An observational study in Amyotrophic Lateral Sclerosis, Neuromuscular Diseases and ALS, sponsored by University of Aarhus. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by University of Aarhus · Observational
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:
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.
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.
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's planned enrollment of 180 is above the median of 109 across 217 observational studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ALS patients, ambulant and hospitalized
Patients with a peripheral neuromuscular disease, ambulant and hospitalized
Healthy controls
Exclusion Criteria:
All Participants
Patients with a peripheral neuromuscular disease
● Familial predisposition to ALS
Healthy controls
People diagnosed or suspected of having the neurodegenerative disease Amyotrophic Lateral Sclerosis (ALS)
Other: Emotion Discrimination Task (EDT)
People diagnosed with a neuromuscular disease other than ALS
Other: Emotion Discrimination Task (EDT)
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
The perception of facial emotions measured using an Emotion Discrimination Task (EDT).
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.
Time frame: 20 minutes
Metacognitive sensitivity measured using a retrospective confidence rating scale
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".
Time frame: 20 minutes
Subjects' heart rate is monitored throughout the EDT
Subjects heart rate is measured through a standard 3-lead electrocardiogram montage. Electrodes were place on both collarbones and on the left lower rib.
Time frame: 20 minutes
Subjects' respiration is monitored throughout the EDT
Subjects' respiration is measured using a respiratory belt around the upper torso.
Time frame: 20 minutes
Plan to share: Yes — All collected IPD. Once the data is fully anonymized, they may be released on public scientific repositories such as Github or Figshare.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Aarhus