Objective Measurement of Pain in Individuals With Cognitive Deterioration Utilizing Electroencephalography

NCT06256666 | Completed DMC

• 1 other identifier: AUSLNordOvest 2024
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Deterioration

Keywords

Cognitive deterioration; Pain assessment; Quantitative electroencephalography

Outcome Measures

Primary Outcomes (1)

• 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.

  20 minutes

Secondary Outcomes (1)

• Correlation between the identified electroencephalographic markers and a specific behavioral indicators of pain

  20 minutes

Interventions

BIS Quantitative EEG DEVICE

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

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to general surgery and orthopedics, departments at Volterra Hospital with cognitive deterioration, undergoing major surgery.

You may qualify if:

• Subjects exhibiting at least moderate cognitive impairment as assessed by the Pfeiffer scale.

You may not qualify if:

• lack of consent

Sponsors & Collaborators

• Azienda USL Toscana Nord Ovest: lead
• Istituto per la Ricerca e l'Innovazione Biomedica: collaborator

Study Sites (1)

Santa maria maddalena Hospital

Volterra, Pisa, 56048, Italy

Location

Related Publications (1)

• 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.

  PMID: 33542388 BACKGROUND

Study Officials

• Alessandro Tani, MD

  Azienda USL Toscana Nord Ovest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 13, 2024
• Study Start: September 16, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 8, 2025
• Last Updated: September 30, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)