A Multi-center Clinical Longitudinal Study of Neuropathic Pain by Collecting Data

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

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

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Jingting Chen, phd; Phone Number: 13122778387; Email: 806041409@qq.com
• Study Contact Backup: Name: ke ma, phd; Phone Number: 13361879260; Email: marke72@163.com

Study Locations

• China
  • Yangpu
    • Shanghai, Yangpu, China, 200092
      • Recruiting
      • Ke Ma
      • Contact: Ke NA Ma, PHD; Phone Number: 13361879260; Email: marke72@163.com

Participation Criteria

Eligibility Criteria

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

• 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;

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with neuropathic pain; With prospective and longitudinal research design, patients with neuropathic pain that meet the entry/displacement standards will be included in the group and receive the routine diagnosis and treatment of the pain department. At the same time, the patients admitted to the group will be clinical observation and studied. After the diagnosis and treatment, follow-up will be carried out until 3 months after joining the group.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale/Score（VAS）	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.	1 month
digital pain grading method (NRS)	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.	1 month
neuropathic pain assessment scale (DN4)	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.	1 month
sleep quality (Pittsburgh sleep quality index, Ascens insomnia scale)	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.	1 month
Barrett impulse scale (BIS)	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.	1 month
(Generalized Anxiety Disorder,GAD-7)	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	1 month
(Patient Health Questionnaire-9	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.	1 month
EEG	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。	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ocial support assessment scale (SSQ)	Each group of questions asked (A) how satisfied you are with the number of people who help or support you in your life, and (B) how satisfied you are with the way they / they help you.1= very dissatisfied, and 6= very satisfied.	1 month
Montreal cognitive assessment scale (MoCA)	The Montreal Cognitive Assessment (Montreal Cognitive Assessment, MoCA) is a rating tool for rapid screening of cognitive abnormalities. It includes eight cognitive domains, including visual structure skills, executive function, memory, language, attention and concentration, calculation, abstract thinking and directional force. The total score of 30 and 26 were normal, with high sensitivity, covering important cognitive fields, short test time and suitable for clinical use.	1 month

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Study Chair: Ke NA Ma, phd, studay chair

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Estimated): July 15, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: XH-23-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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