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Study on the Effects of Dexmedetomidine on Brain Fluid Flow and Activity in Patients with Neurodegenerative Diseases, Delirium, or Acute Neurological Conditions

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Dexmedetomidine on the brain. The diseases being studied include neurodegenerative disease, delirium, and acute neurological disease. The purpose of the study is to understand how this medication influences brain functions such as blood flow and the movement of cerebrospinal fluid, which is a clear liquid surrounding the brain and spinal cord. The study will use a technique called functional Magnetic Resonance Imaging (MRI) to observe these effects.

Participants in the study will receive Dexmedetomidine through an intravenous infusion, which means it will be administered directly into a vein. The study will observe changes in brain activity and blood flow while participants are awake and under different levels of sedation caused by the medication. The study will also use electroencephalography (EEG), a method to record electrical activity of the brain, to gather more information about how the brain functions during these different states.

The study aims to gather data on how Dexmedetomidine affects brain signals and other bodily functions, such as blood pressure and heart rate. This information will help researchers understand the potential benefits and effects of the medication on brain health, particularly in relation to the diseases being studied. The study will also look at how the medication affects various biomarkers, which are substances in the body that can indicate how well the body is functioning or responding to treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on criteria such as age, health status, and other factors.
You will undergo a series of tests to ensure you meet the study requirements, including a check of your heart's electrical activity (ECG), blood pressure, and oxygen levels in your blood (SpO2).
Step 2
Baseline measurements
Before starting the medication, baseline measurements will be taken. This includes a functional magnetic resonance imaging (MRI) scan to assess brain activity, blood flow, and cerebrospinal fluid (CSF) flow.
An electroencephalography (EEG) test will also be conducted to measure electrical activity in your brain.
Step 3
Medication administration
You will receive a medication called dexmedetomidine through an intravenous (IV) line. This means the medication will be given directly into your bloodstream.
The dosage and frequency will be determined by the study team, and you will be monitored closely during this time.
Step 4
Monitoring and assessments
While under the influence of the medication, additional MRI and EEG tests will be conducted to observe changes in brain activity, blood flow, and CSF flow.
Blood samples will be taken to measure various biomarkers, which are substances in your blood that can provide information about your health and how your body is responding to the medication.
Step 5
Follow-up visit
After the medication effects have worn off, a follow-up visit will be scheduled. During this visit, further assessments may be conducted to ensure your well-being.
Any changes in your health or side effects experienced will be discussed with the study team.

Who can join the trial?

11 criteria

Must be able to speak Finnish fluently.
Head size should not be larger than 59 cm in circumference.
Must be right-handed.
Age should be between 18 and 45 years.
Must be healthy, meaning no current illnesses.
Must have a normal ECG (electrocardiogram), which is a test that checks for problems with the electrical activity of your heart.
Must have normal blood pressure, which means the force of your blood against your artery walls is within a healthy range.
Must have normal SpO2, which is a measure of the oxygen level in your blood.
Must not show any signs of substance abuse, meaning no misuse of drugs or alcohol.
Must have acceptable values in laboratory tests, which means blood and other tests show normal results.
Must have a normal weight, with a BMI (Body Mass Index) between 18.5 and 30 kg/m².

Who cannot join the trial?

3 criteria

Patients with a **neurodegenerative disease** cannot participate. This refers to conditions where the brain and nerves gradually worsen over time.
Patients experiencing **delirium** are excluded. Delirium is a sudden change in mental state that causes confusion and reduced awareness of the environment.
Patients with an **acute neurological disease** are not eligible. This means any sudden and severe condition affecting the nervous system, which includes the brain and spinal cord.

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Helsinki University Central Hospital
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Helsinki, Finland

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Investigated drugs

Dexmedetomidine is a medication used in this study to help understand how it affects the brain's functions. It is often used to make people feel calm and sleepy, which is known as sedation. In this trial, researchers are looking at how dexmedetomidine changes the flow of fluids in the brain, the brain's blood flow, and the brain's activity when people are awake and when they are sedated. This helps scientists learn more about how the brain works in different states of consciousness.

Dexmedetomidine

What is already known about the treatment

Dexmedetomidine – Dexmedetomidine is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently being studied for its effects on brain functions, particularly in how it influences brain fluid flow and activity during different levels of sedation. This medication is primarily used for its calming effects in patients with neurodegenerative diseases, delirium, and acute neurological conditions. At the molecular level, dexmedetomidine works by activating certain receptors in the brain called alpha-2 adrenergic receptors, which help to reduce nerve activity and promote relaxation. It is classified as a sedative and is often used in medical settings to help patients remain calm and comfortable.

Investigated diseases

Neurodegenerative disease
Neurodegenerative diseases involve the progressive degeneration of the structure and function of the nervous system. These diseases are characterized by the gradual loss of neurons, which are the building blocks of the nervous system. As the disease progresses, it can lead to a decline in cognitive abilities, motor skills, and other functions controlled by the nervous system. The progression can vary widely depending on the specific type of neurodegenerative disease. Common examples include Alzheimer's disease, Parkinson's disease, and amyotrophic lateral sclerosis (ALS). The exact cause of neuron degeneration in these diseases is often unknown, but it may involve genetic, environmental, and lifestyle factors.
Delirium
Delirium is a sudden change in mental status that results in confusion, disorientation, and difficulty with attention and awareness. It typically develops over a short period, such as hours or days, and can fluctuate throughout the day. The condition is often temporary and can be triggered by various factors, including infections, medications, or surgery. As delirium progresses, individuals may experience hallucinations, restlessness, and mood swings. It is more common in older adults and those with pre-existing cognitive impairments. Identifying and addressing the underlying cause is crucial for managing delirium.
Acute neurological disease
Acute neurological diseases are conditions that affect the nervous system and develop rapidly, often requiring immediate medical attention. These diseases can impact the brain, spinal cord, or peripheral nerves, leading to sudden symptoms such as severe headaches, seizures, or loss of consciousness. The progression of acute neurological diseases can vary, with some conditions resolving quickly and others leading to more prolonged effects. Causes can include infections, trauma, or vascular events like strokes. Early recognition and intervention are essential to prevent further complications and support recovery.