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Not yet recruiting NCT06531837

Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury

No phase Interventional Chronic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Esketamine(Continuous infusion), Remifentanil (Target-Controlled Infusion), Flurbiprofen (Single intravenous injection), Spinal Cord Stimulation.
Who it may be relevant to
Registry conditions: Chronic Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury: an Exploratory, Interventional, Non-randomized Controlled Study

Overview

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.

Interventions

  • Drug 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 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 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.
  • Device Spinal Cord Stimulation
    Collect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on.
  • Other No intervention
    Collect resting-state EEG data and NRS scores.

Primary outcome measures

  • EEG Spectral Characteristics [Time frame: During the trial(up to 3 hours for each subject).]
Secondary outcome measures (3)
  • 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT06531837 · zz20240512

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗