Cognitive Disorders in Hereditary Spastic Paraplegia Type 4 (SPG-TEP)

February 7, 2024 updated by: RENAUD Mathilde, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nancy, France, 54000
        • Recruiting
        • Centre Hospitalier Régional Universitaire
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cognitive testing
Time Frame: baseline
we use detailed neuropsychological tests (MoCA)
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlations between neuropsychological tests, clinical examination, PET and general data.
Time Frame: baseline
baseline
Genotype/Phenotype correlations
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Mathilde Renaud, Central Hospital Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 2, 2025

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Estimated)

February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PI148

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spastic Paraplegia

Clinical Trials on 18-FDG-PET

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe