Emotion Processing Among Patients With ALS

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Aarhus

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Emotion Discrimination Task (EDT)

    Other intervention

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

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Amyotrophic Lateral Sclerosis (ALS)1 intervention
Group B: Neuromuscular1 intervention
Group C: Control1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

Subjects' respiration is monitored throughout the EDT

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

Time frame
20 minutes

Other outcomes

Sponsors and contacts

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University of Aarhus

Lead sponsor

Aarhus University Hospital

Collaborator

Aalborg University Hospital

Collaborator