Alzheimer DiseaseDOMASNANCT04614532
Recognizing Pain Intensity in Alzheimer's Disease
A study testing cognitive assessment, Cold Pressor Test and digital sensor of Nociception Level Index in people with Alzheimer Disease and Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Pain, Autonomic Nervous System Disease
- What is being tested?
- cognitive assessment, Cold Pressor Test and digital sensor of Nociception Level Index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2021to 6 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recognizing Pain Intensity in Alzheimer's Disease: Autonomic Nervous System Variations and Facial Emotion
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.
Read the 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
- Being tested
- cognitive assessment, Cold Pressor Test, digital sensor of Nociception Level Index
- Keywords
- facial emotion
- Medical subject headings
- Alzheimer Disease, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive assessmentDiagnostic 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 TestOther
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 IndexOther
placed on the contralateral index finger with the arm immersed in the tank to measure the variation of physiological parameters.
| Study group | Role | What they receive |
|---|---|---|
| patients with alzheimer's disease | Other | Not described Receives: 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 Receives: Diagnostic Test: cognitive assessment; Other: Cold Pressor Test; Other: digital sensor of Nociception Level Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 minutes
Secondary outcomes (1)
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).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start24 Nov 2021
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Why it stopped: Reduced recruitment potential for study participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline BORG, MD, Principal investigator, CHU of Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614532
- Sponsor's protocol ID
- 20CH158
- Other IDs
- 2020-A02291-38
- Acronym
- DOMASNA
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recognizing Pain Intensity in Alzheimer's Disease: Autonomic Nervous System Variations and Facial Emotion
- ClinicalTrials.gov ID
- NCT04614532
- Acronym / sponsor ID
- DOMASNA / 20CH158
- Conditions
- Alzheimer Disease, Pain, Autonomic Nervous System Disease
- Keywords
- facial emotion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Reduced recruitment potential for study participants.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with alzheimer's disease | Other | Diagnostic Test: cognitive assessment, Other: Cold Pressor Test, Other: digital sensor of Nociception Level Index |
| control subject | Other | Diagnostic Test: cognitive assessment, Other: Cold Pressor Test, Other: digital sensor of Nociception Level IndexMatching by age (± 5 years), gender, and grade level |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive assessmentglobal 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 | Diagnostic test | control subject, patients with alzheimer's disease |
| Cold Pressor Testconsists 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 | control subject, patients with alzheimer's disease |
| digital sensor of Nociception Level Indexplaced on the contralateral index finger with the arm immersed in the tank to measure the variation of physiological parameters. | Other | control subject, patients with alzheimer's disease |
Primary outcome
Nociception Level Index
Time frame: 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
1 secondary outcome
facial recognition
Time frame: 30 minutes
Results and safety
The study was stopped early (reason given: Reduced recruitment potential for study participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Céline BORG, MD principal investigator
CHU of Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive assessment, Cold Pressor Test and digital sensor of Nociception Level Index in people with Alzheimer Disease and Pain, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Reduced recruitment potential for study participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nociception Level Index (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.