Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT05764434
Status:
UNKNOWN
Last Update Posted:
2023-11-14
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ALS Spinal Cord Gray and White Matter Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood Samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-13', 'studyFirstSubmitDate': '2023-02-27', 'studyFirstSubmitQcDate': '2023-03-09', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spinal Cord Gray Matter Baseline', 'timeFrame': 'baseline', 'description': 'Spinal cord gray matter cross-sectional area in mm2'}, {'measure': 'Spinal Cord Gray Matter 6 month follow-up', 'timeFrame': '6 month follow-up', 'description': 'Spinal cord gray matter cross-sectional area in mm2'}, {'measure': 'Spinal Cord Gray Matter 12 month follow-up', 'timeFrame': '12 month follow-up', 'description': 'Spinal cord gray matter cross-sectional area in mm2'}, {'measure': 'Spinal Cord Gray Matter 18 month follow-up', 'timeFrame': '18 month follow-up', 'description': 'Spinal cord gray matter cross-sectional area in mm2'}, {'measure': 'Spinal Cord Gray Matter 24 month follow-up', 'timeFrame': '24 month follow-up', 'description': 'Spinal cord gray matter cross-sectional area in mm2'}], 'secondaryOutcomes': [{'measure': 'Spinal Cord White Matter', 'timeFrame': 'baseline, months 6, 12, 18 and 24', 'description': 'Spinal cord white matter cross-sectional area in mm2'}, {'measure': 'Spinal Cord Total Area', 'timeFrame': 'baseline, months 6, 12, 18 and 24', 'description': 'Total spinal cord cross-sectional area in mm2'}, {'measure': 'ALS Functional Rating Scale', 'timeFrame': 'baseline, months 6, 12, 18 and 24', 'description': 'ALS Functional Rating Scale (ALSFRS-R)'}, {'measure': 'Neurofilament Light Chain Levels', 'timeFrame': 'baseline, months 6, 12, 18 and 24', 'description': 'Neurofilament Light Chain Levels (pg/ml)'}, {'measure': 'Sniff nasal inspiratory pressure', 'timeFrame': 'baseline, months 6, 12, 18 and 24', 'description': 'Sniff nasal inspiratory pressure (SNIP) (cmH2O)'}, {'measure': 'Segmental Muscle Force', 'timeFrame': 'baseline, months 6, 12, 18 and 24', 'description': 'Segmental Muscle Force assessed by hand-held dynamometry (N)'}, {'measure': 'MUNIX', 'timeFrame': 'baseline, months 6, 12, 18 and 24', 'description': 'Motor Unit Number Index (MUNIX) in selected muscles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amyotrophic Lateral Sclerosis', 'Spinal Cord Magnetic Resonance Imaging'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': "This study aims to measure in vivo the spinal cord gray and white matter in patients with Amyotrophic Lateral Sclerosis and healthy persons that match the patients' age and sex using rAMIRA imaging, a novel Magnetic Resonance Imaging (MRI) method. Patients and healthy control persons prospectively undergo MRI examinations, clinical examinations including assessments of disability, and tests of muscle force using hand held dynamometry. Serum markers of neuro-axonal injury are also assessed.\n\nExaminations for patients and healthy control persons are scheduled every six months over a time span of two years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed with possible, probable, and definite Amyotrophic Lateral Sclerosis acc. to the El Escorial aged 18 years or older can participate in this study. Healthy control persons are chosen to individually match the included patients. Additionally, patients with other motor neuron diseases (not ALS) will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (patients):\n\n1. 18 years or older\n2. neurologist-confirmed possible, probable or definite ALS acc. to El Escorial criteria\n3. at baseline: able to lie in an MRI scanner for one hour\n\nExclusion Criteria (patients):\n\n1. active other neurological or neuromuscular condition explaining the symptoms or a significant part of it\n2. other neurological or neuromuscular conditions interfering with the examinations\n3. severe cervical spinal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study\n4. other severe chronic disease\n5. pregnancy\n6. general contraindications against MRI scanning (e.g. metal implants, pacemakers)\n7. not able to read the patient information due to language barriers (patient information in English and French may be provided)\n8. major cognitive deficit impacting the ability to read and understand the patient information and/or to follow the instructions of the study personnel\n\nInclusion criteria (healthy control persons):\n\n1. 18 years or older\n2. able to lie in MRI scanner for one hour\n\nExclusion criteria (healthy control persons):\n\n1. neurological or neuromuscular conditions\n2. other severe chronic disease\n3. pregnancy\n4. general contraindications against MRI scanning (e.g. metal implants, pacemakers)\n5. relevant cervical spinal canal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study\n6. not able to read the patient information due to language barriers (patient information in English and French may be provided)\n\nInclusion criteria (patients with Motor Neuron Diseases other than ALS):\n\n1. 18 years or older\n2. neurologist-confirmed Motor Neuron Disease (not ALS)\n3. able to lie in MRI scanner for one hour\n\nExclusion criteria (patients with Motor Neuron Diseases other than ALS):\n\n1. other severe neurologic disease\n2. other severe chronic disease\n3. pregnancy\n4. general contraindications against MRI scanning (e.g. metal implants, pacemakers)\n5. relevant cervical spinal canal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study\n6. not able to read the patient information due to language barriers (patient information in English and French may be provided)'}, 'identificationModule': {'nctId': 'NCT05764434', 'briefTitle': 'ALS Spinal Cord Gray and White Matter Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Spinal Cord Gray and White Matter Imaging in Amyotrophic Lateral Sclerosis', 'orgStudyIdInfo': {'id': 'ALS_SC_MRI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Amyotrophic Lateral Sclerosis', 'description': 'Patients with a possible, probable, or definite diagnosis of Amyotrophic Lateral Sclerosis according to the El Escorial Criteria.', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Imaging']}, {'label': 'Healthy Control Persons', 'description': 'Healthy control persons matching the ALS patient group in sex and age', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Imaging']}, {'label': 'Patients with other Motor Neuron Diseases', 'description': 'Patients with Motor Neuron Diseases other than ALS', 'interventionNames': ['Diagnostic Test: Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Magnetic Resonance Imaging of the spinal cord using radially acquired Averaged Magnetization Inversion Recovery Acquisitions (rAMIRA)', 'armGroupLabels': ['Healthy Control Persons', 'Patients with Amyotrophic Lateral Sclerosis', 'Patients with other Motor Neuron Diseases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Regina Schlaeger, PD Dr.', 'role': 'CONTACT', 'email': 'regina.schlaeger@usb.ch', 'phone': '0041 61 328 67 49'}, {'name': 'Janina Wendebourg, Dr.', 'role': 'CONTACT', 'email': 'janina.wendebourg@usb.ch', 'phone': '0041 556 57 99'}], 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Regina Schlaeger, PD Dr.', 'role': 'CONTACT', 'email': 'regina.schlaeger@usb.ch', 'phone': '0041 61 328 67 49'}, {'name': 'Janina Wendebourg, Dr.', 'role': 'CONTACT', 'email': 'janina.wendebourg@usb.ch', 'phone': '0041 61 556 57 99'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr.', 'investigatorFullName': 'Regina Schlaeger', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}