- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06256666
Objective Measurement of Pain in Individuals With Cognitive Deterioration Utilizing Electroencephalography
Exploring Objective Pain Assessment in Individuals With Cognitive Deterioration: Electroencephalographic Markers and Machine Learning Analysis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alessandro Tani, MD
- Phone Number: 039 058891706
- Email: alessandro.tani113@gmail.com
Study Locations
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Pisa
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Volterra, Pisa, Italy, 56048
- Santa Maria Maddalena Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects exhibiting at least moderate cognitive impairment as assessed by the Pfeiffer scale.
Exclusion Criteria:
- lack of consent
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between the identified electroencephalographic markers and a specific behavioral indicators of pain
Time Frame: 20 minutes
|
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.
|
20 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alessandro Tani, MD, Azienda Usl Toscana Nord Ovest
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUSLNordOvest 2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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