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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tiantan Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age 18 - 65 years old, native Chinese speaker, dextromanual;

Chronic disorder of consciousness;

Spinal cord electrical stimulator implantation under general anesthesia;

Signed informed consent.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Healthy brain volunteersActive comparator 1 intervention
Group B: Patients with prolonged disorders of consciousnessExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Entropy index.

A higher entropy index indicates a higher brain complexity.

Time frame
During the trial(up to 3 hours for each subject).
2

Lempel Ziv complexity.

Higher Lempel Ziv complexity indicates higher brain complexity.

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

Secondary outcomes

1

EEG Spectral Characteristics

EEG power spectrum characteristics of pDoC patients under esketamine. administration, including the δ, θ, α, β, and γ frequency bands.

Time frame
During the trial(up to 3 hours for each subject).
2

Cortical Connectivity

Characteristics of the weighted phase lag index(WPLI) in patients with pDoC. 0 ≤ WPLI ≤ 1, where 0 represents asynchronous and 1 represents synchronous.

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

Rate of patients recovered consciousness after surgery

Rate of patients recovered consciousness 30 days, 90 days, 180 days after surgery.

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

Other outcomes

Sponsors and contacts

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