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NCT Number: NCT06290024

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

-

Treatment and study plan

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

Device

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.

Primary outcomes

  1. Visual Analogue Scale/Score(VAS)

    Time frame: 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.

  2. digital pain grading method (NRS)

    Time frame: 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.

  3. neuropathic pain assessment scale (DN4)

    Time frame: 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.

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

    Time frame: 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.

  5. EEG

    Time frame: 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。

  6. Barrett impulse scale (BIS)

    Time frame: 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.

  7. (Generalized Anxiety Disorder,GAD-7)

    Time frame: 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

  8. (Patient Health Questionnaire-9

    Time frame: 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.

Secondary outcomes

  1. Montreal cognitive assessment scale (MoCA)

    Time frame: 1 month

    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.

  2. ocial support assessment scale (SSQ)

    Time frame: 1 month

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

jingting chen, phd

CONTACT

[email protected]

13122778387

ke ma, phd

CONTACT

[email protected]

13361879260

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2024
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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