Cognitive DeteriorationNCT06256666
Objective Measurement of Pain in Individuals With Cognitive Deterioration Utilizing Electroencephalography
An observational study of Cognitive Deterioration, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
Trial summary
This research addresses the challenge of pain assessment in individuals with cognitive deterioration (CD), a common aspect of aging and various neurological conditions. Due to difficulties in self-reporting, especially in severe cases, accurate pain diagnosis and management are hindered. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Cognitive Deterioration
- What is being tested?
- BIS Quantitative EEG
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 16 Sep 2024to 8 Jun 2025
- Phase
- Observational
- 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 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients admitted to general surgery and orthopedics, departments at Volterra Hospital with cognitive deterioration, undergoing major surgery.
Who may be able to join
- Subjects exhibiting at least moderate cognitive impairment as assessed by the Pfeiffer scale.
Who cannot join
- lack of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Objective Pain Assessment in Individuals With Cognitive Deterioration: Electroencephalographic Markers and Machine Learning Analysis
This research addresses the challenge of pain assessment in individuals with cognitive deterioration (CD), a common aspect of aging and various neurological conditions. Due to difficulties in self-reporting, especially in severe cases, accurate pain diagnosis and management are hindered. The study explores the use of electroencephalography (EEG) and machine learning techniques to objectively measure pain in CD patients. Utilizing a BIS device, the research aims to identify EEG markers associated with pain, comparing them with an objective PANAID scale. The study targets patients in surgical departments, providing valuable insights into enhancing pain assessment for those unable to express pain through traditional subjective scales.
Read the detailed description
Cognitive deterioration (CD) may develop during the aging process and is a characteristic feature of various neurological and neurodegenerative diseases. Individuals with CD often face significant, prolonged, and intricate healthcare needs, frequently involving pain. However, effectively communicating pain characteristics becomes a challenge for individuals with CD, presenting a substantial obstacle to the accurate diagnosis and treatment of pain. CD affects various patient groups, although current data predominantly focus on dementia patients, revealing pain prevalence ranging from 40% to over 80%, depending on the context .
Due to its subjective nature, pain assessment relies predominantly on self-reporting. Individuals with CD often encounter difficulties in verbally expressing their pain due to limited intellectual and communicative abilities. Even when verbal skills are present, they may not guarantee valid pain reports. Consequently, pain assessment poses challenges for individuals with CD, particularly those with severe CD, elevating the risk of delayed or inaccurate pain diagnoses. Self-assessments or patient-reported measures are considered the gold standard in clinical pain assessment.
For individuals with compromised cognitive or linguistic abilities, or when self-assessment is impractical or invalid, behavioral measures can be employed. These tools capture facial expressions, vocalizations, or body movements as indicators of pain from an external observer's perspective, such as nurses, physicians, or healthcare providers. However, these parameters rely entirely on others being attentive to non-verbal pain signals, presenting a challenge as trained observers must reliably distinguish pain from various other facial and bodily expressions.
Developing objective measures reflecting the presence of painful states appears crucial to improving pain management in various clinical situations. In this regard, electroencephalographic (EEG) activation has been described as a cortical correlate of pain processing. Encouraging results have led researchers to consider increased gamma band activity as a potential indicator of pain presence applicable in clinical conditions.
This study employs a commonly used BIS device in hospitals to objectively measure pain levels in subjects with cognitive deterioration. Quantitative electroencephalography (qEEG) data will be obtained, and machine learning techniques will be applied for data analysis. Thirty patients experiencing cognitive decline, admitted to the general surgery and orthopedics departments at Volterra Hospital for significant surgical interventions, will be enrolled in the study. Concurrently, pain will be assessed using an objective PANAID scale and, if applicable, the NRS. The study aims to identify electroencephalographic markers of pain through machine learning techniques and establish correlations with pain levels obtained from the use of both subjective and objective scales
- Conditions
- Cognitive Deterioration
- Being tested
- BIS Quantitative EEG
- Keywords
- Cognitive deterioration, Pain assessment, Quantitative electroencephalography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS Quantitative EEGDevice
Pain assessment will be conducted before and in the postoperative period using the objective PANAID scale and, when possible, the NRS. Simultaneously, EEG recordings using the BIS (Bispectral Index) will be performed. Cognitive status will be assessed before surgery using the Pfeiffer scale
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of the BIS device for the objective quantification of pain levels in patients with cognitive deterioration.
The outlined study aims to investigate and address the challenges associated with pain assessment in individuals with cognitive deterioration (CD), particularly focusing on hospidalized subjects admitted to general surgery, and orthopedics . The primary objective is to employ a commonly used BIS device in hospitals for the objective measurement of pain levels in these patients.
Measured: 20 minutes
Secondary outcomes (1)
Correlation between the identified electroencephalographic markers and a specific behavioral indicators of pain
The study may also investigate the correlation between the identified electroencephalographic markers and specific behavioral indicators of pain. By examining the concordance between EEG data and observable behaviors captured by external observers, such as nurses or physicians, the research could provide additional insights into the validity and comprehensiveness of EEG-based pain assessments.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start16 Sep 2024
- Primary completion1 May 2025
- Study completion8 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeteriorationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Nord Ovest
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto per la Ricerca e l'Innovazione Biomedica
- Responsible party
- Principal investigator, Alessandro Tani, Azienda USL Toscana Nord Ovest
- Investigators
- Alessandro Tani, MD, Principal investigator, Azienda USL Toscana Nord Ovest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256666
- Sponsor's protocol ID
- AUSLNordOvest 2024
- Status last verified
- Sep 2024
- First submitted
- 3 Feb 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kimura A, Mitsukura Y, Oya A, Matsumoto M, Nakamura M, Kanaji A, Miyamoto T. Objective characterization of hip pain levels during walking by combining quantitative electroencephalography with machine learning. Sci Rep. 2021 Feb 4;11(1):3192. doi: 10.1038/s41598-021-82696-1.
PubMed 33542388
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Objective Pain Assessment in Individuals With Cognitive Deterioration: Electroencephalographic Markers and Machine Learning Analysis
- ClinicalTrials.gov ID
- NCT06256666
- Acronym / sponsor ID
- AUSLNordOvest 2024
- Conditions
- Cognitive Deterioration
- Keywords
- Cognitive deterioration, Pain assessment, Quantitative electroencephalography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Azienda USL Toscana Nord OvestUniversity, hospital or other
- Collaborators
- Istituto per la Ricerca e l'Innovazione Biomedica
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 8 Jun 2025 (actual)
- First posted
- 13 Feb 2024 (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.
This research addresses the challenge of pain assessment in individuals with cognitive deterioration (CD), a common aspect of aging and various neurological conditions. Due to difficulties in self-reporting, especially in severe cases, accurate pain diagnosis and management are hindered. The study explores the use of electroencephalography (EEG) and machine learning techniques to objectively measure pain in CD patients. Utilizing a BIS device, the research aims to identify EEG markers associated with pain, comparing them with an objective PANAID scale. The study targets patients in surgical departments, providing valuable insights into enhancing pain assessment for those unable to express pain through traditional subjective scales.
Detailed description
Cognitive deterioration (CD) may develop during the aging process and is a characteristic feature of various neurological and neurodegenerative diseases. Individuals with CD often face significant, prolonged, and intricate healthcare needs, frequently involving pain. However, effectively communicating pain characteristics becomes a challenge for individuals with CD, presenting a substantial obstacle to the accurate diagnosis and treatment of pain. CD affects various patient groups, although current data predominantly focus on dementia patients, revealing pain prevalence ranging from 40% to over 80%, depending on the context .
Due to its subjective nature, pain assessment relies predominantly on self-reporting. Individuals with CD often encounter difficulties in verbally expressing their pain due to limited intellectual and communicative abilities. Even when verbal skills are present, they may not guarantee valid pain reports. Consequently, pain assessment poses challenges for individuals with CD, particularly those with severe CD, elevating the risk of delayed or inaccurate pain diagnoses. Self-assessments or patient-reported measures are considered the gold standard in clinical pain assessment.
For individuals with compromised cognitive or linguistic abilities, or when self-assessment is impractical or invalid, behavioral measures can be employed. These tools capture facial expressions, vocalizations, or body movements as indicators of pain from an external observer's perspective, such as nurses, physicians, or healthcare providers. However, these parameters rely entirely on others being attentive to non-verbal pain signals, presenting a challenge as trained observers must reliably distinguish pain from various other facial and bodily expressions.
Developing objective measures reflecting the presence of painful states appears crucial to improving pain management in various clinical situations. In this regard, electroencephalographic (EEG) activation has been described as a cortical correlate of pain processing. Encouraging results have led researchers to consider increased gamma band activity as a potential indicator of pain presence applicable in clinical conditions.
This study employs a commonly used BIS device in hospitals to objectively measure pain levels in subjects with cognitive deterioration. Quantitative electroencephalography (qEEG) data will be obtained, and machine learning techniques will be applied for data analysis. Thirty patients experiencing cognitive decline, admitted to the general surgery and orthopedics departments at Volterra Hospital for significant surgical interventions, will be enrolled in the study. Concurrently, pain will be assessed using an objective PANAID scale and, if applicable, the NRS. The study aims to identify electroencephalographic markers of pain through machine learning techniques and establish correlations with pain levels obtained from the use of both subjective and objective scales
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients admitted to general surgery and orthopedics, departments at Volterra Hospital with cognitive deterioration, undergoing major surgery.
Key inclusion criteria (1 listed)
- Subjects exhibiting at least moderate cognitive impairment as assessed by the Pfeiffer scale.
Key exclusion criteria (1 listed)
- lack of consent
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 |
|---|---|---|
| BIS Quantitative EEGPain assessment will be conducted before and in the postoperative period using the objective PANAID scale and, when possible, the NRS. Simultaneously, EEG recordings using the BIS (Bispectral Index) will be performed. Cognitive status will be assessed before surgery using the Pfeiffer scale | Device | – |
Primary outcome
Utilization of the BIS device for the objective quantification of pain levels in patients with cognitive deterioration.
Time frame: 20 minutes
The outlined study aims to investigate and address the challenges associated with pain assessment in individuals with cognitive deterioration (CD), particularly focusing on hospidalized subjects admitted to general surgery, and orthopedics . The primary objective is to employ a commonly used BIS device in hospitals for the objective measurement of pain levels in these patients.
1 secondary outcome
Correlation between the identified electroencephalographic markers and a specific behavioral indicators of pain
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Results publication: PubMed 33542388Kimura A, Mitsukura Y, Oya A, Matsumoto M, Nakamura M, Kanaji A, Miyamoto T. Objective characterization of hip pain levels during walking by combining quantitative electroencephalography with machine learning. Sci Rep. 2021 Feb 4;11(1):3192. doi: 10.1038/s41598-021-82696-1.
- 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.
Alessandro Tani, MD principal investigator
Azienda USL Toscana Nord Ovest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Deterioration, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Sep 2025. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Utilization of the BIS device for the objective quantification of pain levels in patients with cognitive deterioration. (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06256666, which also lists 1 linked publication.
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 30 Sep 2025.