Recognizing Pain Intensity in Alzheimer's Disease (DOMASNA)
Primary Purpose
Alzheimer Disease, Pain, Autonomic Nervous System Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cognitive assessment
Cold Pressor Test
digital sensor of Nociception Level Index
Sponsored by
About this trial
This is an interventional other trial for Alzheimer Disease focused on measuring facial emotion
Eligibility Criteria
Inclusion Criteria for patients with alzheimer's disease :
- 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
Inclusion Criteria for control subject :
- Matching by age (± 5 years), gender, and grade level
Exclusion Criteria for 2 groups :
- 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
Sites / Locations
- CHU de Saint EtienneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
patients with alzheimer's disease
control subject
Arm Description
Matching by age (± 5 years), gender, and grade level
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
facial recognition
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).
Full Information
NCT ID
NCT04614532
First Posted
October 29, 2020
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT04614532
Brief Title
Recognizing Pain Intensity in Alzheimer's Disease
Acronym
DOMASNA
Official Title
Recognizing Pain Intensity in Alzheimer's Disease: Autonomic Nervous System Variations and Facial Emotion
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Pain, Autonomic Nervous System Disease
Keywords
facial emotion
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with alzheimer's disease
Arm Type
Other
Arm Title
control subject
Arm Type
Other
Arm Description
Matching by age (± 5 years), gender, and grade level
Intervention Type
Diagnostic Test
Intervention Name(s)
cognitive assessment
Intervention Description
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
Other
Intervention Name(s)
Cold Pressor Test
Intervention Description
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
Intervention Name(s)
digital sensor of Nociception Level Index
Intervention Description
placed on the contralateral index finger with the arm immersed in the tank to measure the variation of physiological parameters.
Primary Outcome Measure Information:
Title
Nociception Level Index
Description
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
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
facial recognition
Description
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).
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for patients with alzheimer's disease :
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
Inclusion Criteria for control subject :
- Matching by age (± 5 years), gender, and grade level
Exclusion Criteria for 2 groups :
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Céline BORG, MD
Phone
04 77 82 88 82
Ext
+33
Email
celine.borg@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Hélène RAINGARD, CRA
Phone
(0)4.77.82.97.03
Ext
+33
Email
helene.raingard@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline BORG, MD
Organizational Affiliation
CHU of Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline BORG
Phone
04 77 82 88 82
Email
celine.borg@chu-st-etienne.fr
First Name & Middle Initial & Last Name & Degree
Jean Claude GETENET, MD
First Name & Middle Initial & Last Name & Degree
Bernard LAURENT, MD
First Name & Middle Initial & Last Name & Degree
David CHARIER, MD
First Name & Middle Initial & Last Name & Degree
Julien LABOURE, MD
First Name & Middle Initial & Last Name & Degree
Isabelle ROUCH, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Recognizing Pain Intensity in Alzheimer's Disease
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