PROSPAX: An integrated multimodal progression chart in spastic ataxias

PROSPAX: An integrated multimodal progression chart in spastic ataxias - PROSPAX

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55341

Enrollment

Registered

2020-09-23

Start date

2021-01-25

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ataxia disorder of coordination

Interventions

None listed

Eligibility

Age

16 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
- Annual rate of change measured by SARA and SPRS.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results