Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT04006418
Status:
RECRUITING
Last Update Posted:
2022-01-19
First Post:
2019-07-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Registered Cohort Study on Spastic Paraplegia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010264', 'term': 'Paraplegia'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2049-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-16', 'studyFirstSubmitDate': '2019-07-01', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spastic Paraplegia Rating Scale (SPRS)', 'timeFrame': '6 months', 'description': 'Disease severity will be assessed by application of the Spastic Paraplegia Rating Scale (SPRS), a clinical rating scale measuring disease severity in Hereditary Spastic Paraplegia (Schule et al. Neurology 2006). The SPRS contains 13 items, each ranging from 0 to 4 points. The total score is calculated as the sum of all items, yielding a range for the total score between 0 and 52. Hereby, higher SPRS total scores indicate more severe disease.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spastic Paraplegia']}, 'referencesModule': {'references': [{'pmid': '39853345', 'type': 'DERIVED', 'citation': 'Zhang F, Hu J, Xiao Z, Lin C, Huang Z, Wang N, Liu Y. Spinal cord cross sign: a potential marker for hereditary spastic paraplegia type 5. Neuroradiology. 2025 Apr;67(4):1081-1090. doi: 10.1007/s00234-025-03543-y. Epub 2025 Jan 24.'}, {'pmid': '38651515', 'type': 'DERIVED', 'citation': 'Tu Y, Liu Y, Fan S, Weng J, Li M, Zhang F, Fu Y, Hu J. Relationship between brain white matter damage and grey matter atrophy in hereditary spastic paraplegia types 4 and 5. Eur J Neurol. 2024 Aug;31(8):e16310. doi: 10.1111/ene.16310. Epub 2024 Apr 23.'}, {'pmid': '35017251', 'type': 'DERIVED', 'citation': 'Qiu YS, Zeng YH, Yuan RY, Ye ZX, Bi J, Lin XH, Chen YJ, Wang MW, Liu Y, Yao SB, Chen YK, Jiang JY, Lin Y, Lin X, Wang N, Fu Y, Chen WJ. Chinese patients with hereditary spastic paraplegias (HSPs): a protocol for a hospital-based cohort study. BMJ Open. 2022 Jan 11;12(1):e054011. doi: 10.1136/bmjopen-2021-054011.'}, {'pmid': '34538260', 'type': 'DERIVED', 'citation': 'Lin Q, Liu Y, Ye Z, Hu J, Cai W, Weng Q, Chen WJ, Wang N, Cao D, Lin Y, Fu Y. Potential markers for sample size estimations in hereditary spastic paraplegia type 5. Orphanet J Rare Dis. 2021 Sep 19;16(1):391. doi: 10.1186/s13023-021-02014-w.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the clinical spectrum and natural progression of Hereditary Spastic Paraplegias(HSP) and related disorders in a prospective multicenter natural history study, to assess the clinical, genetic and epigenetic features of patients with Spastic Paraplegias to optimize clinicalmanagement..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients diagnosed in hosipital and their's family", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with the clinical diagnosis of spastic paraplegia\n* Clinical diagnosis of patients with spastic paraplegia\n* Unrelated healthy controls\n\nExclusion Criteria:\n\n* Decline to participate.\n* There are serious interferences with individual participation and adherence to the research protocol, including but not limited to neurological, psychological, and/or medical conditions.'}, 'identificationModule': {'nctId': 'NCT04006418', 'briefTitle': 'A Registered Cohort Study on Spastic Paraplegia', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': 'A Registered Cohort Study on Spastic Paraplegia', 'orgStudyIdInfo': {'id': 'MRCTA,ECFAH OF FMU[2019]194'}}, 'armsInterventionsModule': {'interventions': [{'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wan-Jian Chen, MD, PhD', 'role': 'CONTACT', 'email': 'wanjinchen75@fjmu.edu.cn'}, {'name': 'Wan-Jin Chen', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ning Wang', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'First Affiliated Hospital Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Yi Lin, MD,PhD', 'role': 'CONTACT', 'email': 'wanjinchen75@fjmu.edu.cn', 'phone': '+13615039153'}, {'name': 'Wan-Jin Chen, MD,PhD', 'role': 'CONTACT', 'email': 'wanjinchen75@fjmu.edu.cn', 'phone': '+1386061359', 'phoneExt': '+1386061359'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wan-Jin Chen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The Vice-Director for the Department of Neurology', 'investigatorFullName': 'Wan-Jin Chen', 'investigatorAffiliation': 'First Affiliated Hospital of Fujian Medical University'}}}}