DNIC Using Deep Learning and Artificial Intelligence

November 28, 2023 updated by: Université de Sherbrooke

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

244

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Université de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Male and female volunteers, with and without chronic pain.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Chronic pain
Patients with chronic pain (n=100)
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.
Healthy participants
Healthy participants (n=144)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conditioned pain modulation (CPM) profiles
Time Frame: Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)
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)
Temporal summation profiles
Time Frame: Once, at baseline, at recruitment (during the first stimuli test)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conditioned pain modulation (CPM) profiles of healthy volunteers
Time Frame: Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli
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
Temporal summation profiles of healthy volunteers
Time Frame: Once, at baseline, at recruitment (during the first stimuli test)
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)
Conditioned pain modulation (CPM) profiles of volunteers with chronic pain
Time Frame: Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli)
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)
Temporal summation profiles of volunteers with chronic pain
Time Frame: Once, at baseline, at recruitment (during the first stimuli test)
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)
Demographic factors
Time Frame: Once, at baseline, at recruitment
Association of demographic factors (age, gender) with different response profiles of CPM and temporal summation established by the algorithm.
Once, at baseline, at recruitment
Psychologic factors
Time Frame: Once, at baseline, at recruitment
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
Physiologic factors
Time Frame: Once, at baseline, at recruitment
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
Facial expressions and postures
Time Frame: Once, at baseline, at recruitment
Association of facial expressions and postures with different response profiles of CPM and temporal summation established by the algorithm.
Once, at baseline, at recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Lucine
Centre for Research of CHUS (CRCHUS)

Investigators

  • Principal Investigator: Guillaume Léonard, PhD, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 17, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-4227

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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