DNIC Using Deep Learning and Artificial Intelligence

NCT04896827 | Suspended

• 1 other identifier: 2021-4227
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Conditioned pain modulation (CPM); Diffuse Noxious Inhibitory Controls (DNIC); Pressure pain threshold (PPT); Reference values; Clinical decision rule; Deep learning; Artificial intelligence

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (8)

• Conditioned pain modulation (CPM) profiles of healthy volunteers

  Once, at baseline, at recruitment (comparison between 1st and 2nd test, after the conditioning stimuli

• Temporal summation profiles of healthy volunteers

  Once, at baseline, at recruitment (during the first stimuli test)

• 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)

• Temporal summation profiles of volunteers with chronic pain

  Once, at baseline, at recruitment (during the first stimuli test)

• Demographic factors

  Once, at baseline, at recruitment

Study Arms (2)

Chronic pain

Patients with chronic pain (n=100)

Other: Conditioned pain modulation test

Healthy participants

Healthy participants (n=144)

Other: Conditioned pain modulation test

Interventions

Conditioned pain modulation test OTHER

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.

Chronic pain; Healthy participants

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male and female volunteers, with and without chronic pain.

You may qualify if:

• years old
• No chronic pain
• Able to provide consent

You may not qualify if:

• 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
• years old
• Chronic pain (chronic pain is defined by any regular pain for more than 6 months)
• Able to provide consent
• 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

Sponsors & Collaborators

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

Study Sites (1)

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillaume Léonard, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 21, 2021
• Study Start: April 5, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

CA (1)