Spastic ParaplegiaSPG-TEPNCT06260982
Cognitive Disorders in Hereditary Spastic Paraplegia Type 4
An observational study of Spastic Paraplegia, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spastic Paraplegia
- What is being tested?
- 18-FDG-PET
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 2 Jan 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- dementia comorbidities or cognitive disorders unrelated to the pathology that may affect neuropsychological tests.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre hospitalier régional universitaire
Nancy, 54000
Mathilde Renaud, MD, PhD, m.renaud2@chru-nancy.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Spastic Paraplegia
- Being tested
- 18-FDG-PET
- Keywords
- Hereditary Spastic Paraplegia type 4, 18-FDG-PET, cognitive disorders
- Medical subject headings
- Paraplegia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18-FDG-PETRadiation
Also called neuropsychological testing
18-FDG-PET and neuropsychological tests (language, memory, visuo-spatial tests, etc.).
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive testing
we use detailed neuropsychological tests (MoCA)
Measured: baseline
Secondary outcomes (2)
Correlations between neuropsychological tests, clinical examination, PET and general data.
Measured: baseline
Genotype/Phenotype correlations
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Jan 2022
- Primary completionJan 2025 (estimated)
- Study completion2 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic ParaplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RENAUD Mathilde, Central Hospital, Nancy, France
- Investigators
- Mathilde Renaud, Principal investigator, Central Hospital Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260982
- Sponsor's protocol ID
- 2021PI148
- Acronym
- SPG-TEP
- Status last verified
- Feb 2024
- First submitted
- 26 Jun 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Disorders and Metabolism in 18-FDG- PET in Hereditary Spastic Paraplegia Type 4 (SPG4)
- ClinicalTrials.gov ID
- NCT06260982
- Acronym / sponsor ID
- SPG-TEP / 2021PI148
- Conditions
- Spastic Paraplegia
- Keywords
- Hereditary Spastic Paraplegia type 4, 18-FDG-PET, cognitive disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- 2 Jan 2025 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- dementia comorbidities or cognitive disorders unrelated to the pathology that may affect neuropsychological tests.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18-FDG-PETAlso: neuropsychological testing18-FDG-PET and neuropsychological tests (language, memory, visuo-spatial tests, etc.). | Radiation | – |
Primary outcome
cognitive testing
Time frame: baseline
we use detailed neuropsychological tests (MoCA)
2 secondary outcomes
Correlations between neuropsychological tests, clinical examination, PET and general data.
Time frame: baseline
Genotype/Phenotype correlations
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathilde Renaud principal investigator
Central Hospital Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic Paraplegia, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Renaud (+333 83 85 17 80, m.renaud2@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive testing (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.