Prolonged Disorders of ConsciousnessNCT06473285
Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Prolonged Disorders of Consciousness
A study testing Drug: Esketamine (Continuous infusion) in people with Prolonged Disorders of Consciousness, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prolonged Disorders of Consciousness
- What is being tested?
- Drug: Esketamine (Continuous infusion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years old, native Chinese speaker, dextromanual;
- Chronic disorder of consciousness;
- Spinal cord electrical stimulator implantation under general anesthesia;
- Signed informed consent.
- Age 18 - 65 years old;
- Patients undergoing surgical treatment under elective general anaesthesia;
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- American Society of Anesthesiologists (ASA) I-II;
- Native Chinese speaker;
- Dextromanual;
- Signed informed consent.
Who cannot join
- 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;
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- 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:
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100070
Ruquan Han, M.D., Ph.D, 8610-59976660, ruquan.han@gmail.com
Ruquan Han, M.D., Ph.D
About this study
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
- Being tested
- Drug: Esketamine (Continuous infusion)
- Keywords
- Esketamine, Multichannel electroencephalogram, Event-related potential, Brain network characteristics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy brain volunteers | Active comparator | Not described Receives: Drug: Drug: Esketamine (Continuous infusion) |
| Patients with prolonged disorders of consciousness | Experimental | Not described Receives: Drug: Drug: Esketamine (Continuous infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Entropy index.
A higher entropy index indicates a higher brain complexity.
Measured: During the trial(up to 3 hours for each subject).
Lempel Ziv complexity.
Higher Lempel Ziv complexity indicates higher brain complexity.
Measured: During the trial(up to 3 hours for each subject).
Secondary outcomes (3)
EEG Spectral Characteristics
EEG power spectrum characteristics of pDoC patients under esketamine. administration, including the δ, θ, α, β, and γ frequency bands.
Measured: During the trial(up to 3 hours for each subject).
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.
Measured: During the trial(up to 3 hours for each subject.
Rate of patients recovered consciousness after surgery
Rate of patients recovered consciousness 30 days, 90 days, 180 days after surgery.
Measured: During the trial(through study completion, 180 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jun 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prolonged Disorders of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473285
- Sponsor's protocol ID
- LY20240424
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liang Y, Yang W, Wang X, Ge Q, Wang J, Chen Y, Ma B, Jian M, Liu H, He J, Han R. Acute Effects of Esketamine on the EEG Power Spectrum and Signal Complexity in Prolonged Disorders of Consciousness: A Prospective Exploratory Cohort Study. J Neurosurg Anesthesiol. 2026 Jun 15. doi: 10.1097/ANA.0000000000001124. Online ahead of print.
PubMed 42290311
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Esketamine on Consciousness-related Brain Network Characteristics in Patients With Prolonged Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT06473285
- Acronym / sponsor ID
- LY20240424
- Conditions
- Prolonged Disorders of Consciousness
- Keywords
- Esketamine, Multichannel electroencephalogram, Event-related potential, Brain network characteristics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy brain volunteers | Active comparator | Drug: Drug: Esketamine (Continuous infusion) |
| Patients with prolonged disorders of consciousness | Experimental | Drug: Drug: Esketamine (Continuous infusion) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 - 65 years old, native Chinese speaker, dextromanual;
- Chronic disorder of consciousness;
- Spinal cord electrical stimulator implantation under general anesthesia;
- Signed informed consent.
- Age 18 - 65 years old;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Healthy brain volunteers, Patients with prolonged disorders of consciousness |
Primary outcome
Entropy index.
Time frame: During the trial(up to 3 hours for each subject).
A higher entropy index indicates a higher brain complexity.
Lempel Ziv complexity.
Time frame: During the trial(up to 3 hours for each subject).
Higher Lempel Ziv complexity indicates higher brain complexity.
3 secondary outcomes
EEG Spectral Characteristics
Time frame: During the trial(up to 3 hours for each subject).
Cortical Connectivity
Time frame: During the trial(up to 3 hours for each subject.
Rate of patients recovered consciousness after surgery
Time frame: During the trial(through study completion, 180 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 42290311Liang Y, Yang W, Wang X, Ge Q, Wang J, Chen Y, Ma B, Jian M, Liu H, He J, Han R. Acute Effects of Esketamine on the EEG Power Spectrum and Signal Complexity in Prolonged Disorders of Consciousness: A Prospective Exploratory Cohort Study. J Neurosurg Anesthesiol. 2026 Jun 15. doi: 10.1097/ANA.0000000000001124. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug: Esketamine (Continuous infusion) in people with Prolonged Disorders of Consciousness, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Entropy index. (time frame: During the trial(up to 3 hours for each subject).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.