Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Pro… (NCT06473285) | Clinical Trial Compass
UnknownNot Applicable
Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Prolonged Disorders of Consciousness
China80 participantsStarted 2024-06-01
Plain-language summary
Prolonged disorders of consciousness (pDoC) are pathologies in which there is a loss of consciousness for more than 28 days. The number of patients with pDoC is increasing as the level of critical care treatment and monitoring improves. However, clinical trials for patients with pDoC are limited by small sample sizes, lack of placebo groups, and use of heterogeneous outcome measures. As a result, few therapies have strong evidence to support their use. In recent years, ketamine has been used with remarkable success in the treatment of neuropsychiatric disorders by inducing neuroplasticity, increasing neurophysiologic complexity, and expanding functional brain connectivity states. Considering increased brain plasticity as well as brain complexity, it may be beneficial for consciousness recovery. In this study, the investigators aimed to explore the effects of esketamine on brain networks and level of consciousness in patients with pDoC, and to discuss its possible use as a wakefulness-promoting treatment for patients with pDoC.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Patients with prolonged disorders of consciousness:
Inclusion Criteria:
* Age 18 - 65 years old, native Chinese speaker, dextromanual;
* Chronic disorder of consciousness;
* Spinal cord electrical stimulator implantation under general anesthesia;
* Signed informed consent.
Exclusion Criteria:
* Continuous sedation was administered within 72 hours prior to the study;
* Open head injury, parenchymal resection and other damage of brain structural integrity;
* The intracranial compliance decreased due to hydrocephalus and swelling;
* Known hearing impairment;
* Airway stenosis and various causes of severe ventilation or ventilation dysfunction;
* Known or suspected severe cardiac, pulmonary, hepatic, and renal dysfunction;
* History of drug allergy to esketamine;
* Associated with other mental or neurological diseases;
* Other reasons are not suitable to participate in this study.
Healthy brain volunteers:
Inclusion Criteria:
* Age 18 - 65 years old;
* Patients undergoing surgical treatment under elective general anaesthesia;
* American Society of Anesthesiologists (ASA) I-II;
* Native Chinese speaker;
* Dextromanual;
* Signed informed consent.
Exclusion Criteria:
* Previous history of craniocerebral disease, imaging suggests organic brain lesions;
* People with uncontrolled hypertension, hyperthyroidism, elevated intracranial pressure, epileptic seizures;
* History of drug allergy to esketamine;
* Hearing abnormality;
* History of drug and alcohol abuse;
* People with m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Entropy index.
Timeframe: During the trial(up to 3 hours for each subject).
2
Lempel Ziv complexity.
Timeframe: During the trial(up to 3 hours for each subject).