Clinical trial NCT06290024: A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data
Official title: A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data on Patients' Brain Physiology and Cognitive Function
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Patients who are in poor condition and cannot objectively describe their symptoms or complete the questionnaire score;
2. People with severe mental system, respiratory system, cardiovascular system diseases, liver and kidney insufficiency, malignant tumors;
3. Lactation, pregnant women, or subjects with pregnancy plans within 1 month after the trial (including male subjects);
4. People with allergic diseases and allergic constitution;
5. People with infected or damaged skin at the EEG collection site;
6. Have a history of drug abuse or drug addiction;

Brief summary: A multi-center clinical longitudinal study of neuropathic pain by collecting data on patients' brain physiology and cognitive function

Detailed description: Using the use of pain visual analog scale (VAS), digital pain grading method (NRS), neuropathic pain assessment scale (DN4), sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale), social support assessment scale (SSQ), Montreal cognitive assessment scale (MoCA), Barrett impulse scale (BIS), anxiety and depression score (GAD-7, PHQ-9), emotional tasks, cognitive function (N-back, time perception, delay-discount), electroencephalogram (EEG), near-infrared brain function imaging (fNIRS) and other indicators to study the dynamic changes of various factors in the process of acute pain.

Eligibility criteria: Inclusion Criteria:

1. The subjects voluntarily participated in the study and signed an informed consent form;
2. The age is between 18 years old (inclusive) and 85 years old (inclusive), regardless of gender;
3. Body mass index (BMI) ≤ 45;
4. Clinically clearly diagnosed neuropathological pain (pain VAS score ≥4 or above);
5. Did not participate in the drug/medical device test within 3 months before the test;

Exclusion Criteria:

-

Primary outcomes:
measure: Visual Analogue Scale/Score（VAS）
timeFrame: 1 month
measure: digital pain grading method (NRS)
timeFrame: 1 month
measure: neuropathic pain assessment scale (DN4)
timeFrame: 1 month
measure: sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale)
timeFrame: 1 month
measure: EEG
timeFrame: 1 month
measure: Barrett impulse scale (BIS)
timeFrame: 1 month
measure: (Generalized Anxiety Disorder,GAD-7)
timeFrame: 1 month
measure: (Patient Health Questionnaire-9
timeFrame: 1 month
Secondary outcomes:
measure: Montreal cognitive assessment scale (MoCA)
timeFrame: 1 month
measure: ocial support assessment scale (SSQ)
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ke Ma
state: Yangpu
Study officials:
affiliation: studay chair
name: ke na ma, phd
role: STUDY_CHAIR
References: