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The preSPG4 Study - Studying the Prodromal and Early Phase of SPG4
Sponsor: University Hospital Tuebingen
Summary
Study goals 1. Prospective longitudinal data on progression in the natural course of SPG4 in presymptomatic mutation carriers prior to clinical disease onset and in early stages of disease 2. Biomarkers providing objective measures of disease activity
Official title: Studying the Prodromal and Early Phase of Hereditary Spastic Paraplegia Type 4 (SPG4)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2018-07-01
Completion Date
2031-12
Last Updated
2022-08-23
Healthy Volunteers
No
Interventions
SPRS Score and clinical signs
Patients will clinically characterized by using the SPRS Score and the inventory V3
Cognition Testing using CANTAB
Patients will be tested using the CANTAB
Lumbar Puncture and blood draw
Biomaterial will be collected (not obligate) to compare e.g. Nfl levels in serum and CSF
MRI
MRI will be used to reveal presymptomatic brain morphology changes (not obligate)
Electrophysiology
Electrophysiological tests will be used to characterize patients better.
Testing functional performance
By using the 3 minute walk, 5 stair-climb test, and 10m walking test we will try to identify and measure subclinical progression prior to disease onset
Non motor symptoms
By using a number of different tests we try to identify other non-motor symptoms which might manifest prior to disease onset.
Locations (1)
University Hospital Tübingen, Center for Neurology
Tübingen, Germany