NCT04614532

Recognizing Pain Intensity in Alzheimer's Disease

Recognizing Pain Intensity in Alzheimer's Disease: Autonomic Nervous System Variations and Facial Emotion

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alzheimer Disease
• Pain
• Autonomic Nervous System Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	cognitive assessment	global cognitive assessment : * Mini Mental State * Evaluation of manual laterality * Hospital Anxiety and Depression scale * 5 words of Dubois * Trail Making Test * short battery of the praxies * neuropathic pain scale (DN4 in french) * Analog Visual Scale for pain * Fast Front End Efficiency Battery
OTHER	Cold Pressor Test	consists of the complete immersion of the participant's arm in a basin of cold water maintained at a temperature. The test will be divided into two conditions (pain, no pain). In the first, the container will be filled with cold water. In the second, the water in the container will be at room temperature. The investigators will test each arm. During the immersion of the arm, participants will have to remain silent and remove their arm when the ordeal becomes too painful for the painful condition. For the non-painful condition, the immersion time will be determined according to the results of the pre test.
OTHER	digital sensor of Nociception Level Index	placed on the contralateral index finger with the arm immersed in the tank to measure the variation of physiological parameters.

Timeline

• Start date: 2021-11-24
• Primary completion: 2023-04-06
• Completion: 2023-04-06
• First posted: 2020-11-04
• Last updated: 2024-10-15

Locations

1 site across 1 country: France