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

NCT03709238 | Completed

• 1 other identifier: UAarhus_Susan
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Pain; Alzheimers disease

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale (NRS)

  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 Outcomes (1)

• Pain Assessment in persons with Impaired Cognition (PAIC)

  Participants will be video recorded on each of the three test days during testing.

Study Arms (2)

Alzheimers diseased patients

Behavioral: Different thermal stimulation. Recording of facial expression during thermal stimulation.

Behavioral: Thermal stimulation

Healthy participants

Behavioral: Different thermal stimulation. Recording of facial expression during thermal stimulation.

Behavioral: Thermal stimulation

Interventions

Thermal stimulation BEHAVIORAL

Thermal stimulation

Alzheimers diseased patients; Healthy participants

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Patients with Alzheimers disease 2. Healthy participants

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Psychology and Behavioural Sciences

Aarhus, Central Jutland, 8000, Denmark

Location

Related Publications (1)

• Matthiesen ST, Sieg M, Andersen SS, Amanzio M, Finnerup NB, Jensen TS, Gottrup H, Vase L. Placebo analgesia and nocebo hyperalgesia in patients with Alzheimer disease and healthy participants. Pain. 2024 Feb 1;165(2):440-449. doi: 10.1097/j.pain.0000000000003035. Epub 2023 Sep 8.

  PMID: 37703397 DERIVED

MeSH Terms

Conditions

Pain; Alzheimer Disease

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2018
• First Posted: October 17, 2018
• Study Start: January 3, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: March 31, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)