Study on Dopaminergic Pathway Disruption in Comatose Patients with Traumatic Brain Injury Using [18F]LBT-999

4 1 1

What is this study about?

This clinical trial is focused on studying the effects of severe Traumatic Brain Injury (TBI) that leads to a coma. The study aims to understand how this type of injury affects the brain’s dopaminergic pathways, which are involved in the production and regulation of dopamine, a chemical that plays a key role in brain function. The trial uses a special imaging agent called [18F]LBT-999, which is a solution for injection. This agent helps to visualize the brain’s dopamine transporters during a type of brain scan known as a PET scan.

The purpose of the study is to explore the metabolic changes in the brain’s dopamine network in patients who have experienced a traumatic coma. Participants will receive the [18F]LBT-999 injection, and then undergo a PET scan to observe how the agent binds to dopamine transporters in the brain. This will help researchers compare the brain activity of patients with traumatic coma to those without such injuries. The study will also look at how these changes relate to the patient’s recovery and overall brain function over time.

Throughout the study, participants will be monitored at different intervals, including 3 months, 6 months, and 1 year after the initial brain injury. This will help assess their neurological recovery and quality of life. The study aims to provide valuable insights into the recovery process of patients with severe traumatic brain injuries and potentially improve future treatment approaches.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, social security affiliation, and obtaining informed consent. For patients, a trusted person may provide consent if necessary.

Eligibility criteria include being between 18 and 65 years old, having experienced a non-penetrating traumatic brain injury (TBI) within the last 30 days, and showing clinical stability without the need for specific management that would prevent medical transfer.

2 discontinuation of sedatives

Patients must have discontinued sedative treatments for more than 48 hours before participating in the trial. This ensures that the effects of sedatives do not interfere with the study results.

3 clinical stability check

A check for clinical stability is performed to ensure there is no hemodynamic, respiratory, or metabolic failure that would contraindicate a medical transfer to the imaging center.

4 imaging procedures

The study involves the use of a radiotracer called [18F]LBT-999, which is administered as a solution for injection through an intravenous route.

Positron Emission Tomography (PET) scans are conducted to assess the binding of the radiotracer to dopamine transporters in the brain. This helps in characterizing metabolic abnormalities in the dopaminergic network.

5 follow-up assessments

Neurological outcomes are assessed at 3 months, 6 months, and 1 year after the initial imaging procedures. This includes evaluations using the Coma Recovery Scale-Revised (CRS-R) and the Disability Rating Scale (DRS).

Quality of life is also assessed using the Quality of Life after Brain Injury (QOLIBRI) scale.

Who Can Join the Study?

Participants must be female or male and between 18 and 65 years old.
Participants must be part of a social security scheme or be a beneficiary of such a scheme.
Informed consent must be signed by the participant or by a trusted person if the participant is unable to do so. Informed consent means agreeing to participate in the study after understanding all the details.
Participants must be patients who have been admitted to the hospital due to a non-penetrating traumatic brain injury (TBI) that happened less than 30 days ago. This means the injury did not break through the skull.
Participants must have experienced a traumatic coma upon hospital admission, which is a state of deep unconsciousness. This is measured by a Glasgow Coma Scale (GCS) score of less than 10, with a motor score (M) of less than 6. The GCS is a scale used to assess consciousness after a brain injury.
Sedative treatments must have been stopped for more than 48 hours. Sedatives are medications that make you calm or sleepy.
Participants must be clinically stable, meaning they do not have any heart, breathing, or metabolic problems that need special treatment and would prevent them from being safely moved to the imaging center.
For the TC-COMA group: Participants must have a severe TBI with a prolonged loss of consciousness (coma), defined by an initial GCS score of less than 8 and a motor score of less than 6, without regaining consciousness (GCS less than 10 with M less than 6) on the day of inclusion.
For the severe TC-ROS group: Participants must have a severe TBI with a prolonged loss of consciousness (coma), defined by an initial GCS score of less than 8 and a motor score of less than 6, but have shown signs of regaining consciousness, such as responding to simple commands (GCS 10 or more with M equal to 6).
For control subjects: Participants must be matched in age (plus or minus 2 years) and sex to patients in the TC-COMA group.

Who Cannot Join the Study?

Patients who are not in a coma due to a severe traumatic brain injury cannot participate. A coma is a state of deep unconsciousness where a person cannot be awakened.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country	Status
Itcfoa Uzwchle &vbxqtq Tfmgnfmn Nmrunzmzluuvl Ckrjwn	Toulouse	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.04.2024

Trial locations

[18F]LBT-999 is a special type of imaging agent used in this clinical trial. It helps doctors see how the brain is working by highlighting certain areas when scanned. In this study, it is used to look at the brain’s dopamine system in patients who have had a severe brain injury and are in a coma. This imaging agent helps researchers understand how the brain’s dopamine pathways are affected by the injury and how they might recover over time. By using this agent, doctors can get a clearer picture of the brain’s activity and potentially find ways to help patients recover better from their injuries.

Traumatic Brain Injury – Traumatic Brain Injury (TBI) occurs when an external force injures the brain, often due to falls, vehicle accidents, or violence. The injury can lead to a range of physical and cognitive impairments, depending on the severity and location of the damage. In severe cases, TBI can result in a comatose state, where the patient is unconscious and unresponsive to external stimuli. The progression of TBI involves initial damage at the moment of impact, followed by secondary processes such as inflammation and swelling that can exacerbate the injury. Over time, patients may experience changes in brain function, including difficulties with movement, memory, and emotional regulation. Recovery varies widely, with some individuals regaining significant function while others may have lasting impairments.

Trial ID:

2023-504893-39-00

Protocol code:

C22-62

Trial Phase:

Therapeutic use (Phase IV)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Dopaminergic Pathway Disruption in Comatose Patients with Traumatic Brain Injury Using [18F]LBT-999

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?