NCT06260982

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2025

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

June 26, 2023

Last Update Submit

February 7, 2024

Conditions

Spastic Paraplegia

Keywords

Hereditary Spastic Paraplegia type 418-FDG-PETcognitive disorders

Outcome Measures

Primary Outcomes (1)

  • cognitive testing

    we use detailed neuropsychological tests (MoCA)

    baseline

Secondary Outcomes (2)

  • Correlations between neuropsychological tests, clinical examination, PET and general data.

    baseline

  • Genotype/Phenotype correlations

    baseline

Interventions

18-FDG-PETRADIATION

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

Also known as: neuropsychological testing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients followed in the Grand Est region for type 4 spastic paraplegia with identification of a pathogenic or probably pathogenic variant in the SPAST gene.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier régional universitaire

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

ParaplegiaCognitive Dysfunction

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Mathilde Renaud

    Central Hospital Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathilde Renaud

CONTACT

+333 83 85 17 80m.renaud2@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 26, 2023

First Posted

February 15, 2024

Study Start

January 1, 2022

Primary Completion

January 1, 2025

Study Completion

January 2, 2025

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations

FR(1)