Chronic PainNCT06531837
Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury
A study testing Esketamine(Continuous infusion), Flurbiprofen (Single intravenous injection) and Spinal Cord Stimulation in people with Chronic Pain, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
The diagnosis of chronic pain currently lacks objective and quantifiable biomarkers. This study aims to observe the EEG characteristics of patients with chronic pain following spinal cord injury and subsequently administer analgesic interventions with remifentanil, esketamine, flurbiprofen, and spinal cord… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Esketamine(Continuous infusion), Flurbiprofen (Single intravenous injection) and Spinal Cord Stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2024to 28 Feb 2026
- 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;
- American Society of Anesthesiologists (ASA) I-III;
- Dextromanual;
- Chronic Pain following Spinal Cord Injury;
- Spinal cord electrical stimulator implantation under general anesthesia;
- Signed informed consent.
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- Age 18 - 65 years old;
- American Society of Anesthesiologists (ASA) I-III;
- Dextromanual;
- Spinal Cord Injury Patients Without Pain;
- Spinal cord electrical stimulator implantation under general anesthesia;
- Signed informed consent.
Who cannot join
- People with mental and behavioral disorders.
- Previous history of craniocerebral disease;
- History of drug and alcohol abuse;
- Patients with aphasia or inability to cooperate with the pain assessments;
- Previous adverse reaction to esketamine, opioids or NSAIDs;
- Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
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- Patients with myasthenia gravis, bronchial asthma, or a predisposition to respiratory depression;
- Bleeding tendency;
- BMI ≥ 35 kg/m²;
- Pregnancy or lactation.
- Spinal Cord Injury Patients Without Pain
- People with mental and behavioral disorders.
- Previous history of craniocerebral disease;
- History of drug and alcohol abuse;
- Patients with aphasia or inability to cooperate with the pain assessments;
- Previous adverse reaction to esketamine, opioids or NSAIDs;
- Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
- Patients with myasthenia gravis, bronchial asthma, or a predisposition to respiratory depression;
- Bleeding tendency;
- BMI ≥ 35 kg/m²;
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital
Beijing, 100070
Ruquan Han, M.D., Ph D., 8610-59976660, ruquan.han@ccmu.edu.cn
About this study
Official title: Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury: an Exploratory, Interventional, Non-randomized Controlled Study
The diagnosis of chronic pain currently lacks objective and quantifiable biomarkers. This study aims to observe the EEG characteristics of patients with chronic pain following spinal cord injury and subsequently administer analgesic interventions with remifentanil, esketamine, flurbiprofen, and spinal cord stimulation. The correlation between EEG features and pain intensity will be examined. The research aims to advance the objectification of chronic pain diagnosis and treatment.
- Conditions
- Chronic Pain
- Being tested
- Esketamine(Continuous infusion), Remifentanil (Target-Controlled Infusion), Flurbiprofen (Single intravenous injection), Spinal Cord Stimulation, No intervention
- Keywords
- Multichannel electroencephalogram, patients with spinal cord injury, Esketamine, Remifentanil, Flurbiprofen, Spinal cord stimulation
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine(Continuous infusion)Drug
Continuous intravenous infusion of esketamine at a dose of 0.2 mg/(kg · h). Collect resting-state EEG data and NRS scores 40 minutes after administration.
Remifentanil (Target-Controlled Infusion)Drug
The plasma drug concentrations of remifentanil were set at 0.5 ng/ml, 1 ng/ml, and 1.5 ng/ml. After each plasma drug concentration reached a steady state, the NRS scores were assessed, and resting-state EEG was recorded for at least 5 minutes.
Flurbiprofen (Single intravenous injection)Drug
Single intravenous injection of Flurbiprofen at a dose of 100 mg. Collect resting-state EEG data and NRS scores 10 minutes after administration.
Spinal Cord StimulationDevice
Collect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on.
No interventionOther
Collect resting-state EEG data and NRS scores.
| Study group | Role | What they receive |
|---|---|---|
| Patients without pain | Sham comparator | Not described Receives: Other: No intervention |
| Patients with chronic pain treated with esketamine | Experimental | Not described Receives: Drug: Esketamine(Continuous infusion); Device: Spinal Cord Stimulation |
| Patients with chronic pain treated with remifentanil | Experimental | Not described Receives: Drug: Remifentanil (Target-Controlled Infusion); Device: Spinal Cord Stimulation |
| Patients with chronic pain treated with flurbiprofen | Experimental | Not described Receives: Drug: Flurbiprofen (Single intravenous injection); Device: Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Spectral Characteristics
EEG power spectrum characteristics of chronic pain in patients with spinal cord injury under esketamine, remifentanil, flurbiprofen administration and spinal cord stimulation, including the δ, θ, α, β, and γ frequency bands.
administration, including the δ, θ, α, β, and γ frequency bands.
Measured: During the trial(up to 3 hours for each subject).
Secondary outcomes (3)
Numeric Rating Scale(NRS)
Numerical Rating Scale Assessment Pre- and Post-Analgesic Treatment. The NRS ranges from 0 to 10, with 0-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.
Measured: During the trial(through study completion, 7 days)
Generalized Anxiety Disorder(GAD-7)
The GAD-7 scale ranges from 0 to 21 points, with a higher score indicating a higher level of anxiety.
Measured: During the trial(through study completion, 7 days)
Patient Health Questionnaire-9(PHQ-9)
The PHQ-9 scale ranges from 0 to 27 points, with a higher score indicating a higher level of depression.
Measured: During the trial(through study completion, 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start25 Aug 2024 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- 60 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
- Investigators
- Ruquan Han, M.D., Ph D, Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531837
- Sponsor's protocol ID
- zz20240512
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury: an Exploratory, Interventional, Non-randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06531837
- Acronym / sponsor ID
- zz20240512
- Conditions
- Chronic Pain
- Keywords
- Multichannel electroencephalogram, patients with spinal cord injury, Esketamine, Remifentanil, Flurbiprofen, Spinal cord stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 25 Aug 2024 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 1 Aug 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.
The diagnosis of chronic pain currently lacks objective and quantifiable biomarkers. This study aims to observe the EEG characteristics of patients with chronic pain following spinal cord injury and subsequently administer analgesic interventions with remifentanil, esketamine, flurbiprofen, and spinal cord stimulation. The correlation between EEG features and pain intensity will be examined. The research aims to advance the objectification of chronic pain diagnosis and treatment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients without pain | Sham comparator | Other: No intervention |
| Patients with chronic pain treated with esketamine | Experimental | Drug: Esketamine(Continuous infusion), Device: Spinal Cord Stimulation |
| Patients with chronic pain treated with remifentanil | Experimental | Drug: Remifentanil (Target-Controlled Infusion), Device: Spinal Cord Stimulation |
| Patients with chronic pain treated with flurbiprofen | Experimental | Drug: Flurbiprofen (Single intravenous injection), Device: Spinal Cord Stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 - 65 years old;
- American Society of Anesthesiologists (ASA) I-III;
- Dextromanual;
- Chronic Pain following Spinal Cord Injury;
- Spinal cord electrical stimulator implantation under general anesthesia;
Key exclusion criteria (21 listed)
- People with mental and behavioral disorders.
- Previous history of craniocerebral disease;
- History of drug and alcohol abuse;
- Patients with aphasia or inability to cooperate with the pain assessments;
- Previous adverse reaction to esketamine, opioids or NSAIDs;
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 |
|---|---|---|
| Esketamine(Continuous infusion)Continuous intravenous infusion of esketamine at a dose of 0.2 mg/(kg · h). Collect resting-state EEG data and NRS scores 40 minutes after administration. | Drug | Patients with chronic pain treated with esketamine |
| Remifentanil (Target-Controlled Infusion)The plasma drug concentrations of remifentanil were set at 0.5 ng/ml, 1 ng/ml, and 1.5 ng/ml. After each plasma drug concentration reached a steady state, the NRS scores were assessed, and resting-state EEG was recorded for at least 5 minutes. | Drug | Patients with chronic pain treated with remifentanil |
| Flurbiprofen (Single intravenous injection)Single intravenous injection of Flurbiprofen at a dose of 100 mg. Collect resting-state EEG data and NRS scores 10 minutes after administration. | Drug | Patients with chronic pain treated with flurbiprofen |
| Spinal Cord StimulationCollect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on. | Device | Patients with chronic pain treated with esketamine, Patients with chronic pain treated with flurbiprofen, Patients with chronic pain treated with remifentanil |
| No interventionCollect resting-state EEG data and NRS scores. | Other | Patients without pain |
Primary outcome
EEG Spectral Characteristics
Time frame: During the trial(up to 3 hours for each subject).
EEG power spectrum characteristics of chronic pain in patients with spinal cord injury under esketamine, remifentanil, flurbiprofen administration and spinal cord stimulation, including the δ, θ, α, β, and γ frequency bands. administration, including the δ, θ, α, β, and γ frequency bands.
3 secondary outcomes
Numeric Rating Scale(NRS)
Time frame: During the trial(through study completion, 7 days)
Generalized Anxiety Disorder(GAD-7)
Time frame: During the trial(through study completion, 7 days)
Patient Health Questionnaire-9(PHQ-9)
Time frame: During the trial(through study completion, 7 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
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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.
Ruquan Han, M.D., Ph D study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine(Continuous infusion), Flurbiprofen (Single intravenous injection) and Spinal Cord Stimulation in people with Chronic Pain, 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 12 inclusion and 21 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 13 Aug 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. Some participants in this study may receive a placebo. 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?
Contact Ruquan Han, M.D., Ph D (8610-59976660, ruquan.han@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG Spectral Characteristics (time frame: During the trial(up to 3 hours for each subject).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2024.