Cognitive Disorders in Hereditary Spastic Paraplegia Type 4

Spastic Paraplegia Clinical Trial

— SPG-TEP  

Official title:

Cognitive Disorders and Metabolism in 18-FDG- PET in Hereditary Spastic Paraplegia Type 4 (SPG4)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06260982
• Other study ID #: 2021PI148
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 2, 2025

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: Mathilde Renaud
• Phone: +333 83 85 17 80
• Email: m.renaud2[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Hereditary spastic paraplegia type 4 is the most frequent mutation of hereditary spastic paraplegias. It is commonly described as pure, with progressive weakness of the lower limbs, pyramidal syndrome and vesico-sphincter disorders. However, cognitive disorders have been reported for over 20 years, but remain poorly characterized.

Description:

Our primary objective is to describe a pattern of cognitive impairment in Hereditary Spastic Paraplegia type 4 using 18-FDG-PET metabolic imaging. As secondary objectives, we wish to study the presence of correlations between neuropsychological tests, clinical examination, 18-FDG-PET data and general and genetic data of the pathology. We also wish to investigate correlations between genotype and phenotype.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2, 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient over 18 years of age, living in the Grand Est region (France)
• Patient with a pathogenic or probably pathogenic variant (class 4 or 5) in the SPAST gene.

Exclusion Criteria:

• dementia comorbidities or cognitive disorders unrelated to the pathology that may affect neuropsychological tests.

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Dysfunction
• Muscle Spasticity
• Paraplegia
• Spastic Paraplegia
• Spastic Paraplegia, Hereditary

Intervention

Radiation:
• 18-FDG-PET
18-FDG-PET and neuropsychological tests (language, memory, visuo-spatial tests, etc.).

Locations

Country	Name	City	State
France	Centre hospitalier régional universitaire	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive testing	we use detailed neuropsychological tests (MoCA)	baseline
Secondary	Correlations between neuropsychological tests, clinical examination, PET and general data.		baseline
Secondary	Genotype/Phenotype correlations		baseline