Recognizing Pain Intensity in Alzheimer's Disease

NCT04614532 | Terminated

• 2 other identifiers: 20CH1582020-A02291-38
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Pain; Autonomic Nervous System Disease

Keywords

facial emotion

Outcome Measures

Primary Outcomes (1)

• Nociception Level Index

  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

  30 minutes

Secondary Outcomes (1)

• facial recognition

  30 minutes

Study Arms (2)

patients with alzheimer's disease

OTHER

Diagnostic Test: cognitive assessment; Other: Cold Pressor Test; Other: digital sensor of Nociception Level Index

control subject

OTHER

Matching by age (± 5 years), gender, and grade level

Diagnostic Test: cognitive assessment; Other: Cold Pressor Test; Other: digital sensor of Nociception Level Index

Interventions

cognitive assessment DIAGNOSTIC_TEST

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

control subject; patients with alzheimer's disease

Cold Pressor Test OTHER

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.

control subject; patients with alzheimer's disease

digital sensor of Nociception Level Index OTHER

placed on the contralateral index finger with the arm immersed in the tank to measure the variation of physiological parameters.

control subject; patients with alzheimer's disease

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of the disease by a hospital doctor after an etiological assessment including at least a cerebral MRI, a neuropsychological assessment and, if possible, dementia markers in the cerebrospinal fluid.
• Mini Mental State Score \> 23
• \- Matching by age (± 5 years), gender, and grade level

You may not qualify if:

• presence of pain,
• Presence of mood and/or psychiatric disorders (HAD A ou A scores \>7).
• Presence of cardiovascular risk factors and beta-blocker and/or calcium channel blocker therapy.
• Patients under guardianship or curatorship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Pain

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Céline BORG, MD

  CHU of Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: November 24, 2021
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)