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

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ClinicalTrials.gov Identifier: NCT03709238
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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.


Condition or disease Intervention/treatment
Pain Behavioral: Thermal stimulation

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain Processing and Pain Reporting in Patients With Alzheimer's Disease
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. Patients with Alzheimers disease
  2. Healthy participants
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709238


Contacts
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Contact: Susan T Matthiesen, Msc +4550941789 stm@psy.au.dk

Locations
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Denmark
Department of Psychology and Behavioural Sciences Recruiting
Aarhus, Midtjylland, Denmark, 8000
Contact: Susan T Matthiesen, Msc    +4550941789    stm@psy.au.dk   
Sponsors and Collaborators
University of Aarhus
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03709238    
Other Study ID Numbers: UAarhus_Susan
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
Pain
Alzheimers disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders