Integrated Functional Evaluation of the Cerebellum (NCT04288128) | Clinical Trial Compass
CompletedNot Applicable
Integrated Functional Evaluation of the Cerebellum
France40 participantsStarted 2020-05-28
Plain-language summary
One of the main objectives of this project is to validate potential biological, clinical and/or imaging biomarkers in SCA patients through a multimodal assessment, for future ASOs trials.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Common inclusion criteria for all participants:
* Ability to walk independently 30 foot without an assistive device
* Able to stand unassisted for 30 seconds
* Affiliated with the French social security, or a social security equivalent, if they are not French.
* Capacity to consent
* Signed Informed Consent by the subject
* Ability to undergo MRI scanning
Inclusion criteria for SCA patients:
* Genetic diagnosis of SCA 2 or 7 (available CAG repeat length)
* SARA score ≤15
Inclusion criteria for control participants:
* Negative Genetic diagnosis of SCA2/SCA7 available
* No significant neurological symptoms
* SARA score \< 5
Common inclusion criteria for elective participant for CSF sampling:
• Ability to undergo a lumbar puncture
Exclusion criteria
* Subjects currently receiving, or having received within 2 months prior to enrolment into this study, any investigational drug
* Pregnancy or breastfeeding
* Genotype consistent with other inherited ataxias
* Changes in coordinative physical and occupational therapy for ataxia 2 months prior to study participation
* Concomitant disorder(s) or condition(s) that affects assessment of ataxia or severity of ataxia during this study
* Contra-indications to MRI examination
* Person deprived of their liberty by judicial or administrative decision
What they're measuring
1
Identification of biological, clinical and/or imaging biomarkers in SCA2 and SCA7 patients mutations carriers and patients through a multimodal assessment over one year to prepare therapeutic trials