The preSPG4 Study - Studying the Prodromal and Early Phase of SPG4
Studying the Prodromal and Early Phase of Hereditary Spastic Paraplegia Type 4 (SPG4)
University Hospital Tuebingen
200 participants
Jul 1, 2018
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria3
- First degree relatives (parents, offspring, and sibs) of SPG4 patients or symptomatic individuals with known SPAST mutation
- Age 18 to 70 years
- Written, informed consent (patient)
Exclusion Criteria3
- No known SPAST-mutation within the family
- Manifest spastic gait (subclinical signs like increased deep tendon reflexes, positive Babinski sign are allowed)
- Participation in interventional trials
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Interventions
Patients will clinically characterized by using the SPRS Score and the inventory V3
Patients will be tested using the CANTAB
Biomaterial will be collected (not obligate) to compare e.g. Nfl levels in serum and CSF
MRI will be used to reveal presymptomatic brain morphology changes (not obligate)
Electrophysiological tests will be used to characterize patients better.
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
By using a number of different tests we try to identify other non-motor symptoms which might manifest prior to disease onset.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03206190