Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury

NCT06531837 | Not Yet Recruiting

• 1 other identifier: zz20240512
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Keywords

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

Outcome Measures

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.

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

Secondary Outcomes (3)

• Numeric Rating Scale(NRS)

  During the trial(through study completion, 7 days)

• Generalized Anxiety Disorder(GAD-7)

  During the trial(through study completion, 7 days)

• Patient Health Questionnaire-9(PHQ-9)

  During the trial(through study completion, 7 days)

Study Arms (4)

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

Interventions

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.

Patients with chronic pain treated with esketamine

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.

Patients with chronic pain treated with remifentanil

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.

Patients with chronic pain treated with flurbiprofen

Spinal Cord Stimulation DEVICE

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

Patients with chronic pain treated with esketamine; Patients with chronic pain treated with flurbiprofen; Patients with chronic pain treated with remifentanil

No intervention OTHER

Collect resting-state EEG data and NRS scores.

Patients without pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Age 18 - 65 years old;
• American Society of Anesthesiologists (ASA) I-III;
• Dextromanual;
• Spinal Cord Injury Patients Without Pain;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Remifentanil; Flurbiprofen; Injections, Intravenous; Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Injections; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation

Study Officials

• Ruquan Han, M.D., Ph D

  Beijing Tiantan Hospital

  STUDY CHAIR

Central Study Contacts

Ruquan Han, M.D., Ph D

CONTACT

8610-59976660; ruquan.han@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: August 25, 2024
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

CN (1)