood, and consciousness. The research focuses on patients who are in a coma after brain trauma.
Who can participate: Adults aged 18-65 years who have experienced a non-penetrating brain injury within the last 30 days are eligible. Participants must have been in a coma when first admitted to hospital (measured by a Glasgow Coma Scale score of less than 10) and must have stopped taking sedative medications for more than 48 hours. They need to be stable enough to be safely transported to an imaging center for scans. The study includes both patients still in a coma and those who have started to regain consciousness, as well as healthy control subjects matched by age and sex.
Who cannot participate: People who are not in a coma due to severe brain injury, those outside the specified age range, and individuals considered part of vulnerable populations are excluded.
What the study aims to do: The trial seeks to understand how dopamine pathways in the brain are disrupted after severe injury and how these changes relate to a patient’s recovery over time. Participants will be followed for up to one year, with assessments at 3 months, 6 months, and 1 year to track neurological recovery and quality of life.
Treatment being tested: The study uses [18F]LBT-999, a radiotracer injected into the bloodstream that helps visualize dopamine transporters during PET scans. This allows researchers to see which areas of the brain’s dopamine system are affected by the injury.
Study on the Effects of Ketamine on Therapy Intensity and Brain Pressure in Patients with Traumatic Brain Injury
This Belgian trial examines whether adding ketamine to standard sedation treatment can help reduce the intensity of treatments needed to manage pressure inside the skull after brain injury.
Who can participate: Adults aged 18 years and older who have been admitted to the intensive care unit with a brain injury are eligible. Participants must have a device in place to monitor intracranial pressure (pressure inside the skull), which must be inserted within 72 hours of hospital admission. They must also require sedation as part of their treatment.
Who cannot participate: The study does not specify detailed exclusion criteria beyond requiring participants to have a brain injury and meet the age and monitoring requirements.
What the study aims to do: The main goal is to determine whether ketamine can reduce the therapy intensity level needed to control brain pressure and decrease the number of episodes where brain pressure becomes dangerously high. The study will also track how long patients need sedation, their length of stay in intensive care and hospital, and their overall recovery at 6 months after injury.
Treatment being tested: Ketamine, delivered through intravenous infusion, is being tested as an addition to standard sedative treatments. Some participants will receive ketamine while others will receive a placebo (inactive substance) for comparison.
Study of Mesenchymal Stromal Cells Treatment for Patients with Traumatic Brain Injury: A Safety and Effectiveness Trial
This Italian study investigates whether stem cells, specifically mesenchymal stromal cells, can help reduce brain damage and improve recovery in patients with severe head injuries.
Who can participate: Adults aged 18-70 years who have suffered a severe brain injury visible on CT scan are eligible. Participants must be relatively fit before the injury (Clinical Frailty Index score less than 5), have a Glasgow Coma Scale score of 8 or lower with at least one pupil still reacting to light, and weigh between 40 and 100 kilograms. Treatment must be given within 48 hours after the injury occurs. Participants must already have or be scheduled to have a device monitoring brain pressure as part of their regular care.
Who cannot participate: People under 18 or over 65 years old, pregnant or breastfeeding women, those with previous brain injuries, active infections affecting the brain, known allergies to study medications, severe blood clotting disorders, cancer in the past 5 years, major psychiatric disorders, or active substance abuse are excluded. Those unable to provide informed consent (either directly or through a legal representative) or with conditions preventing follow-up visits cannot participate.
What the study aims to do: The trial aims to determine if stem cell treatment is safe and can reduce brain damage after severe injury. Researchers will monitor participants for one year using brain scans (MRI) and blood tests to measure markers of brain injury and inflammation. They will assess recovery progress and quality of life at 6 months and 12 months.
Treatment being tested: Participants will receive either mesenchymal stromal cells (at two different doses: 80 million or 160 million cells) or a placebo through a single infusion within 48 hours of injury. These cells have natural healing properties and may help repair damaged tissue and reduce inflammation.
Study on the Effects of Cerebrolysin and Sodium Chloride for Recovery in Patients with Moderate to Severe Traumatic Brain Injury
This Romanian trial tests whether Cerebrolysin, a medication believed to support nerve cell repair and growth, can improve recovery outcomes in people with moderate to severe brain injuries.
Who can participate: Adults aged 18-85 years with a Glasgow Coma Scale score between 7 and 12 (measured within 24 hours of hospital admission) are eligible. Participants must have isolated brain injury without significant injuries to other body areas, CT scan results classified from I to VI, and must have been fully active before the injury (Karnofsky Index of 100). They must be able to provide written consent, willing to follow study requirements, and must have been able to speak, read, and write before the injury. Women of childbearing age must have a negative pregnancy test and agree to use birth control. Treatment must begin within 4 hours of the injury.
Who cannot participate: People outside the specified age range, those from clinical trial groups not included in this study, and individuals considered part of vulnerable populations are excluded.
What the study aims to do: The trial evaluates whether Cerebrolysin can improve recovery after moderate to severe brain injury. Researchers will assess participants at multiple time points (10, 45, 90, and 180 days) to measure neurological function, symptoms of anxiety and depression, quality of life, and any side effects from the medication.
Treatment being tested: Cerebrolysin, given through intravenous infusion, is compared against a placebo. The medication is thought to promote neuroprotection and help the brain repair and regenerate by supporting nerve cell growth and survival.
Study on the Safety and Effectiveness of C1 Esterase Inhibitor and Sodium Chloride for Patients with Traumatic Brain Injury
This Dutch study examines whether C1 Esterase Inhibitor (also known as Cinryze) can reduce harmful inflammation after brain injury and improve patient outcomes.
Who can participate: Adults over 18 years old who have suffered a brain injury and have a Glasgow Coma Scale score of less than 13 are eligible. Participants must have a device in place to monitor intracranial pressure (pressure inside the skull).
Who cannot participate: People with a history of severe allergic reactions to the study medication, those currently participating in another clinical trial, individuals with uncontrolled medical conditions that could interfere with study results, pregnant or breastfeeding women, those with substance abuse in the past year, people who have had major surgery within the last 30 days, individuals with severe liver or kidney disease, and those with mental health conditions that could interfere with study participation are excluded.
What the study aims to do: The trial aims to understand how safe and effective C1 Esterase Inhibitor is in reducing excessive inflammation after brain injury. Researchers will monitor the therapy intensity level (how much treatment is needed) and track recovery progress to determine if the medication leads to better outcomes.
Treatment being tested: C1 Esterase Inhibitor (Cinryze), given through intravenous injection, works by blocking certain proteins in the body that cause inflammation. After brain injury, inflammation can become excessive and harmful, so this medication aims to control that response and potentially improve recovery.
Summary
These 6 clinical trials represent diverse approaches to understanding and treating craniocerebral injury across Europe. A notable pattern is that each country is conducting a distinct type of research, with no overlap in approaches between nations. The studies range from diagnostic imaging research (Sweden and France) to therapeutic interventions using medications (Belgium, Romania, and the Netherlands) and innovative cell-based therapies (Italy).
Two trials focus on advanced imaging techniques to better understand brain damage: one examining tau protein accumulation and another investigating dopamine system disruption. These studies aim to improve diagnostic understanding rather than test treatments. Four trials test actual interventions: ketamine for managing brain pressure, stem cells for tissue repair, Cerebrolysin for nerve cell support, and C1 Esterase Inhibitor for controlling inflammation.
Most trials focus on adults with severe injuries requiring intensive care, though the Swedish study uniquely includes athletes with persistent concussion symptoms. The timing of treatment administration varies significantly, from within 4 hours (Romanian trial) to within 48 hours (Italian trial), reflecting different therapeutic windows for various interventions. All studies emphasize careful monitoring and follow-up assessments, with some tracking patients for up to one year after injury to evaluate long-term recovery outcomes.