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NCT Number: NCT06531837

Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 Stimulation

Device

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

No intervention

Other

Collect resting-state EEG data and NRS scores.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Numeric Rating Scale(NRS)

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

    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.

  2. Generalized Anxiety Disorder(GAD-7)

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

    The GAD-7 scale ranges from 0 to 21 points, with a higher score indicating a higher level of anxiety.

  3. Patient Health Questionnaire-9(PHQ-9)

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

    The PHQ-9 scale ranges from 0 to 27 points, with a higher score indicating a higher level of depression.

Study contacts

Contact information is provided by the study sponsor or research team.

Ruquan Han, M.D., Ph D

CONTACT

[email protected]

8610-59976660

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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