DNIC Using Deep Learning and Artificial Intelligence

Sponsor
Université de Sherbrooke (Other)
Overall Status
Recruiting
CT.gov ID
NCT04896827
Collaborator
Lucine (Industry), Centre for Research of CHUS (CRCHUS) (Other)
244
1
19.9
12.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Conditioned pain modulation test

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 Design

Study Type:
Observational
Anticipated Enrollment :
244 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Reference Values and Clinical Screening Test of Diffuse Noxious Inhibitory Controls (DNIC) Using Deep Learning and Artificial Intelligence
Actual Study Start Date :
Apr 5, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Conditioned pain modulation (CPM) profiles [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.

  2. Temporal summation profiles [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.

Secondary Outcome Measures

  1. Conditioned pain modulation (CPM) profiles of healthy volunteers [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.

  2. Temporal summation profiles of healthy volunteers [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.

  3. Conditioned pain modulation (CPM) profiles of volunteers with chronic pain [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.

  4. Temporal summation profiles of volunteers with chronic pain [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.

  5. Demographic factors [Once, at baseline, at recruitment]

    Association of demographic factors (age, gender) with different response profiles of CPM and temporal summation established by the algorithm.

  6. Psychologic factors [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.

  7. Physiologic factors [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.

  8. Facial expressions and postures [Once, at baseline, at recruitment]

    Association of facial expressions and postures with different response profiles of CPM and temporal summation established by the algorithm.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Université de Sherbrooke Sherbrooke Quebec Canada J1H 5N4

Sponsors and Collaborators

  • Université de Sherbrooke
  • Lucine
  • Centre for Research of CHUS (CRCHUS)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT04896827
Other Study ID Numbers:
  • 2021-4227
First Posted:
May 21, 2021
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Université de Sherbrooke
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022