跳至主要内容
临床试验/NCT06290024
NCT06290024招募中不适用

A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data on Patients' Brain Physiology and Cognitive Function

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2023年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
1
主要终点
EEG

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

EEG

时间窗: 1 month

To study the dynamic change of EEG wavelength during the progression from acute pain to chronic pain,four basic waveforms, α, β, θ, δ wave, were collected。

Visual Analogue Scale/Score(VAS)

时间窗: 1 month

VAS pain score criteria ((0-10 points) 0 Points: painless; 3 points below: have a slight pain, can tolerate; 4 points- -6 points: patients with pain and affect sleep, and can still tolerate; 7 points-10 points: the patient has gradually intense pain, the pain is unbearable, affect appetite, affect sleep.

Barrett impulse scale (BIS)

时间窗: 1 month

The subject's feeling, reaction and degree of recognition are regarded as evaluation indicators, and the five-point scale classification method is adopted. Action impulse is scored positively, and unplanned impulse and cognitive impulse are scored in reverse. The standard is: "1" means never or almost never; "2" means occasional; "3" means often; "4" means always or almost always.

digital pain grading method (NRS)

时间窗: 1 month

Score ranged from 1 to 5, and the higher the score, the more it suggested the possibility of neuropathic pain. Clinically, when patients score ID Pain 3, neuropathic pain-related treatment options will be considered.

neuropathic pain assessment scale (DN4)

时间窗: 1 month

Each assessment item was assigned 1 point for "yes" and 0 point for "no". The total score of DN4 is 0 to 10, and neuropathic pain when the total score is greater than or equal to 4.

sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale)

时间窗: 1 month

The PSQI was used to assess the sleep quality of the participants in the last 1 month. It consists of 19 self-assessment entries and 5 items, among which the 19th self-assessment entry and 5 items do not participate in the scoring. Only the 18 self-assessment entries participating in the scoring are introduced here (see the attached questionnaire for details). The 18 items formed 7 components, and each component was scored according to 0-3 levels. The cumulative score of PSQI total score ranged from 0 to 2 l. The higher the score, the worse the sleep quality.

(Generalized Anxiety Disorder,GAD-7)

时间窗: 1 month

Each entry is 0 to 3 points, the total score is the score of the 7 items, the total score ranges from 0 to 21 points A 0-4 score is found without a GAD And 5-9 points for mild GAD And 10 - 14 points for moderate GAD 15 - 21 for severe GAD

(Patient Health Questionnaire-9

时间窗: 1 month

Calculate the total score 0-4 points: no depression (take care of yourself) 5-9: possible mild depression (consult a psychologist or medical worker recommended) 10-14 points: There may be moderate depression (preferably consult a psychologist or psychological medicine worker) 15-19: possible moderate to severe depression (consult a psychiatrist or psychiatrist) 20-27: possible severe depression (be sure to see a psychologist or psychiatrist) Core project points Item 1, item 4, item 9, any question score\> 1 (select 2,3), need attention; item 1, item 4, representing the core symptoms of depression; Item 9 represents a self-injury mind.

次要结局

  • Montreal cognitive assessment scale (MoCA)(1 month)
  • ocial support assessment scale (SSQ)(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

A Multi-center Clinical Longitudinal Study of... | 临床试验