NCT06473285

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Drug: Esketamine (Continuous infusion)	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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2024-06-25
• Last updated: 2024-06-25

Locations

1 site across 1 country: China