Emotion Processing Among Patients With ALS

August 20, 2024 updated by: Mia Heintzelmann, University of Aarhus

Emotion and Interoception Processing in ALS

The goal of this observational study is to learn about the emotional perception in people with ALS disease compared to people with other neuromuscular disease and healthy controls. The main questions it aims to answer are:

  • How people with ALS judge happy and angry faces and what their "insight" into these judgements are like
  • How their autonomic responses differ from the other two test group Participants will asked to judge if a face presents a happy emotion or angry emotion.

Researchers will compare the ALS group responses with neuromuscular diseases group and healthy control group responses to see if the ALS group judge more happy faces than angry.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Mild cognitive and behavioral changes occur in 35% of ALS patients and 10-15% of patients meet the criteria for FTD1-4. Recent research suggests changes in emotional perception and social cognition are a part of the neuropsychological changes in ALS, possibly associated with cognitive and behavioral symptoms seen in ALS-FTD5-9.

The aim of this project is to investigate emotional perception in ALS patients compared to healthy controls and patients with other neuromuscular diseases that do not affect the central nervous system. We use a simple emotion discrimination task to evaluate emotional bias and metacognition of emotion discrimination. Moreover, this project aims to explore the correlation between emotion perception and autonomic reactivity in ALS patients by recording heart rate frequency and respiration frequency during the EDT.

The project will contribute with deeper insights to the neuropsychological changes in ALS patients and the opportunity to quantify these changes. Thereby, the project will add new perspectives to the discussion of how we evaluate socio-emotional aspects of ALS in both clinical decision-making, guidance of relatives and future research.

Study Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

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

Study Contact

  • Name: Mia B Heintzelmann, Cand.med
  • Phone Number: 78454255
  • Email: minielse@rm.dk

Study Contact Backup

  • Name: Camilla Hakala, Bach.psych
  • Phone Number: 26332857
  • Email: caha@cfin.au.dk

Study Locations

  • Denmark
    • Region Midtjylland
      • Aarhus, Region Midtjylland, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
        • Contact:
          • Mia B Heintzelmann, Cand.med
          • Phone Number: 78454255
          • Email: minielse@rm.dk
    • Region Nordjulland
      • Aalborg, Region Nordjulland, Denmark, 9000
        • Not yet recruiting
        • Aalborg University Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

  • Residents of Aarhus and Aalborg
  • Patients at Aarhus University Hospital
  • Patients at Aalborg University Hospital

Description

Inclusion Criteria:

  • ALS patients, ambulant and hospitalized

    • Able to give informed consent
    • Diagnosed with ALS or probable ALS according to the existing revision of the El Escorial Criteria 21,22.

  • Patients with a peripheral neuromuscular disease, ambulant and hospitalized

    • Able to give informed consent
    • Diagnosed with a peripheral neuromuscular disease, that does not affect CNS, including but not limited to Myasthenia Gravis and polyneuropathy

  • Healthy controls

    • Able to give informed consent
    • Age and gender matched to ALS patients

Exclusion Criteria:

  • All Participants

    • Other severe medical, neurological, or psychiatric disorders
    • Visual impairment to an extent that interferes with the ability to perform of the test
    • Severe motor or cognitive deficits, to the extent that the test-task cannot be performed
    • Alcohol or drug abuse to an extent the interferes with task performance

  • Patients with a peripheral neuromuscular disease

    ● Familial predisposition to ALS

  • Healthy controls

    • Familial predisposition to ALS (first degree relatives)
    • Medical treatment that affects the central nervous system (e.g., antidepressants)

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
Control
Healthy people
Other: Emotion Discrimination Task (EDT)
It estimates the subjective bias and sensitivity in discriminating between happy and angry facial expressions of different intensities of emotional expression
Amyotrophic Lateral Sclerosis (ALS)
People diagnosed or suspected of having the neurodegenerative disease Amyotrophic Lateral Sclerosis (ALS)
Other: Emotion Discrimination Task (EDT)
It estimates the subjective bias and sensitivity in discriminating between happy and angry facial expressions of different intensities of emotional expression
Neuromuscular
People diagnosed with a neuromuscular disease other than ALS
Other: Emotion Discrimination Task (EDT)
It estimates the subjective bias and sensitivity in discriminating between happy and angry facial expressions of different intensities of emotional expression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The perception of facial emotions measured using an Emotion Discrimination Task (EDT).
Time Frame: 20 minutes
The EDT requires subjects to assess the facial emotion of a face stimulus and report whether the facial emotion was angry or happy. This will be the operationalisation of subjects' emotion perception, which we anticipate will reveal a bias towards positive perceptions. There is thus two scores on this scale: "Angry" and "Happy". There is no one of these scores that is "better" than the other. It is an nominal categorical scare.
20 minutes
Metacognitive sensitivity measured using a retrospective confidence rating scale
Time Frame: 20 minutes
Metacognitive insight will be operationalized through a metacognitive sensitivity measure. The method employed for this is a confidence rating measure, where subjects assess their own performance on the EDT. Subjects will indicate on a sliding scale, ranging from "very confident" (maximum score) to a "pure guess" (minimum score), how confident they are that their previous answer was correct. Generally higher scores on this scale is considered better. This scales title is: " Confidence Rating Scale".
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects' heart rate is monitored throughout the EDT
Time Frame: 20 minutes
Subjects heart rate is measured through a standard 3-lead electrocardiogram montage. Electrodes were place on both collarbones and on the left lower rib.
20 minutes
Subjects' respiration is monitored throughout the EDT
Time Frame: 20 minutes
Subjects' respiration is measured using a respiratory belt around the upper torso.
20 minutes

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
Aalborg University Hospital

Investigators

  • Principal Investigator: Mia B Heintzelmann, Cand.med, Department of Neurology, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 15, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • emotionperceptionALS11072308

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD. Once the data is fully anonymized, they may be released on public scientific repositories such as Github or Figshare.

IPD Sharing Time Frame

After the anonymizing the data, which is set to happen after collecting the data from the last participant being tested, the data will become available. The data will be available for minimum of 3 years.

IPD Sharing Access Criteria

Through approval by Aarhus University Hospital or Region Midtjylland can individuals receive the collected data. The data can potentially be used as part of a masters thesis.

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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