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RecruitingNCT04006418Updated Jan 19, 2022

A Registered Cohort Study on Spastic Paraplegia

An observational study in Spastic Paraplegia, sponsored by Wan-Jin Chen. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2022-01-19.

Sponsored by Wan-Jin Chen · Observational

From the registry’s dates

  • Started Jul 2019; still recruiting 7 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
500
Sex
All
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Study 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..

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Conditions studied

  • Spastic Paraplegia
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In context

Muscle Spasticity

704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.

This study's planned enrollment of 500 is above the median of 60 across 162 observational studies indexed under Muscle Spasticity.

Browse Muscle Spasticity studies →

Lead sponsor

Wan-Jin Chen is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients diagnosed in hosipital and their's family

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
500 participants (estimated)
Target follow-up
20 Years
Patient registry
Yes
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What researchers measure

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.

    Time frame: 6 months

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Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital Fujian Medical University
    Fuzhou, China
    • Wan-Jian Chen, MD, PhD · Contact · wanjinchen75@fjmu.edu.cn
    • Wan-Jin Chen · Principal investigator
    • Ning Wang · Sub investigator
    Recruiting
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References and documents

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. PubMed 35017251 ↗
  • 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. doi: 10.1186/s13023-021-02078-8. PubMed 34538260 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04006418
Lead sponsor
Wan-Jin Chen
Responsible party
Wan-Jin Chen (The Vice-Director for the Department of Neurology, First Affiliated Hospital of Fujian Medical University) — Sponsor-investigator
First posted
Jul 5, 2019
Start date
Jul 1, 2019
Primary completion
Dec 2039 (estimated)
Completion
Dec 2049 (estimated)
Last update
Jan 19, 2022

Study contacts

Yi Lin, MD,PhD
Contact
wanjinchen75@fjmu.edu.cn
+13615039153
Wan-Jin Chen, MD,PhD
Contact
wanjinchen75@fjmu.edu.cn
+1386061359 ext. +1386061359

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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