PROSPAX: An integrated multimodal progression chart in spastic ataxias

Recruiting

• Conditions: Ataxia; disorder of coordination; 10029299; 10028037

• Registration Number: NL-OMON55341
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

• Participant is 16 years or older;
• Participant has a proven mutation in the SACS (ARSACS) or SPG7 gene (patient
cohort only).
• Participant is able and willing to sign the informed consent.

Exclusion Criteria

• Prior history of any neurological disorder, or another disease that
significantly influences motor function;
• General contraindications for MRI (only for MRI study).

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Annual rate of change measured by SARA and SPRS. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Annual rate of change measured by newly designed SPAX composite scale.<br /><br>- Longitudinal change in patient-reported, MRI, clinical assessments and blood<br /><br>biomarker outcome measures in patients versus controls.<br /><br>- Disease progression measured by alternative patient-centered, digital<br /><br>sensor-based smartwatch biomarkers via the SPAX.app (mobile SPAX disease score).<br /><br><br /><br>In addition to the endpoints, demographical characteristics (age, gender,<br /><br>disease duration) and mutation type, will be collected at baseline.</p><br>