Emotion Processing Among Patients With ALS

Официальное название

Emotion and Interoception Processing in ALS

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• The perception of facial emotions measured using an Emotion Discrimination Task (EDT). [Срок оценки: 20 minutes]
• Metacognitive sensitivity measured using a retrospective confidence rating scale [Срок оценки: 20 minutes]

Вторичные конечные точки (2)

• Subjects' heart rate is monitored throughout the EDT [Срок оценки: 20 minutes]
• Subjects' respiration is monitored throughout the EDT [Срок оценки: 20 minutes]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Дания · 2 центра

• Aarhus University Hospital — Aarhus
• Aalborg University Hospital — Aalborg

Публикации

• Swinnen B, Robberecht W. The phenotypic variability of amyotrophic lateral sclerosis. Nat Rev Neurol. 2014 Nov;10(11):661-70. doi: 10.1038/nrneurol.2014.184. Epub 2014 Oct 14. PMID 25311585
• Sedda A. Disorders of emotional processing in amyotrophic lateral sclerosis. Curr Opin Neurol. 2014 Dec;27(6):659-65. doi: 10.1097/WCO.0000000000000147. PMID 25333604
• Strong MJ, Abrahams S, Goldstein LH, Woolley S, Mclaughlin P, Snowden J, Mioshi E, Roberts-South A, Benatar M, HortobaGyi T, Rosenfeld J, Silani V, Ince PG, Turner MR. Amyotrophic lateral sclerosis - frontotemporal spectrum disorder (ALS-FTSD): Revised diagnostic criteria. Amyotroph Lateral Scler Frontotemporal Degener. 2017 May;18(3-4):153-174. doi: 10.1080/21678421.2016.1267768. Epub 2017 Jan 5. PMID 28054827
• Strong MJ, Yang W. The frontotemporal syndromes of ALS. Clinicopathological correlates. J Mol Neurosci. 2011 Nov;45(3):648-55. doi: 10.1007/s12031-011-9609-0. Epub 2011 Aug 2. PMID 21809041
• Bora E. Meta-analysis of social cognition in amyotrophic lateral sclerosis. Cortex. 2017 Mar;88:1-7. doi: 10.1016/j.cortex.2016.11.012. Epub 2016 Dec 5. PMID 28002755
• Martins AP, Prado LGR, Lillo P, Mioshi E, Teixeira AL, de Souza LC. Deficits in Emotion Recognition as Markers of Frontal Behavioral Dysfunction in Amyotrophic Lateral Sclerosis. J Neuropsychiatry Clin Neurosci. 2019 Spring;31(2):165-169. doi: 10.1176/appi.neuropsych.18040086. Epub 2018 Dec 12. PMID 30537912
• Oh SI, Oh KW, Kim HJ, Park JS, Kim SH. Impaired Perception of Emotional Expression in Amyotrophic Lateral Sclerosis. J Clin Neurol. 2016 Jul;12(3):295-300. doi: 10.3988/jcn.2016.12.3.295. Epub 2016 Apr 19. PMID 27095526
• Zimmerman EK, Eslinger PJ, Simmons Z, Barrett AM. Emotional perception deficits in amyotrophic lateral sclerosis. Cogn Behav Neurol. 2007 Jun;20(2):79-82. doi: 10.1097/WNN.0b013e31804c700b. PMID 17558250

Идентификаторы

NCT: NCT06566651 · emotionperceptionALS11072308

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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