Study on Ketamine for Treating Patients with Severe Brain Injury and Disorders of Consciousness

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What is this study about?

This clinical trial is focused on treating patients with disorders of consciousness, which can occur after a severe brain injury. These disorders can include conditions where a person is awake but not aware of themselves or their surroundings. The study is investigating the use of a medication called Ketalar, which contains the active ingredient ketamine. Ketamine is administered as a solution for injection or infusion, meaning it is given directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective ketamine is in improving consciousness in patients who have experienced a coma. The trial will compare the effects of ketamine to a placebo, which is a substance with no active medication. Participants will receive the treatment through an intravenous infusion, which is a method of delivering fluids directly into a vein. The study will monitor any new signs of consciousness, such as the ability to respond to commands, and will also assess changes in brain activity.

Throughout the study, researchers will use various methods to measure brain activity and other physical responses. These methods include fMRI (functional magnetic resonance imaging), which looks at brain activity by detecting changes in blood flow, and EEG (electroencephalogram), which records electrical activity in the brain. The study aims to understand how ketamine affects brain complexity and connectivity, which are important for consciousness. The trial is expected to continue until 2027, providing valuable insights into the potential benefits of ketamine for patients with disorders of consciousness.

1 joining the study

Upon joining the study, the patient must meet specific criteria, including being over 18 years old, clinically stable, and not dependent on medical ventilators for breathing.

The patient must have a diagnosis related to disorders of consciousness, such as unresponsive wakefulness syndrome or a minimally conscious state, confirmed by standardized assessments.

The patient must be more than 28 days post-injury, and informed consent must be obtained from a legal representative.

2 initial assessment

An initial assessment is conducted to establish a baseline for the patient’s condition. This includes behavioral assessments using the Simplified Evaluation of Consciousness Disorders (SECONDs).

Additional tests may include brain imaging techniques like fMRI and PET scans to evaluate brain activity and metabolism.

3 treatment phase

The treatment involves the administration of ketamine through intravenous infusion. The specific product used is Ketalar 10mg/ml Solution for Injection/Infusion.

The dosage and frequency of ketamine administration are determined by the study protocol, aiming to assess its effectiveness in improving consciousness.

4 monitoring and evaluation

Throughout the treatment phase, the patient’s response to ketamine is closely monitored. This includes observing any new signs of consciousness, such as responses to commands.

Brain complexity is measured using specific techniques during the ketamine sessions, comparing results to placebo and baseline measurements.

5 secondary assessments

Secondary assessments may include measuring spasticity using the Modified Ashworth Score and EMG recordings, as well as evaluating the range of motion.

EEG tests may be conducted to assess alpha connectivity in the brain.

6 conclusion of participation

The study is estimated to conclude by March 1, 2027. At the end of the study, a final assessment is conducted to evaluate the overall impact of the treatment on the patient’s condition.

Who Can Join the Study?

Must be more than 18 years old.
Must be clinically stable, meaning the patient’s condition is not changing rapidly, and not dependent on medical ventilators for breathing.
Must be diagnosed with one of the following conditions: unresponsive wakefulness syndrome (a state where a person is awake but not aware), minimally conscious state (a condition where there is minimal but definite awareness), or emerging from the minimally conscious state. This diagnosis should be based on at least two standardized tests called the Simplified Evaluation of Consciousness Disorders (SECONDs).
Must be more than 28 days after the initial brain injury or event that caused the condition.
Must have informed consent provided by a legal representative, meaning someone legally authorized to make decisions for the patient agrees to their participation in the study.

Who Cannot Join the Study?

Patients who have a severe brain injury that affects their consciousness. This means they have a serious injury to the brain that makes it hard for them to be fully aware or awake.
Patients who are not in the age range specified for the study. The study has certain age limits, and if a patient is too young or too old, they cannot participate.
Patients who do not fit into the specific group the study is looking for. The study is looking for certain types of patients, and if someone does not match, they cannot join.
Patients who are not able to give their own consent or are considered a vulnerable population. This means they might not fully understand the study or are in a situation where they need extra protection.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre hospitalier universitaire de Liege	Liege	Belgium
Ciywfb Nfoxbaluuduy Wrvlpfm Lpjfqu	Ottignies	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	01.01.2022

Trial locations

Investigated drugs:

Ketamine is a medication being studied for its potential to help patients with disorders of consciousness, which can occur after a coma. In this trial, ketamine is given through an intravenous infusion, meaning it is delivered directly into the bloodstream. The goal is to see if ketamine can improve the condition of patients by enhancing their consciousness levels. Researchers are also looking to find out how many patients respond positively to this treatment.

Investigated diseases:

Brain injury

Disorder of Consciousness – This condition involves a significant impairment in awareness and responsiveness, often resulting from severe brain injury. Individuals with this disorder may experience varying levels of consciousness, ranging from a complete lack of awareness to minimal consciousness. The progression can include periods of improvement or deterioration, with some patients showing signs of increased awareness over time. The condition is often associated with damage to specific brain areas responsible for consciousness and cognitive functions. It can manifest as a vegetative state or minimally conscious state, depending on the level of awareness and interaction with the environment.

Trial ID:

2024-518433-29-00

Protocol code:

V1ComplexitDOC

NCT ID:

NCT05343507

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Ketamine for Treating Patients with Severe Brain Injury and Disorders of Consciousness

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?