Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Other: No intervention; Drug: Esketamine(Continuous infusion); Device: Spinal Cord Stimulation; Drug: Remifentanil (Target-Controlled Infusion); Drug: Flurbiprofen (Single intravenous injection)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruquan Han, M.D., Ph D; Phone Number: 8610-59976660; Email: ruquan.han@ccmu.edu.cn

Study Locations

• China
  • Beijing, China, 100070
    • Beijing Tiantan Hospital
    • Contact: Ruquan Han, M.D., Ph D.; Phone Number: 8610-59976660; Email: ruquan.han@ccmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Patients without pain	Other: No intervention; Collect resting-state EEG data and NRS scores.
Experimental: Patients with chronic pain treated with esketamine	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.; Device: Spinal Cord Stimulation; Collect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on.
Experimental: Patients with chronic pain treated with remifentanil	Device: Spinal Cord Stimulation; Collect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on.; 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.
Experimental: Patients with chronic pain treated with flurbiprofen	Device: Spinal Cord Stimulation; Collect resting-state EEG data and NRS scores with the spinal cord stimulator both turned off and on.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the trial(up to 3 hours for each subject).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	During the trial(through study completion, 7 days)

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Study Chair: Ruquan Han, M.D., Ph D, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 25, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Remifentanil; Esketamine; Spinal cord stimulation; Flurbiprofen; Multichannel electroencephalogram; patients with spinal cord injury
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Chronic Pain; Spinal Cord Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Antidepressive Agents; Remifentanil; Esketamine; Flurbiprofen
• Other Study ID Numbers: zz20240512

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No