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NCT Number: NCT06566651

Emotion Processing Among Patients With 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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis ALS Central Nervous System Diseases MND (Motor Neurone DIsease) Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital, Aarhus, Central Jutland, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Emotion Discrimination Task (EDT)

Other

It estimates the subjective bias and sensitivity in discriminating between happy and angry facial expressions of different intensities of emotional expression

Primary outcomes

  1. 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.

  2. 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".

Secondary outcomes

  1. 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.

  2. Subjects' respiration is monitored throughout the EDT

    Time frame: 20 minutes

    Subjects' respiration is measured using a respiratory belt around the upper torso.

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Hakala, Bach.psych

CONTACT

[email protected]

26332857

Mia B Heintzelmann, Cand.med

CONTACT

[email protected]

78454255

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University Hospital
  • Aarhus University Hospital

Registry information

Official study title

Emotion and Interoception Processing in ALS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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