Clinical trial NCT06566651: Emotion Processing Among Patients With ALS
Official title: Emotion and Interoception Processing in ALS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis
Neuromuscular Diseases
ALS
Motor Neuron Disease
MND (Motor Neurone DIsease)
Keywords: Amyotrophic Lateral Sclerosis
Neuromuscular Diseases
Emotion Perception
Emotion Processing
Emotion Recognition
Autonomic Responses
Respiratory Responses
Heart rate
Emotion Discrimination Task
ALS
Motorneuron disease
MND
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Aalborg University Hospital
First posted: 2024-08-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Residents of Aarhus and Aalborg
* Patients at Aarhus University Hospital
* Patients at Aalborg University Hospital

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The perception of facial emotions measured using an Emotion Discrimination Task (EDT).
timeFrame: 20 minutes
measure: Metacognitive sensitivity measured using a retrospective confidence rating scale
timeFrame: 20 minutes
Secondary outcomes:
measure: Subjects' heart rate is monitored throughout the EDT
timeFrame: 20 minutes
measure: Subjects' respiration is monitored throughout the EDT
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Region Midtjylland
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Region Nordjulland
Study officials:
affiliation: Department of Neurology, Aarhus University Hospital
name: Mia B Heintzelmann, Cand.med
role: PRINCIPAL_INVESTIGATOR
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