Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT06566651
Status:
RECRUITING
Last Update Posted:
2024-08-22
First Post:
2023-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emotion Processing Among Patients With ALS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The perception of facial emotions measured using an Emotion Discrimination Task (EDT).', 'timeFrame': '20 minutes', 'description': '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.'}, {'measure': 'Metacognitive sensitivity measured using a retrospective confidence rating scale', 'timeFrame': '20 minutes', 'description': '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".'}], 'secondaryOutcomes': [{'measure': "Subjects' heart rate is monitored throughout the EDT", 'timeFrame': '20 minutes', 'description': 'Subjects heart rate is measured through a standard 3-lead electrocardiogram montage. Electrodes were place on both collarbones and on the left lower rib.'}, {'measure': "Subjects' respiration is monitored throughout the EDT", 'timeFrame': '20 minutes', 'description': "Subjects' respiration is measured using a respiratory belt around the upper torso."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Amyotrophic Lateral Sclerosis', 'Neuromuscular Diseases', 'ALS', 'Motor Neuron Disease', 'MND (Motor Neurone DIsease)']}, 'referencesModule': {'references': [{'pmid': '25311585', 'type': 'BACKGROUND', 'citation': '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': '25333604', 'type': 'BACKGROUND', 'citation': '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': '28054827', 'type': 'BACKGROUND', 'citation': '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': '21809041', 'type': 'BACKGROUND', 'citation': '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': '28002755', 'type': 'BACKGROUND', 'citation': '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': '30537912', 'type': 'BACKGROUND', 'citation': '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': '27095526', 'type': 'BACKGROUND', 'citation': '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': '17558250', 'type': 'BACKGROUND', 'citation': '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': '15977000', 'type': 'BACKGROUND', 'citation': 'Lule D, Kurt A, Jurgens R, Kassubek J, Diekmann V, Kraft E, Neumann N, Ludolph AC, Birbaumer N, Anders S. Emotional responding in amyotrophic lateral sclerosis. J Neurol. 2005 Dec;252(12):1517-24. doi: 10.1007/s00415-005-0907-8. Epub 2005 Jun 24.'}, {'pmid': '24534360', 'type': 'BACKGROUND', 'citation': 'Crespi C, Cerami C, Dodich A, Canessa N, Arpone M, Iannaccone S, Corbo M, Lunetta C, Scola E, Falini A, Cappa SF. Microstructural white matter correlates of emotion recognition impairment in Amyotrophic Lateral Sclerosis. Cortex. 2014 Apr;53:1-8. doi: 10.1016/j.cortex.2014.01.002. Epub 2014 Jan 18.'}, {'pmid': '17401515', 'type': 'BACKGROUND', 'citation': 'Lule D, Diekmann V, Anders S, Kassubek J, Kubler A, Ludolph AC, Birbaumer N. Brain responses to emotional stimuli in patients with amyotrophic lateral sclerosis (ALS). J Neurol. 2007 Apr;254(4):519-27. doi: 10.1007/s00415-006-0409-3. Epub 2007 Mar 31.'}, {'pmid': '27741285', 'type': 'BACKGROUND', 'citation': 'Aho-Ozhan HE, Keller J, Heimrath J, Uttner I, Kassubek J, Birbaumer N, Ludolph AC, Lule D. Perception of Emotional Facial Expressions in Amyotrophic Lateral Sclerosis (ALS) at Behavioural and Brain Metabolic Level. PLoS One. 2016 Oct 14;11(10):e0164655. doi: 10.1371/journal.pone.0164655. eCollection 2016.'}, {'pmid': '30949121', 'type': 'BACKGROUND', 'citation': 'Finegan E, Chipika RH, Li Hi Shing S, Hardiman O, Bede P. Pathological Crying and Laughing in Motor Neuron Disease: Pathobiology, Screening, Intervention. Front Neurol. 2019 Mar 21;10:260. doi: 10.3389/fneur.2019.00260. eCollection 2019.'}, {'pmid': '30915018', 'type': 'BACKGROUND', 'citation': 'Caga J, Hsieh S, Lillo P, Dudley K, Mioshi E. The Impact of Cognitive and Behavioral Symptoms on ALS Patients and Their Caregivers. Front Neurol. 2019 Mar 11;10:192. doi: 10.3389/fneur.2019.00192. eCollection 2019.'}, {'pmid': '28671483', 'type': 'BACKGROUND', 'citation': 'de Wit J, Bakker LA, van Groenestijn AC, van den Berg LH, Schroder CD, Visser-Meily JMA, Beelen A. Caregiver burden in amyotrophic lateral sclerosis: A systematic review. Palliat Med. 2018 Jan;32(1):231-245. doi: 10.1177/0269216317709965. Epub 2017 Jul 3.'}, {'pmid': '16344521', 'type': 'BACKGROUND', 'citation': 'Olney RK, Murphy J, Forshew D, Garwood E, Miller BL, Langmore S, Kohn MA, Lomen-Hoerth C. The effects of executive and behavioral dysfunction on the course of ALS. Neurology. 2005 Dec 13;65(11):1774-7. doi: 10.1212/01.wnl.0000188759.87240.8b.'}, {'pmid': '11442324', 'type': 'BACKGROUND', 'citation': 'Borasio GD, Miller RG. Clinical characteristics and management of ALS. Semin Neurol. 2001 Jun;21(2):155-66. doi: 10.1055/s-2001-15268.'}, {'pmid': '31551700', 'type': 'BACKGROUND', 'citation': 'Benbrika S, Desgranges B, Eustache F, Viader F. Cognitive, Emotional and Psychological Manifestations in Amyotrophic Lateral Sclerosis at Baseline and Overtime: A Review. Front Neurosci. 2019 Sep 10;13:951. doi: 10.3389/fnins.2019.00951. eCollection 2019.'}, {'pmid': '23989341', 'type': 'BACKGROUND', 'citation': 'Lule D, Ehlich B, Lang D, Sorg S, Heimrath J, Kubler A, Birbaumer N, Ludolph AC. Quality of life in fatal disease: the flawed judgement of the social environment. J Neurol. 2013 Nov;260(11):2836-43. doi: 10.1007/s00415-013-7068-y. Epub 2013 Aug 30.'}, {'pmid': '33609899', 'type': 'BACKGROUND', 'citation': 'Garcia-Cordero I, Migeot J, Fittipaldi S, Aquino A, Campo CG, Garcia A, Ibanez A. Metacognition of emotion recognition across neurodegenerative diseases. Cortex. 2021 Apr;137:93-107. doi: 10.1016/j.cortex.2020.12.023. Epub 2021 Jan 28.'}, {'pmid': '11464847', 'type': 'BACKGROUND', 'citation': 'Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.'}, {'pmid': '28343960', 'type': 'BACKGROUND', 'citation': 'Wang S, Adolphs R. Reduced specificity in emotion judgment in people with autism spectrum disorder. Neuropsychologia. 2017 May;99:286-295. doi: 10.1016/j.neuropsychologia.2017.03.024. Epub 2017 Mar 24.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* How people with ALS judge happy and angry faces and what their "insight" into these judgements are like\n* 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.\n\nResearchers 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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Residents of Aarhus and Aalborg\n* Patients at Aarhus University Hospital\n* Patients at Aalborg University Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ALS patients, ambulant and hospitalized\n\n * Able to give informed consent\n * Diagnosed with ALS or probable ALS according to the existing revision of the El Escorial Criteria 21,22.\n* Patients with a peripheral neuromuscular disease, ambulant and hospitalized\n\n * Able to give informed consent\n * Diagnosed with a peripheral neuromuscular disease, that does not affect CNS, including but not limited to Myasthenia Gravis and polyneuropathy\n* Healthy controls\n\n * Able to give informed consent\n * Age and gender matched to ALS patients\n\nExclusion Criteria:\n\n* All Participants\n\n * Other severe medical, neurological, or psychiatric disorders\n * Visual impairment to an extent that interferes with the ability to perform of the test\n * Severe motor or cognitive deficits, to the extent that the test-task cannot be performed\n * Alcohol or drug abuse to an extent the interferes with task performance\n* Patients with a peripheral neuromuscular disease\n\n ● Familial predisposition to ALS\n* Healthy controls\n\n * Familial predisposition to ALS (first degree relatives)\n * Medical treatment that affects the central nervous system (e.g., antidepressants)'}, 'identificationModule': {'nctId': 'NCT06566651', 'briefTitle': 'Emotion Processing Among Patients With ALS', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Emotion and Interoception Processing in ALS', 'orgStudyIdInfo': {'id': 'emotionperceptionALS11072308'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Amyotrophic Lateral Sclerosis (ALS)', 'description': 'People diagnosed or suspected of having the neurodegenerative disease Amyotrophic Lateral Sclerosis (ALS)', 'interventionNames': ['Other: Emotion Discrimination Task (EDT)']}, {'label': 'Neuromuscular', 'description': 'People diagnosed with a neuromuscular disease other than ALS', 'interventionNames': ['Other: Emotion Discrimination Task (EDT)']}, {'label': 'Control', 'description': 'Healthy people', 'interventionNames': ['Other: Emotion Discrimination Task (EDT)']}], 'interventions': [{'name': 'Emotion Discrimination Task (EDT)', 'type': 'OTHER', 'description': 'It estimates the subjective bias and sensitivity in discriminating between happy and angry facial expressions of different intensities of emotional expression', 'armGroupLabels': ['Amyotrophic Lateral Sclerosis (ALS)', 'Control', 'Neuromuscular']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'state': 'Central Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mia B Heintzelmann, Cand.med', 'role': 'CONTACT', 'email': 'minielse@rm.dk', 'phone': '78454255'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '9000', 'city': 'Aalborg', 'state': 'Region Nordjulland', 'status': 'NOT_YET_RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Jakob U Blicher, Ph.D', 'role': 'CONTACT', 'email': 'jbli@cfin.au.dk', 'phone': '78469939'}], 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'centralContacts': [{'name': 'Mia B Heintzelmann, Cand.med', 'role': 'CONTACT', 'email': 'minielse@rm.dk', 'phone': '78454255'}, {'name': 'Camilla Hakala, Bach.psych', 'role': 'CONTACT', 'email': 'caha@cfin.au.dk', 'phone': '26332857'}], 'overallOfficials': [{'name': 'Mia B Heintzelmann, Cand.med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'timeFrame': 'After the anonymizing the data, which is set to happen after collecting the data from the last participant being tested, the data will become available. The data will be available for minimum of 3 years.', 'ipdSharing': 'YES', 'description': 'All collected IPD. Once the data is fully anonymized, they may be released on public scientific repositories such as Github or Figshare.', 'accessCriteria': 'Through approval by Aarhus University Hospital or Region Midtjylland can individuals receive the collected data. The data can potentially be used as part of a masters thesis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'Aalborg University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.d. fellow', 'investigatorFullName': 'Mia Heintzelmann', 'investigatorAffiliation': 'University of Aarhus'}}}}