Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT06043518
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2023-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CNS Changes Following Upper Limb Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C565682', 'term': 'Amputation, Congenital'}, {'id': 'D004480', 'term': 'Ectromelia'}], 'ancestors': [{'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-12', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of functional MRI (fMRI) parameter between 2 to 4 time points', 'timeFrame': 'Up to 50 weeks', 'description': 'Change of brain activities is assessed between 2 to 4 time points using fMRI during resting-state or a specific task in patients with congenital amputations and compared to healthy controls'}], 'secondaryOutcomes': [{'measure': 'Conventional magnetic resonance imaging (MRI) parameter', 'timeFrame': 'Up to 50 weeks', 'description': 'Structural characteristics in the brain and cervical spinal cord are assessed in patients with congenital upper-limb amputations using conventional MRI and compared to healthy controls'}, {'measure': 'Amputees: Motor Activity Log questionnaire', 'timeFrame': 'Up to 50 weeks', 'description': 'Evaluation of residual limb and/or prosthesis usage as compared to other body parts via a questionnaire and behavioural assessments.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plasticity', 'Congenital amputee', 'Upper limb amelia', 'Somatotopy', 'Functional MRI', 'Hand', 'Reorganisation'], 'conditions': ['Amputation, Congenital', 'Upper Limb; Amelia']}, 'descriptionModule': {'briefSummary': "The objective of this study is to better understand the structural and functional changes that the central nervous system (CNS) undergoes following congenital upper limb loss. The focus is on the brain's sensory processing and how neuronal changes may relate to clinical measures. By doing so, the hope is to gain insight into the contribution of critical periods to the plasticity of the sensorimotor processing stream. Both macroscopic and microscopic changes of the brain will be examined in individuals with upper limb amelia and compared to healthy controls. fMRI will be combined with behavioural testing to understand which clinical and behavioural determinants drive somatosensory representations along the entire somatosensory processing stream. Using advanced imaging techniques, the aim is to investigate the contribution of brainstem reorganisation to plasticity observed at the cortical level and, by doing so, gain a better understanding of the mechanistic underpinnings of functional reorganisation. Overall, the hope is to provide the first mechanistic insight into whether early life experiences are crucial for the development of the relay nuclei in the central nervous system and how these changes relate to clinical measures such as adaptive behaviours or pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an upper-limb amputation and healthy subjects.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria - Patients:\n\n* Age 18-75\n* Upper-limb congenital amputees with complete absence of a hand\n* Signed informed consent\n\nExclusion Criteria - Patients:\n\n* Contraindications to magnetic resonance imaging\n* Neurological impairment of body function impairments not induced by spinal cord injury\n* BMI \\> 40\n* Pregnancy\n* Claustrophobia\n\nInclusion Criteria - Healthy subjects:\n\n* Age 18-75\n* Signed Informed consent\n\nExclusion Criteria - Healthy subjects:\n\n* Contraindications to magnetic resonance imaging\n* Pregnancy\n* Neurological illness\n* Impairment of body function induced by a congenital upper-limb amputation\n* Claustrophobia\n* BMI \\> 40'}, 'identificationModule': {'nctId': 'NCT06043518', 'briefTitle': 'CNS Changes Following Upper Limb Loss', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System', 'orgStudyIdInfo': {'id': '2018-00937 - Upper Limb Loss'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with congenital amputation', 'interventionNames': ['Diagnostic Test: MRI']}, {'label': 'Healthy subjects', 'interventionNames': ['Diagnostic Test: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Use of functional and structural MRI in both the brain and the spinal cord as well as questionnaires and clinical measures of motor function', 'armGroupLabels': ['Patients with congenital amputation']}, {'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Use of functional and structural MRI in both the brain and the spinal cord and questionnaires.', 'armGroupLabels': ['Healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Paige Howell, PhD', 'role': 'CONTACT', 'email': 'paige.howell@hest.ethz.ch', 'phone': '+41 44 632 32 94'}], 'facility': 'Balgrist Campus', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Paige Howell, PhD', 'role': 'CONTACT', 'email': 'paige.howell@hest.ethz.ch', 'phone': '+41 44 632 32 94'}, {'name': 'Sanne Kikkert', 'role': 'CONTACT', 'email': 'sanne.kikkert@balgrist.ch', 'phone': '+41 44 632 32 94'}], 'overallOfficials': [{'name': 'Patrick Freund, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'ETH Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}