Recognizing Pain Intensity in Alzheimer's Disease

NCT ID: NCT04614532

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-24
• Study Completion Date: 2023-04-06

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.

Conditions

Alzheimer Disease; Pain; Autonomic Nervous System Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

patients with alzheimer's disease

Group Type: OTHER

cognitive assessment

Intervention Type: 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

Cold Pressor Test

Intervention Type: 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.

digital sensor of Nociception Level Index

Intervention Type: OTHER

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

control subject

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

Group Type: OTHER

cognitive assessment

Intervention Type: 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

Cold Pressor Test

Intervention Type: 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.

digital sensor of Nociception Level Index

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Céline BORG, MD

Role: PRINCIPAL_INVESTIGATOR

CHU of Saint Etienne

Locations

CHU de Saint Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

2020-A02291-38

Identifier Type: OTHER

Identifier Source: secondary_id

20CH158

Identifier Type: -

Identifier Source: org_study_id