Pain Processing and Pain Reporting in Patients With Alzheimer's Disease

March 30, 2022 updated by: University of Aarhus

The study investigates pain processing and pain reporting in patients with Alzheimers disease compared to healthy participants.

Employing a within-subject design, the study includes patients with Alzheimers disease and healthy participants that are exposed to thermal stimuli. During the test session the facial expressions of the participant are video recorded.

By repeating this on separate test days, the involvement of pain relief and pain increase is investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Midtjylland
      • Aarhus, Midtjylland, Denmark, 8000
        • Department of Psychology and Behavioural Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  1. Patients with Alzheimers disease
  2. Healthy participants

Description

Inclusion Criteria:

  • Mild to moderate patients with Alzheimers disease (group 1)
  • Healthy participants ( group 2)

Exclusion Criteria:

  • Chronic pain conditions
  • Other medical, psychiatric or neurological disorders
  • Use of pain-reliving medication 24 hours prior to testing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Alzheimers diseased patients
Behavioral: Different thermal stimulation. Recording of facial expression during thermal stimulation.
Behavioral: Thermal stimulation
Thermal stimulation
Healthy participants
Behavioral: Different thermal stimulation. Recording of facial expression during thermal stimulation.
Behavioral: Thermal stimulation
Thermal stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical rating scale (NRS)
Time Frame: Participants will be tested on three different days. The numerical rating scale will be applied after each thermal stimulus for each test session.
Acute pain assessed on numerical rating scale from 0 (no pain experience) to 10 (worst pain), examining pain intensity. The participant will provide a number on the scale which reflects their pain intensity.
Participants will be tested on three different days. The numerical rating scale will be applied after each thermal stimulus for each test session.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Assessment in persons with Impaired Cognition (PAIC)
Time Frame: Participants will be video recorded on each of the three test days during testing.
Video recordings will be analyzed with the PAIC scale from 0 (not at all) to 3 (great degree).
Participants will be video recorded on each of the three test days during testing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 3, 2019

Primary Completion (ACTUAL)

August 31, 2021

Study Completion (ACTUAL)

August 31, 2021

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (ACTUAL)

October 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAarhus_Susan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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