CClinicalTrials.gg
Sign In
Not yet recruitingNCT06531837Updated Aug 13, 2024

Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury

An interventional study of Esketamine(Continuous infusion) and Remifentanil (Target-Controlled Infusion) in Chronic Pain, sponsored by Beijing Tiantan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-13.

Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Chronic Pain

Keywords

  • Multichannel electroencephalogram
  • patients with spinal cord injury
  • Esketamine
  • Remifentanil
  • Flurbiprofen
  • Spinal cord stimulation
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's planned enrollment of 60 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 281 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Spinal Cord Injury Patients With Chronic Pain

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Spinal Cord Injury Patients Without Pain

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Sham comparator
    Patients without pain

    Other: No intervention

  • Experimental
    Patients with chronic pain treated with esketamine

    Drug: Esketamine(Continuous infusion) · Device: Spinal Cord Stimulation

  • Experimental
    Patients with chronic pain treated with remifentanil

    Drug: Remifentanil (Target-Controlled Infusion) · Device: Spinal Cord Stimulation

  • Experimental
    Patients with chronic pain treated with flurbiprofen

    Drug: Flurbiprofen (Single intravenous injection) · Device: Spinal Cord Stimulation

Interventions

  • DrugEsketamine(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.

  • DrugRemifentanil (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.

  • DrugFlurbiprofen (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.

  • DeviceSpinal Cord Stimulation

    Collect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on.

  • OtherNo intervention

    Collect resting-state EEG data and NRS scores.

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

    Time frame: During the trial(through study completion, 7 days)

  2. 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.

    Time frame: During the trial(through study completion, 7 days)

  3. 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.

    Time frame: During the trial(through study completion, 7 days)

07

Study locations

1 site
  • Beijing Tiantan Hospital
    Beijing, 100070, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06531837
Lead sponsor
Beijing Tiantan Hospital
Responsible party
Ruquan Han (Professor, Beijing Tiantan Hospital) — Principal investigator
First posted
Aug 1, 2024
Start date
Aug 25, 2024 (estimated)
Primary completion
Jan 31, 2026 (estimated)
Completion
Feb 28, 2026 (estimated)
Last update
Aug 13, 2024

Study contacts

Ruquan Han, M.D., Ph D
Contact
ruquan.han@ccmu.edu.cn
8610-59976660
Ruquan Han, M.D., Ph D
study chair · Beijing Tiantan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Spinal Cord Injuries→

Other studies from this sponsor

Beijing Tiantan Hospital

Start the discussion