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Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Prolonged Disorders of Consciousness
Led by Beijing Tiantan Hospital · Updated on 2024-06-25
80
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Prolonged Disorders of Consciousness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years old
- Native Chinese speaker
- Right-handed (dextromanual)
- Chronic disorder of consciousness
- Spinal cord electrical stimulator implantation under general anesthesia
- Signed informed consent
- Age 18 to 65 years old (healthy brain volunteers)
- Undergoing surgical treatment under elective general anesthesia (healthy brain volunteers)
- American Society of Anesthesiologists (ASA) I-II (healthy brain volunteers)
- Signed informed consent (healthy brain volunteers)
You will not qualify if you...
- Continuous sedation within 72 hours before the study
- Open head injury or brain structural damage
- Decreased intracranial compliance due to hydrocephalus or swelling
- Known hearing impairment
- Airway stenosis or severe ventilation dysfunction
- Severe cardiac, pulmonary, hepatic, or renal dysfunction
- History of allergy to esketamine
- Other mental or neurological diseases
- Previous craniocerebral disease or organic brain lesion (healthy brain volunteers)
- Uncontrolled hypertension, hyperthyroidism, elevated intracranial pressure, or seizures (healthy brain volunteers)
- Hearing abnormalities (healthy brain volunteers)
- History of drug or alcohol abuse (healthy brain volunteers)
- Mental and behavioral disorders (healthy brain volunteers)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, China, 100070
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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