DNIC Using Deep Learning and Artificial Intelligence

Chronic Pain Clinical Trial

Official title:

Reference Values and Clinical Screening Test of Diffuse Noxious Inhibitory Controls (DNIC) Using Deep Learning and Artificial Intelligence

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04896827
• Other study ID #: 2021-4227
• Status: Suspended
• Start date: April 5, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic pain (CP) is disabling for people triggering important costs for society. A deficit of diffuse noxious inhibitory controls (DNIC) is one of the CP mechanisms. DNICs are evaluated in research setting using a CPM protocol (conditioned pain modulation). There is a lack of reference values on the effectiveness of DNICs. Wider research on DNIC will help to understand CP and to develop a clinical screening test evaluating DNICs. This study aims more specifically to determine whether it is possible to develop a facial recognition system to automate pain measurement and the effectiveness of pain control mechanisms.

Description:

This study aims:

1. To develop and validate a predictive tool (using deep learning and artificial intelligence) to estimate the efficacy of pain control mechanisms.

2. To estimate references values for facial expressions of pain control mechanisms in healthy and in chronic pain participants.

The target population will be healthy volunteers and volunteers with chronic pain, male and female, stratified by age.

The reference values (healthy volunteers) will be established via a non-parametric method for a standard conditioned pain modulation (CPM) protocol in which two "stimuli tests" of the same intensity and nature (heat) will be applied before and after the application of another "conditioning stimulus" (cold water bath). The perceived pain difference between the 1st and 2nd stimuli tests will reflect the intensity of the DNICs. Participants' facial expressions will be captured simultaneously by three cameras during the CPM testing.

These results will be compared to those from volunteers suffering with chronic pain. The clinical decision rule will result from clinical and paraclinical elements correlating with the amplitude of the efficacy of CPM (serum noradrenaline, intensity of pain, heart rate and blood pressure measurements, psychometric questionnaires assessing anxiety, depressive feelings and pain catastrophizing). Logistic regression analysis will determine the best predictors of a CPM deficit.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 244
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Healthy participants

Inclusion Criteria:

• 18-79 years old

• No chronic pain

• Able to provide consent

Exclusion Criteria:

• Cardiovascular disease (arrhythmia, cerebrovascular accident, infarction...)

• Raynaud syndrome

• Severe psychiatric disease (dementia, schizophrenia, psychosis, major depression)

• Injuries or loss sensitivity to their forearms or hands

• Pregnant women or in post-partum period (<1 year)

Participants with chronic pain

Inclusion Criteria:

• 18-79 years old

• Chronic pain (chronic pain is defined by any regular pain for more than 6 months)

• Able to provide consent

Exclusion Criteria:

• Cardiovascular disease (arrhythmia, cerebrovascular accident, infarction...)

• Raynaud syndrome

• Severe psychiatric disease (dementia, schizophrenia, psychosis, major depression)

• Injuries or loss sensitivity to their forearms or hands

• Pregnant women or in post-partum period (<1 year)

• Chronic pain caused by cancer or migraine

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• Conditioned pain modulation test
Conditioned pain modulation (CPM) protocol consist of evaluating pain during a heat test, before and after one conditioning stimulus (cold water bath); 3 cameras will be capturing participants' facial expressions during the tests.

Locations

Country	Name	City	State
Canada	Université de Sherbrooke	Sherbrooke	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université de Sherbrooke	Centre for Research of CHUS (CRCHUS), Lucine

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conditioned pain modulation (CPM) profiles	Sensitivity and specificity of the classification algorithm according to different profiles (normal vs altered) of conditioned pain modulation, as defined by the change of pain perception before and after the cold water bath measured by computerized visual analog scale (CoVAS) ranging from 0 [no pain] to 100 [most intense pain that could be tolerated] in healthy and in chronic pain volunteers together.	Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)
Primary	Temporal summation profiles	Sensitivity and specificity of the classification algorithm according to different profiles (normal vs altered) of temporal summation, as defined by the change of pain perception during the first stimuli test measured by computerized visual analog scale (CoVAS) ranging from 0 [no pain] to 100 [most intense pain that could be tolerated] in healthy and in chronic pain volunteers together.	Once, at baseline, at recruitment (during the first stimuli test)
Secondary	Conditioned pain modulation (CPM) profiles of healthy volunteers	Conditioned pain modulation, as defined by the change of pain perception before and after the cold water bath measured by computerized visual analog scale (CoVAS) ranging from 0 [no pain] to 100 [most intense pain that could be tolerated] only in healthy volunteers.	Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli
Secondary	Temporal summation profiles of healthy volunteers	Temporal summation, as defined by the change of pain perception during the first stimuli test measured by computerized visual analog scale (CoVAS) ranging from 0 [no pain] to 100 [most intense pain that could be tolerated] only in healthy volunteers.	Once, at baseline, at recruitment (during the first stimuli test)
Secondary	Conditioned pain modulation (CPM) profiles of volunteers with chronic pain	Conditioned pain modulation, as defined by the change of pain perception before and after the cold water bath measured by computerized visual analog scale (CoVAS) ranging from 0 [no pain] to 100 [most intense pain that could be tolerated] only in volunteers with chronic pain.	Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)
Secondary	Temporal summation profiles of volunteers with chronic pain	Temporal summation, as defined by the change of pain perception during the first stimuli test measured by computerized visual analog scale (CoVAS) ranging from 0 [no pain] to 100 [most intense pain that could be tolerated] only in volunteers with chronic pain.	Once, at baseline, at recruitment (during the first stimuli test)
Secondary	Demographic factors	Association of demographic factors (age, gender) with different response profiles of CPM and temporal summation established by the algorithm.	Once, at baseline, at recruitment
Secondary	Psychologic factors	Association of psychologic factors (anxiety measured with HADS questionnaire) with different response profiles of CPM and temporal summation established by the algorithm.	Once, at baseline, at recruitment
Secondary	Physiologic factors	Association of physiologic factors (continuous blood pressure, heart rate, electrodermal activity) with different response profiles of CPM and temporal summation established by the algorithm.	Once, at baseline, at recruitment
Secondary	Facial expressions and postures	Association of facial expressions and postures with different response profiles of CPM and temporal summation established by the algorithm.	Once, at baseline, at recruitment