A Registered Cohort Study on Spastic Paraplegia

Spastic Paraplegia Clinical Trial

Official title:

A Registered Cohort Study on Spastic Paraplegia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04006418
• Other study ID #: MRCTA,ECFAH OF FMU[2019]194
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: December 2049

Study information

• Verified date: January 2022
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Yi Lin, MD,PhD
• Phone: +13615039153
• Email: wanjinchen75[@]fjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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..

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2049
• Est. primary completion date: December 2039
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Spasticity
• Paraplegia
• Spastic Paraplegia

Locations

Country	Name	City	State
China	First Affiliated Hospital Fujian Medical University	Fuzhou

Sponsors (1)

Lead Sponsor	Collaborator
Wan-Jin Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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