A Registered Cohort Study on Spastic Paraplegia

NCT04006418 | Recruiting DMC

• 1 other identifier: MRCTA,ECFAH OF FMU[2019]194
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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..

Conditions

Spastic Paraplegia

Outcome Measures

Primary Outcomes (1)

• Spastic Paraplegia Rating Scale (SPRS)

  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.

  6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed in hosipital and their's family

You may qualify if:

• Patients with the clinical diagnosis of spastic paraplegia
• Clinical diagnosis of patients with spastic paraplegia
• Unrelated healthy controls

You may not qualify if:

• Decline to participate.
• There are serious interferences with individual participation and adherence to the research protocol, including but not limited to neurological, psychological, and/or medical conditions.

Sponsors & Collaborators

• Wan-Jin Chen: lead

Study Sites (1)

First Affiliated Hospital Fujian Medical University

Fuzhou, China

RECRUITING

Related Publications (4)

• 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: 39853345 DERIVED

• 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: 38651515 DERIVED

• 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: 35017251 DERIVED

• 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.

  PMID: 34538260 DERIVED

MeSH Terms

Conditions

Paraplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yi Lin, MD,PhD

CONTACT

+13615039153; wanjinchen75@fjmu.edu.cn

Wan-Jin Chen, MD,PhD

CONTACT

+1386061359; wanjinchen75@fjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Vice-Director for the Department of Neurology

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: July 1, 2019
• Primary Completion (Estimated): December 1, 2039
• Study Completion (Estimated): December 1, 2049
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)