A Registered Cohort Study on Spastic Paraplegia

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..

Study Overview

• Status: Recruiting
• Conditions: Spastic Paraplegia
• Intervention / Treatment: Other

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Yi Lin, MD,PhD; Phone Number: +13615039153; Email: wanjinchen75@fjmu.edu.cn
• Study Contact Backup: Name: Wan-Jin Chen, MD,PhD; Phone Number: +1386061359 +1386061359; Email: wanjinchen75@fjmu.edu.cn

Study Locations

• China
  • Fuzhou, China
    • Recruiting
    • First Affiliated Hospital Fujian Medical University
    • Principal Investigator: Wan-Jin Chen
    • Contact: Wan-Jian Chen, MD, PhD; Email: wanjinchen75@fjmu.edu.cn
    • Sub-Investigator: Ning Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed in hosipital and their's family

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wan-Jin Chen

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Orphanet J Rare Dis. 2021 Oct 27;16(1):451.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): December 1, 2039
• Study Completion (Anticipated): December 1, 2049

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 16, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Paralysis; Muscle Hypertonia; Muscle Spasticity; Paraplegia
• Other Study ID Numbers: MRCTA,ECFAH OF FMU[2019]194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No