Effects of Esketamine on Brain Network Characteristics in Patients with Prolonged Disorders of Consciousness

Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Prolonged Disorders of Consciousness

This study is testing if esketamine can help improve brain function and consciousness in patients with prolonged disorders of consciousness.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT06473285 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of esketamine on brain networks and consciousness levels in patients suffering from prolonged disorders of consciousness (pDoC). The research aims to explore how esketamine, known for its neuroplasticity-enhancing properties, can potentially aid in the recovery of consciousness in these patients. By utilizing multichannel electroencephalogram and event-related potentials, the study seeks to provide insights into the brain's functional connectivity and complexity. The findings may contribute to developing effective therapies for pDoC, a condition with limited treatment options.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 18 to 65 with chronic disorders of consciousness who have undergone spinal cord electrical stimulator implantation.

Not a fit: Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction, or those with a history of drug allergy to esketamine may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new therapeutic approaches for improving consciousness recovery in patients with prolonged disorders of consciousness.

How similar studies have performed: While there is limited research specifically on esketamine for pDoC, the use of ketamine in neuropsychiatric disorders has shown promising results, suggesting potential for success in this novel application.

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.

Where this trial is running

Beijing

• Beijing Tiantan Hospital, Capital Medical University — Beijing, China (Recruiting)

Conditions Prolonged Disorders of Consciousness; Esketamine; Multichannel electroencephalogram; Event-related potential; Brain network characteristics