Clinical trial NCT06531837: Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury
Official title: Electroencephalographic Characteristics of Chronic Pain in Patients With Spinal Cord Injury: an Exploratory, Interventional, Non-randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Multichannel electroencephalogram
patients with spinal cord injury
Esketamine
Remifentanil
Flurbiprofen
Spinal cord stimulation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: EEG Spectral Characteristics
timeFrame: During the trial(up to 3 hours for each subject).
Secondary outcomes:
measure: Numeric Rating Scale(NRS)
timeFrame: During the trial(through study completion, 7 days)
measure: Generalized Anxiety Disorder(GAD-7)
timeFrame: During the trial(through study completion, 7 days)
measure: Patient Health Questionnaire-9(PHQ-9)
timeFrame: During the trial(through study completion, 7 days)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ruquan Han, M.D., Ph D
role: STUDY_CHAIR
References: