Recognizing Pain Intensity in Alzheimer's Disease

Not Applicable

Terminated

• Conditions: Autonomic Nervous System Disease; Alzheimer Disease; Pain
• Interventions: Diagnostic Test: cognitive assessment; Other: Cold Pressor Test; Other: digital sensor of Nociception Level Index

• Registration Number: NCT04614532
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

The most common form of dementia is Alzheimer's disease, with 900,000 people affected in France in 2015 and a forecast of 1.3 million in 2020. As a consequence of their advanced age, dementia patients often suffer from pain, mainly musculoskeletal or neuropathic pain. However, the exact prevalence of pain in dementia is underestimated. Indeed, several studies indicate that people suffering from dementia report less pain. This phenomenon is all the more true as the stage of dementia is advanced. In addition, people with dementia receive less pain medication than people without cognitive impairment in similarly painful conditions. Hetero-evaluation alone also seems insufficient, with the result that pain is under-treated compared to patients without cognitive impairment. Better pain screening is a major challenge and self-assessment tools should be favoured as a first line of treatment, even for patients with cognitive impairment. suffering from dementia.

The investigators propose in this work to evaluate the variation of vegetative parameters that accompany a painful stimulus. These variations can be recorded at the cardiac, vascular, pupillary or skin conductance level.

Detailed Description

It will therefore be a question of inducing experimental pain in patients with Alzheimer's disease, in the early stages of the disease and to check whether pain-related changes in the autonomic nervous system via the Nociception Level index (NoL® system) differ from a control group of subjects matched in age, gender and education level. To induce pain, the investigators will use the "cold pressor test" technique, which consists of leaving the arm immersed in ice water for as long as the pain is bearable. The investigators will also record before, during and after the immersion, the variations of several parameters derived from the autonomic nervous system during the painful stimulation via the NoL® system. During this experience, the participants will be filmed in their entirety to observe the facial emotions related to pain.

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-11-04
• Study Start: 2021-11-24
• Primary Completion: 2023-04-06
• Study Completion: 2023-04-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with alzheimer's disease	digital sensor of Nociception Level Index	-
patients with alzheimer's disease	cognitive assessment	-
control subject	cognitive assessment	Matching by age (± 5 years), gender, and grade level
control subject	digital sensor of Nociception Level Index	Matching by age (± 5 years), gender, and grade level
patients with alzheimer's disease	Cold Pressor Test	-
control subject	Cold Pressor Test	Matching by age (± 5 years), gender, and grade level

Primary Outcome Measures

Name	Time	Method
Nociception Level Index	30 minutes	measured for at least 5 minutes before immersion of the arm to have a control measurement. The measurement will continue throughout the time of immersion of the arm and until the arm is out of the water and returns to the control measurement value. This measurement will be taken via a sensor placed on a finger of the contro-lateral hand.; an index at 0 = absence of nociception, an index at 100 = maximum nociception

Secondary Outcome Measures

Name	Time	Method
facial recognition	30 minutes	The subjects will be fully filmed during the procedure. The video will be analyzed after experimentation, thanks to the Facereader® software. Facereader® is a fully automated system for the recognition of facial expressions, allowing an objective evaluation of the emotion of the topics. It uses the Viola-Jones algorithm allowing a 3D modeling of the face as well as the taking in account of the texture of the face. Then, each unit of action of the Facial Action Coding System (FACS) will be assigned to the face. of the patient. The five facial expressions of pain will be integrated into the software allowing them to be automatic recognition. The parameters used will be the intensity of the emotion expression (from 0 to 100).

Trial Locations

Locations (1)

CHU de Saint Etienne; 🇫🇷 Saint-Étienne, France