Emotion Processing Among Patients With ALS

Recruiting

• Conditions: ALS; Motor Neuron Disease; MND (Motor Neurone DIsease); Neuromuscular Diseases; Amyotrophic Lateral Sclerosis
• Interventions: Other: Emotion Discrimination Task (EDT)

• Registration Number: NCT06566651
• Lead Sponsor: University of Aarhus

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-11-28
• Study Start: 2023-12-15
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-20
• Last Update Submitted: 2024-08-20
• Study First Posted: 2024-08-22
• Last Update Posted: 2024-08-22
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Emotion Discrimination Task (EDT)	Healthy people
Amyotrophic Lateral Sclerosis (ALS)	Emotion Discrimination Task (EDT)	People diagnosed or suspected of having the neurodegenerative disease Amyotrophic Lateral Sclerosis (ALS)
Neuromuscular	Emotion Discrimination Task (EDT)	People diagnosed with a neuromuscular disease other than ALS

Primary Outcome Measures

Name	Time	Method
The perception of facial emotions measured using an Emotion Discrimination Task (EDT).	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.
Metacognitive sensitivity measured using a retrospective confidence rating scale	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 Outcome Measures

Name	Time	Method
Subjects' respiration is monitored throughout the EDT	20 minutes	Subjects' respiration is measured using a respiratory belt around the upper torso.
Subjects' heart rate is monitored throughout the EDT	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.

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus, Region Midtjylland, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Region Nordjulland, Denmark