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

NCT06473285 | Recruiting DMC

• 1 other identifier: LY20240424
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Prolonged Disorders of Consciousness

Keywords

Esketamine; Multichannel electroencephalogram; Event-related potential; Brain network characteristics

Outcome Measures

Primary Outcomes (2)

• Entropy index.

  A higher entropy index indicates a higher brain complexity.

  During the trial(up to 3 hours for each subject).

• Lempel Ziv complexity.

  Higher Lempel Ziv complexity indicates higher brain complexity.

  During the trial(up to 3 hours for each subject).

Secondary Outcomes (3)

• EEG Spectral Characteristics

  During the trial(up to 3 hours for each subject).

• Cortical Connectivity

  During the trial(up to 3 hours for each subject.

• Rate of patients recovered consciousness after surgery

  During the trial(through study completion, 180 days).

Study Arms (2)

Healthy brain volunteers

ACTIVE COMPARATOR

Drug: Drug: Esketamine (Continuous infusion)

Patients with prolonged disorders of consciousness

EXPERIMENTAL

Drug: Drug: Esketamine (Continuous infusion)

Interventions

Drug: Esketamine (Continuous infusion) DRUG

Continuous intravenous infusion of ketamine at a dose of 0.3mg/(kg · h). Collect resting state EEG and auditory event-related potential (ERP) before administration (baseline), 60 minutes after administration, 30 and 60 minutes after discontinuation.

Healthy brain volunteers; Patients with prolonged disorders of consciousness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 65 years old, native Chinese speaker, dextromanual;
• Chronic disorder of consciousness;
• Spinal cord electrical stimulator implantation under general anesthesia;
• Signed informed consent.

You may not qualify if:

• 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:
• Age 18 - 65 years old;
• Patients undergoing surgical treatment under elective general anaesthesia;
• American Society of Anesthesiologists (ASA) I-II;
• Native Chinese speaker;
• Dextromanual;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

RECRUITING

MeSH Terms

Interventions

Esketamine

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of anesthesiology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 25, 2024
• Study Start: June 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

CN (1)