Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT06396260
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2024-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Longitudinal imaging study. Baseline acquisition of DKI and resting state MEG of ALS and matched healthy controls. Participants with ALS will be monitored for a period of 6 months for symptoms of PBA. If developed, or not developed after 6 months, follow-up DKI and MEG will be acquired.\n\nAn additional sub-study will be performed in patients with ALS and newly developed PBA, where resting state MEG will be acquired after at least 7 days of symptomatic treatment independent of the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2024-04-29', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean kurtosis', 'timeFrame': 'Baseline measurement and up to 6 month follow-up measurements', 'description': 'A measurement of kurtosis diffusion signal in pseudobulbar affect-affiliated brains areas (prefrontal lobe, pons, cerebellum, motor cortex, temporal lobe) derived from Diffusion kurtosis imaging (DKI)-MRI'}, {'measure': 'Spectral connectivity', 'timeFrame': 'Baseline measurement and up to 6 month follow-up measurements', 'description': 'Estimation of connectivity (correlation between spikes of activity) between pseudobulbar affect afflilated cortical brain areas (prefrontal cortex, motor cortex, temporal lobe) derived through resting state magnetoencelphalography (MEG)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diffusion Kurtosis Imaging', 'Magnetoencephalography', 'Connectivity'], 'conditions': ['Amyotrophic Lateral Sclerosis', 'Pseudobulbar Affect']}, 'descriptionModule': {'briefSummary': 'The investigators aim to elucidate characteristics of structural and functional brain connectivity in patients with amyotrophic lateral sclerosis (ALS) and pseudobulbar affect (PBA) using diffusion kurtosis imaging (DKI) and magnetoencephalography (MEG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with ALS in the last 6 months according to Gold Coast Criteria\n\nExclusion Criteria:\n\n* \\- Lack of ability to answer survey through own ability or through a surrogate, for example by hand controlled, eye-controlled computer and/or tablet, or through telephone interview.\n* Lack of ability to cooperate.\n* Pregnancy\n* Drug addiction defined as the non-prescribed use of cannabis, opioids, or other narcotics.\n* Alcohol addiction defined as over 21 units weekly.\n* Lesional neurological diseases, such as stroke, tumor or multiple sclerosis\n* Epilepsy\n* Neurodegenerative diseases other than ALS\n* Severe psychiatric disease such as major depression disorder, bipolar disease or schizophrenia\n* Contraindication for MRI and MEG scan according to hospital guidelines\n* Severe liver or kidney disease\n* Dysregulated heart disease\n* Ongoing treatment with any antidepressants or any antipsychotics at recruitment.\n* Diagnosed with frontotemporal dementia.'}, 'identificationModule': {'nctId': 'NCT06396260', 'briefTitle': 'Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect', 'orgStudyIdInfo': {'id': 'F2024-014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Sex- and age matched, healthy control. Will only have baseline DKI and MEG performed.', 'interventionNames': ['Other: Diffusion Kurtosis Imaging (DKI)', 'Other: Resting State Magnetoencephalography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ALS without PBA', 'description': 'ALS patient without PBA, either at baseline and 6 month follow-up', 'interventionNames': ['Other: Diffusion Kurtosis Imaging (DKI)', 'Other: Resting State Magnetoencephalography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ALS with PBA', 'description': 'ALS patient with PBA, either at baseline or follow-up', 'interventionNames': ['Other: Diffusion Kurtosis Imaging (DKI)', 'Other: Resting State Magnetoencephalography']}], 'interventions': [{'name': 'Diffusion Kurtosis Imaging (DKI)', 'type': 'OTHER', 'description': 'Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue', 'armGroupLabels': ['ALS with PBA', 'ALS without PBA', 'Control']}, {'name': 'Resting State Magnetoencephalography', 'type': 'OTHER', 'description': 'Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)', 'armGroupLabels': ['ALS with PBA', 'ALS without PBA', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9500', 'city': 'Aalborg', 'state': 'Northern Jutland', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Christian Steenkjaer', 'role': 'CONTACT', 'phone': '22144295'}], 'facility': 'Aalborg University hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'centralContacts': [{'name': 'Christian Holm Steenkjær', 'role': 'CONTACT', 'email': 'c.steenkjaer@rn.dk', 'phone': '+4597660000'}, {'name': 'Blicher', 'role': 'CONTACT', 'email': 'Au568472@uni.au.dk', 'phone': '+4522144295'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data is not planned to be available to other researchers. However findings from this study is planned to be published in peer-reviewed journal regardless of positive/negative findings'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Aarhus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christian Holm Steenkjær', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}