The preSPG4 Study - Studying the Prodromal and Early Phase of SPG4
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity Hospital Tuebingen
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- SPRS Score and clinical signs
- Cognition Testing using CANTAB
- Lumbar Puncture and blood draw
- MRI
- Electrophysiology
- Testing functional performance
- Non motor symptoms
Treatment groups
200 Participants
are divided into 3 treatment groupsLocations
1University Hospital Tübingen, Center for Neurology72076, Tübingen Germany
Sponsors and collaborators
University Hospital Tuebingen
Lead sponsor
Source ClinicalTrials.gov