Clinical trial NCT06473285: Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Prolonged Disorders of Consciousness
Official title: Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Prolonged Disorders of Consciousness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prolonged Disorders of Consciousness
Keywords: Esketamine
Multichannel electroencephalogram
Event-related potential
Brain network characteristics
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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 mental and behavioral disorders.

Primary outcomes:
measure: Entropy index.
timeFrame: During the trial(up to 3 hours for each subject).
measure: Lempel Ziv complexity.
timeFrame: During the trial(up to 3 hours for each subject).
Secondary outcomes:
measure: EEG Spectral Characteristics
timeFrame: During the trial(up to 3 hours for each subject).
measure: Cortical Connectivity
timeFrame: During the trial(up to 3 hours for each subject.
measure: Rate of patients recovered consciousness after surgery
timeFrame: During the trial(through study completion, 180 days).
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
References: